Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-00... | NCT03744468

NCT03744468

ID	Type	Description	Link
U1111-1278-0027	Other Identifier	UTN Number
2022-500694-14	EudraCT Number

Status Module

Description Module

Detailed Description

Blocking antibodies targeting programmed cell death protein-1 (PD-1) have achieved remarkable results in the treatment of many types of tumors. However, based upon the rate of primary and secondary resistance to PD-1 blockade, it was apparent that additional immuno-regulatory mechanism(s) underlie tumor immune escape. Indeed, research shows that the T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) pathway cooperates with PD-1 to maximize the suppression of effector tumor infiltrating lymphocytes (TILs) as well as promote resistance to anti-PD-1 therapy. Therefore, TIM-3 represents an ideal target with the potential to significantly improve and/or extend the therapeutic benefit of anti-PD-1 therapy to a greater number of participants.

TIM-3, Lymphocyte activation gene-3 (LAG-3), and PD-1 function as immune checkpoint receptors in the overlapping regulation of immune tolerance and have been shown to be co-overexpressed on the TILs from the participant samples of various solid tumors. Furthermore, emerging clinical data and preclinical data demonstrate co-expression of TIM-3, LAG-3, PD-1 often yield T cells exhausted immunophenotype (i.e., cytokine expression, proliferation etc.). Cancer cells take advantage of PD-1, TIM-3, and LAG-3 in inhibiting immune cells' function, and escape the immune surveillance. Based upon the overlapping expression profiles and immuno-regulatory functions, TIM-3 and LAG-3 mediated adaptive resistance, there was strong scientific rationale that simultaneous targeting of these checkpoint blockers, could potentially increase therapeutic benefit and might help to overcome the resistance arising due to anti-PD-(L)-1 therapy. Hence, this study evaluated the safety and preliminary efficacy of surzebiclimab (anti TIM-3), alcestobart (Anti-LAG-3) in combination with tislelizumab (anti PD-1) in patients with advanced solid tumors.

This was an open-label, multicenter, nonrandomized Phase 1 and Phase 2 clinical trial. Phase 1 determined the recommended phase 2 dose (RP2D) for the combination of surzebiclimab and tislelizumab. Phase 2 safety lead-in determined the RP2D for the combination of surzebiclimab, tislelizumab and/or alcestobart. Phase 2 dose expansion continued to evaluate the safety but also focus on the efficacy of the doublet or triplet treatment combination in select tumor types.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab	Experimental	Participants received surzebiclimab 2 mg intravenous (IV) infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	Drug: Surzebiclimab Drug: Tislelizumab
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Experimental	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	Drug: Surzebiclimab Drug: Tislelizumab
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab	Experimental	Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surzebiclimab	Drug	Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3	Phase 1 (Dose Escalation): Surzebiclimab 1600 mg Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An Adverse Event (AE) was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.	Up to 30 days after last dose of study drug (maximum treatment duration: up to 32.7 months)
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Surzebiclimab in Combination With Tislelizumab	The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 1, therefore the MAD was reported.	Up to 28 days
Phase 1: Recommended Phase 2 Dose (RP2D) of Surzebiclimab in Combination With Tislelizumab	The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.	Up to 28 days
Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs	An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.

Secondary Outcomes

Measure	Description	Time Frame
Phase 1: Overall Response Rate (ORR)	ORR was defined as the percentage of participants who had CR or PR. Per RECIST v.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.

Eligibility Module

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Chao Family Comprehensive Cancer Center		Orange	California	92868-3201	United States
University of Colorado Cancer Center

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab	Participants received surzebiclimab 2 mg intravenous (IV) infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 14, 2022	Jan 30, 2026

Arm/Group Information

ID	Title	Description
BG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG002	Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab	Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG003	Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab	Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG004	Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab	Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG005	Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab	Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG006	Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab	Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG007	Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab	Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
BG008	Phase 1 (Dose Escalation): Surzebiclimab 60 mg	Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
BG009	Phase 1 (Dose Escalation): Surzebiclimab 1600 mg	Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
BG010	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG011	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG012	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab	Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG013	Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + Surzebiclimab + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG014	Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG015	Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab	Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG016	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG017	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG018	Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG019	Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
BG020	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00066.0 BG00166.0 BG00253.3± 20.84 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG0000 BG0010 BG002

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

Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An Adverse Event (AE) was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.

