Study of BGB-10188 as Monotherapy, and in Combination Wit... | NCT04282018

NCT04282018

ID	Type	Description	Link
CTR20220463	Other Identifier	ChinaDrugTrials

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A: Dose Escalation- BGB-10188- 60 mg	Experimental	Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) received BGB-10188 60 milligrams (mg) orally, once daily (QD) from Cycle 1 day 1 (C1D1) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	Drug: BGB-10188
Part A: Dose Escalation- BGB-10188- 120 mg	Experimental	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	Drug: BGB-10188
Part A: Dose Escalation- BGB-10188- 240 mg	Experimental	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 240 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	Drug: BGB-10188
Part A: Dose Escalation- BGB-10188- 360 mg	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BGB-10188	Drug	Administered as specified in the treatment arm	Part A: Dose Escalation- BGB-10188- 120 mg Part A: Dose Escalation- BGB-10188- 240 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A: The Recommended Dose for Expansion (RDFE) of BGB-10188 Monotherapy in Hematologic Malignancies	The RDFE of BGB-10188 monotherapy in participants with hematologic malignancies was planned to be determined from safety, tolerability, pharmacokinetic (PK), and any other relevant and available data based on recommendations from the Safety Monitoring Committee. Part A dose-escalation enrolled participants with R/R CLL/SLL, MZL, FL, MCL, and DLBCL up to 540 mg, however the maximum tolerated dose was not reached and the RDFE could not be determined based on the data that were collected.	Up to 28 days
Part B: The RDFE of BGB-10188 in Combination With Zanubrutinib in Hematologic Malignancies	The RDFE of BGB-10188 in combination with zanubrutinib was planned to be determined from safety, tolerability, PK, and any other relevant and available data obtained, based on recommendation of the Safety Monitoring Committee. The RDFE could not be determined since not all planned dose cohorts in this part of the study were enrolled and not enough data were collected to establish the RDFE.	Up to 28 days
Part D: The RDFE of BGB-10188 in Combination With Tislelizumab in Advanced Solid Tumors	The RDFE of BGB-10188 in combination with tislelizumab was determined based on the totality of safety, tolerability, PK, and any other relevant and available data that were obtained from the dose escalation phase for Part E.	Up to 28 days
Part E: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1	ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions and no new 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.

Secondary Outcomes

Measure	Description	Time Frame
Parts A and B: ORR as Assessed by Investigator	ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions and no new 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

Eligibility Criteria

Key Inclusion Criteria:

Parts A, B and C

Confirmed diagnosis of one of the following:
- Part A: R/R CLL/SLL, R/R MZL, R/R FL, R/R MCL or R/R DLBCL
- Part B: R/R FL, R/R MCL, or R/R DLBCL
- Part C: R/R FL, R/R MCL, or R/R DLBCL
CLL = chronic lymphocytic leukemia; SLL = small lymphocytic lymphoma; MZL = marginal zone lymphoma
Participants with MZL, FL, MCL, DLBCL, or SLL must have had at least one bi-dimensionally measurable nodal lesion greater than (>) 1.5 centimeters (cm) in the longest diameter or extranodal lesion that is > 1 cm in the longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Lugano Classification.

Parts D and E
Part D: Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy (including prior chemotherapy, radiotherapy, target therapy, and immunotherapy as locally, or guidance approved therapy) or for which treatment is not available or not tolerated. Enrollment was limited to participants with advanced solid tumors for which there was clinical evidence of response to T-cell based immuno-oncology agents (e.g., non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC], head and neck squamous cell cancer, hepatocellular carcinoma, gastric or gastroesophageal junction carcinoma, nasopharyngeal carcinoma, renal cell carcinoma, cervical cancer, triple-negative breast cancer, ovarian cancer (OC), endometrial carcinoma, esophageal cancer, melanoma, urothelial carcinoma or participant with confirmed microsatellite instability-high [MSI-H] or mismatch repair deficient [dMMR] solid tumor, etc.). Enrollment of tumor types beyond above situations required sponsor's approval.
Part E: Participants with histologically or cytologically confirmed epithelial OC (including fallopian or primary peritoneal cancer) previously treated with 1 to 3 lines of systemic anticancer treatment; must have been platinum resistant and checkpoint inhibitor (CPI) naïve.
Participants must have had measurable disease as assessed by RECIST v1.1.