Analysis was performed on safety analysis set.

Posted

Count of Participants

Participants

Up to 30 days after last dose of study drug (maximum treatment duration: up to 32.7 months)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG002	Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab	Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG003	Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab	Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Units	Counts
Participants	OG0001 OG0011 OG0023 OG003

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG0001 OG0011 OG0023 OG003

Primary

Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Surzebiclimab in Combination With Tislelizumab

The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 1, therefore the MAD was reported.

Analysis was performed on dose limiting toxicities (DLT) evaluable analysis set that included all participants who received at least 80% each of the assigned dose of surzebiclimab on Cycle 1 Day 1 and tislelizumab on Cycle 1 Day 8 and remained on the study during the 28-day DLT observation period for safety evaluation.

Posted

Number

milligram (mg)

Up to 28 days

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab + Tislelizumab	All participants received surzebiclimab IV on day 1 of each cycle and tislelizumab IV on day 8 of Cycle 1. If tolerated, participants received surzebiclimab along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Units	Counts
Participants

Primary

Phase 1: Recommended Phase 2 Dose (RP2D) of Surzebiclimab in Combination With Tislelizumab

The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.

Analysis was performed on all Phase 1 participants.

Posted

Number

milligram (mg)

Up to 28 days

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab + Tislelizumab	All participants received surzebiclimab IV on day 1 of each cycle and tislelizumab IV on day 8 of Cycle 1. If tolerated, participants received surzebiclimab along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Units	Counts
Participants	OG000

Primary

Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs

An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.

Analysis was performed on safety analysis set.

Posted

Count of Participants

Participants

Up to 30 days after last dose of study drug (maximum duration of treatment: up to 19.6 months in Cohort A and up to 21.5 months in Cohort B)

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001

Primary

Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Tislelizumab

The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.

Analysis was performed on DLT evaluable analysis set that included all participants who received at least 80% each of the assigned dose of study drug(s) in the combination treatments and remained on the study during the 21-day DLT observation period for safety evaluation.

Posted

Number

milligram (mg)

Up to 21 days

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Alcestobart + Tislelizumab	All participants received alcestobart IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Units	Counts
Participants	OG000

Primary

Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Surzebiclimab and Tislelizumab

The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.

Analysis was performed on DLT evaluable analysis set. Here, 'overall number of participants analyzed' signifies participants with data available for the analysis.

Posted

Number

milligram (mg)

Up to 21 days

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Alcestobart + Surzebiclimab + Tislelizumab	All participants received alcestobart IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Units	Counts
Participants	OG000

Primary

Phase 2 (Safety Lead-In): RP2D of Alcestobart in Combination With Surzebiclimab and Tislelizumab

Analysis was performed on DLT evaluable analysis set in Phase 2 participants. Here, 'Overall number of participants analyzed' signifies participants with data available for the analysis.

Posted

Number

milligram (mg)

Up to 21 days

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Alcestobart + Surzebiclimab + Tislelizumab	All participants received alcestobart IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Units	Counts
Participants	OG000

Primary

Phase 2 (Dose Expansion): Overall Response Rate (ORR)

ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)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 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 efficacy evaluable analysis set that included all dosed participants who had evaluable disease at baseline, and at least 1 evaluable postbaseline tumor response assessment unless any clinical progression of disease (PD) or death occurred before the first scheduled postbaseline tumor assessment.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to11.3 months, Cohort 5: up to 15.9 months

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab

Secondary

Phase 1: Overall Response Rate (ORR)

ORR was defined as the percentage of participants who had CR or PR. Per RECIST v.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 efficacy evaluable analysis set. The participant in the 'Phase 1 (Dose Escalation): Surzebiclimab 1600 mg' cohort was not included in the efficacy evaluable analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum time on study: up to 57.5 months

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Safety Lead- In): Overall Response Rate (ORR)

Analysis was performed on efficacy evaluable analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days..
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Disease Control Rate (DCR)

DCR was defined as the percentage of participants with a best overall response (BOR) of CR, PR, or stable disease (SD), per RECIST v.1.1. CR was defined as the 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. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

Analysis was performed on efficacy evaluable analysis set. The participant in the 'Phase 1 (Dose Escalation): Surzebiclimab 1600 mg' cohort was not included in the efficacy evaluable analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum time on study: up to 57.5 months

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001

Secondary

Phase 2 (Safety Lead-In): Disease Control Rate (DCR)

DCR was defined as the percentage of participants with a BOR of CR, PR, or SD, per RECIST v.1.1. CR was defined as the 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 efficacy evaluable analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days..
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Disease Control Rate (DCR)

Analysis was performed on efficacy evaluable analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Duration of Response (DOR)

DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.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. 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 efficacy evaluable analysis set on participants who had an overall response. Here, 'Overall number of participants analyzed' = participants with available data for analysis and "0" in the overall number of participants analyzed signifies no participants with available data.

Posted

Median

95% Confidence Interval

months

From the first determination of an overall response until PD or death, whichever came first (Maximum time on study [Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months])

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Progression Free Survival (PFS)

Progression free survival was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator or death, whichever occurred first as determined from investigator derived tumor assessments per RECIST 1.1. 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 safety analysis set.

Posted

Median

95% Confidence Interval

months

Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Maximum Observed Plasma Concentration (Cmax) of Surzebiclimab

The maximum observed plasma concentration of surzebiclimab was measured in Cycle 1 and Cycle 5.

Analysis was performed on the Pharmacokinetic (PK) analysis set which included all participants who received at least 1 dose of study drug and had at least 1 derivable PK parameter for surzebiclimab. The 'Number Analyzed' = participants with available data for the specified cycle; "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliliter (mcg/mL)

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI; within 30 minutes), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI. Cycle 1 was 28 days and Cycle 5 was 21 days.

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab

Secondary

Phase 2 (Dose Expansion): Cmax of Surzebiclimab

In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5.

The analysis was performed on the PK analysis set. The Number Analyzed = participants with available data at each cycle; "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Minimum Observed Plasma Concentration (Cmin) of Surzebiclimab

Cmin of surzebiclimab was determined.

Analysis was performed on the PK analysis set. The 'Number analyzed' = participants with available data for the specified cycle and "0" signifies no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Cmin of Surzebiclimab

In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5.

The analysis was performed on the PK analysis set. The 'Number Analyzed' = participants with available data at each cycle; "0" signifies no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Surzebiclimab

Analysis was performed on the PK analysis set. The 'Number analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.

Posted

Median

Full Range

hours

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was28 days; Cycle 2 and thereafter were 21 days)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Tmax of Surzebiclimab

In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5.

The analysis was performed on the PK analysis set. The 'Number Analyzed' = participants with available data at each cycle; "0" signifies there were no participants with available data.

Posted

Median

Full Range

hours

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Half-Life (t1/2) of Surzebiclimab

Analysis was performed on the PK analysis set. 'Overall number of participants analyzed' = participants with available data for analysis and "0" signifies there were no participants with available data.

Posted

Median

Full Range

hours

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): T1/2 of Surzebiclimab

In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5.

The analysis was performed on the PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data.

Posted

Median

Full Range

hours

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: BGB A425 600 mg + Tislelizumab	Participants with HNSCC received BGB A425 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: BGB A425 600 mg + Tislelizumab	Participants with NSCLC received BGB A425 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Area Under Curve From 0 to 21 Days (AUC0-21d) of Surzebiclimab

Analysis was performed on the PK analysis set. The 'Number analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): AUC0-21d of Surzebiclimab

In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5.

The analysis was performed on the PK analysis set. The 'Number Analyzed' = participants with available data at each cycle; "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle duration= 21 days)

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Clearance (CL/F) of Surzebiclimab

Analysis was performed on the PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis and "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per hour (L/h)

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): CL/F of Surzebiclimab

In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5.

The analysis was performed on the PK analysis set. The Overall Number of Participants Analyzed = participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per hour (L/h)

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Volume of Distribution (Vz/F) of Surzebiclimab

Analysis was performed on the PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis; "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters (L)

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Vz/F of Surzebiclimab

Vz/F of surzebiclimab was determined.

In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5.

The analysis was performed on the PK analysis set. The Overall Number of Participants Analyzed = participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters (L)

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In): Cmax of Alcestobart

Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days..
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab	Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In): Cmin of Alcestobart

Cmin of alcestobart was determined.

Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days..
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab

Secondary

Phase 2 (Safety Lead-In): Tmax of Alcestobart

Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle.

Posted

Median

Full Range

hours

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab	Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In): t1/2 of Alcestobart

Analysis was performed on PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Median

Full Range

hours

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab	Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In): AUC0-21d of Alcestobart

Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*mcg/mL

Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days..
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab

Secondary

Phase 2 (Safety Lead-In): CL/F of Alcestobart

Analysis was performed on PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days..
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab	Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In): Vz/F of Alcestobart

Analysis was performed on PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab	Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Serum Concentrations of Tislelizumab

Serum concentrations of tislelizumab were measured using an enzyme-linked immunosorbent assay (ELISA).

Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified time point and "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose and EOI (within 30 minutes) on Cycle 1 Day 8 and Cycle 5 Day 1, and pre-dose on Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 25 (Cycle 1 was 28 days, Cycle 2 and thereafter were 21 days)

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
OG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab

Serum concentrations of tislelizumab were measured using an enzyme-linked immunosorbent assay (ELISA).

Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data at each time point and "0" signifies there were no participants with available data.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose on Day 1 of Cycles 1, 2, 5, 6, 9, 13, 17, 25 and at EOI (within 30 minutes) on Day 1 of Cycles 1 and 5 (each cycle was 21 days)

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG002

Secondary

Phase 1: Number of Participants With Anti-Drug Antibodies (ADA) to Surzebiclimab

Immunogenic responses to surzebiclimab included: treatment emergent, treatment-induced and treatment boosted anti-drug antibodies (ADA) and neutralizing antibody (NAb) positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration.

Analysis was performed on ADA analysis set which included all participants who received ≥ 1 dose of study drug and for whom both baseline ADA and ≥ 1 post-baseline ADA results were available. The 'Overall Number of Participants Analyzed' = participants with available data for the analysis.

Posted

Count of Participants

Participants

Maximum time on study: up to 57.5 months

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In) Cohort B: Number of Participants With Anti-Drug Antibodies to Surzebiclimab

Immunogenic responses to surzebiclimab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.

Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Count of Participants

Participants

Maximum time on study in Cohort B: up to 21.5 months

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort B: LBL-007 300 mg + Surzebiclimab + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001

Secondary

Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Surzebiclimab

Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Count of Participants

Participants

Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Alcestobart

Immunogenic responses to alcestobart included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.

Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Count of Participants

Participants

Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab

Secondary

Phase 2 (Dose Expansion) Cohorts 4 and 5: Number of Participants With Anti-Drug Antibodies to Alcestobart

Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Count of Participants

Participants

Maximum time on study: Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 1: Number of Participants With Anti-Drug Antibodies to Tislelizumab

Immunogenic responses to tislelizumab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.

Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Count of Participants

Participants

Maximum time on study: up to 57.5 months

ID	Title	Description
OG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Secondary

Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Tislelizumab

Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Count of Participants

Participants

Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months

ID	Title	Description
OG000	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
OG001	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab

Secondary

Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Tislelizumab

Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.

Posted

Count of Participants

Participants

Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Secondary

Phase 2 (Dose Expansion): Number of Participants With TEAEs and SAEs

An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.

Analysis was performed on safety analysis set.

Posted

Count of Participants

Participants

Up to 30 days after last dose of study drug (maximum treatment duration: Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months)

ID	Title	Description
OG000	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab	Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	1	1	1	1	1	1
EG001	Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab	Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	1	1	1	1	1	1
EG002	Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab	Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	0	3	3	3	3	3
EG003	Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab	Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	1	5	2	5	4	5
EG004	Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab	Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	1	7	3	7	7	7
EG005	Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab	Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	2	4	2	4	4	4
EG006	Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab	Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	1	7	1	7	7	7
EG007	Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab	Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.	1	3	0	3	3	3
EG008	Phase 1 (Dose Escalation): Surzebiclimab 60 mg	Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of cycle 1, and discontinued the study treatment. Cycle 1 consisted of 28 days.	1	1	1	1	1	1
EG009	Phase 1 (Dose Escalation): Surzebiclimab 1600 mg	Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of cycle 1, and discontinued the study treatment. Cycle 1 consisted of 28 days.	0	1	1	1	1	1
EG010	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	2	4	3	4	4	4
EG011	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	3	6	3	6	6	6
EG012	Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab	Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	2	6	4	6	6	6
EG013	Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + Surzebiclimab + Tislelizumab	Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	0	3	1	3	3	3
EG014	Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab	Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	3	6	4	6	4	6
EG015	Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab	Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	4	6	3	6	6	6
EG016	Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	15	21	9	21	20	21
EG017	Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	11	22	8	22	20	22
EG018	Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab	Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	11	20	6	20	20	20
EG019	Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab	Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.	8	20	9	20	20	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG0030 events0 affected5 at risk EG0040 events0 affected7 at risk EG0050 events0 affected4 at risk EG0060 events0 affected7 at risk EG0070 events0 affected3 at risk EG0081 events1 affected1 at risk EG0090 events0 affected1 at risk EG0100 events0 affected4 at risk EG0110 events0 affected6 at risk EG0120 events0 affected6 at risk EG0130 events0 affected3 at risk EG0141 events1 affected6 at risk EG0150 events0 affected6 at risk EG0160 events0 affected21 at risk EG0170 events0 affected22 at risk EG0180 events0 affected20 at risk EG0190 events0 affected20 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Autoimmune myocarditis	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gastric perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Malignant gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Asthenia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Disease progression	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
General physical health deterioration	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Multiple organ dysfunction syndrome	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Non-cardiac chest pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Oedema peripheral	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Catheter site infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pleural infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Psoas abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Stoma site infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Troponin I increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Troponin T increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0020 events0 affected3 at risk EG003
Immune-mediated arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Immune-mediated encephalopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0020 events0 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Laryngeal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Vocal cord dysfunction	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Capillary leak syndrome	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG0030 events0 affected5 at risk EG0040 events0 affected7 at risk EG0051 events1 affected4 at risk EG0060 events0 affected7 at risk EG0070 events0 affected3 at risk EG0080 events0 affected1 at risk EG0090 events0 affected1 at risk EG0101 events1 affected4 at risk EG0111 events1 affected6 at risk EG0120 events0 affected6 at risk EG0130 events0 affected3 at risk EG0142 events2 affected6 at risk EG0151 events1 affected6 at risk EG0169 events6 affected21 at risk EG0173 events3 affected22 at risk EG0188 events7 affected20 at risk EG0197 events6 affected20 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Splenic infarction	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Palpitations	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Autoimmune hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blepharitis	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cataract	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dry eye	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Eye pain	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Macular oedema	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Retinal exudates	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Retinal vein occlusion	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Uveitis	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Vision blurred	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Visual impairment	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Anal pruritus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Change of bowel habit	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0022 events2 affected3 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Glossitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Malignant ascites	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected1 at risk EG0011 events1 affected1 at risk EG0022 events2 affected3 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Rectal discharge	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Asthenia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Axillary pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Catheter site inflammation	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Chest pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Chills	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cyst	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Facial pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Fatigue	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0021 events1 affected3 at risk EG003
Generalised oedema	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hunger	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Localised oedema	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Nodule	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Non-cardiac chest pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Oedema peripheral	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Peripheral swelling	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Supraclavicular fossa pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Swelling	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cystitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Genital herpes simplex	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gingivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Impetigo	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lymph node abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Otitis media	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Paronychia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pilonidal disease	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Skin infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Stoma site infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Systemic viral infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Tooth infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Radiation fibrosis - lung	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Synovial rupture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Amylase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood lactic acid increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood potassium increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Blood urea increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
C-reactive protein increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Eosinophil count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Grip strength decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
International normalised ratio increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lipase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Platelet count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Thyroxine free increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Troponin I increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Troponin T increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
White blood cell count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
White blood cell count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyperalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0022 events1 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Bone swelling	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0011 events1 affected1 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Peritumoural oedema	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Tumour exudation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Ageusia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Amnesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Facial nerve disorder	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypoglossal nerve disorder	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lethargy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Sciatica	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Tension headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Delirium	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Irritability	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Urinary tract pain	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypersensitivity pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0022 events1 affected3 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0021 events1 affected3 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Collateral circulation	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hot flush	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Jugular vein distension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Phlebitis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected1 at risk EG0020 events0 affected3 at risk EG003