Key Exclusion Criteria:

Parts A, B and C

History of allogeneic stem-cell transplantation or chimeric antigen receptor-T (CAR-T) cell therapy.
For participants with DLBCL in Part A, classified as T-cell/histiocyte-rich large B-cell lymphoma, high-grade B-cell lymphoma with myelocytomatosis viral oncogene homolog and B-cell lymphoma (BCL)-2 and/or BCL-6 rearrangements, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, Epstein-Barr virus positive DLBCL, and transformed DLBCL.

Parts A, B, C, D and E
Prior exposure to PI3K inhibitor. For participants in Part B and Part C, prior exposure to BTK inhibitor and/or PI3K inhibitor.
Any approved anticancer therapy, including hormonal therapy, or any investigational agent or participation in another clinical study with therapeutic intent within 14 days before first dose.
Treatment with systemic immune-stimulatory agents (including, but not limited to, interferons and interleukin-2) within 2 weeks or 5 half-lives of the drug, whichever was later, before first dose.
Known human immunodeficiency virus (HIV) infection, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
- HBsAg (+), or
- HBcAb (+) and HBV DNA detected, or
- Presence of HCV antibody. Participants with presence of HCV antibody were eligible if HCV ribonucleic acid (RNA) was undetectable

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts/Locations Module

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Blacktown Cancer and Haematology Centre		Blacktown	New South Wales	2148	Australia
Saint Vincents Hospital Sydney

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) received BGB-10188 60 milligrams (mg) orally, once daily (QD) from Cycle 1 day 1 (C1D1) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 10, 2024	Aug 21, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 360 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Part A: Dose Escalation- BGB-10188- 360 mg

Part A: Dose Escalation- BGB-10188- 540 mg

Part A: Dose Escalation- BGB-10188- 60 mg

Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg

Part D: Dose Escalation- BGB-10188- 160 mg + Tislelizumab 200 mg

Part D: Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg

Part D: Dose Escalation- BGB-10188- 320 mg + Tislelizumab 200 mg

Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg

Part D: Dose Escalation- BGB-10188- 540 mg + Tislelizumab 200 mg

Part D: Dose Escalation- BGB-10188- 80 mg + Tislelizumab 200 mg

Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg

Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg

Analysis was performed on participants from safety analysis set that included participants who received at least one dose of BGB10188 and/or zanubrutinib and/or tislelizumab.

Arm/Group Information

ID	Title	Description
BG000	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 60 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
BG001	Part A: Dose Escalation- BGB-10188- 120 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
BG002	Part A: Dose Escalation- BGB-10188- 240 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 240 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
BG003	Part A: Dose Escalation- BGB-10188- 360 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 360 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
BG004	Part A: Dose Escalation- BGB-10188- 540 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 540 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
BG005	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, BID until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
BG006	Part D: Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
BG007	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
BG008	Part D: Dose Escalation- BGB-10188- 80 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 80 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
BG009	Part D: Dose Escalation- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days.
BG010	Part D: Dose Escalation- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
BG011	Part D: Dose Escalation- BGB-10188- 540 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 540 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days.
BG012	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
BG013	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
BG014	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
	BG00069.6± 4.04 BG00163.0± 9.38 BG00262.4± 11.99 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0011 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

Asian

Title	Measurements
	BG0001 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

Part A: The Recommended Dose for Expansion (RDFE) of BGB-10188 Monotherapy in Hematologic Malignancies

The RDFE of BGB-10188 monotherapy in participants with hematologic malignancies was planned to be determined from safety, tolerability, pharmacokinetic (PK), and any other relevant and available data based on recommendations from the Safety Monitoring Committee. Part A dose-escalation enrolled participants with R/R CLL/SLL, MZL, FL, MCL, and DLBCL up to 540 mg, however the maximum tolerated dose was not reached and the RDFE could not be determined based on the data that were collected.

Analysis was performed on safety analysis set that included all participants in Part A who received at least one dose of BGB-10188.

Posted

Number

Up to 28 days

ID	Title	Description
OG000	Part A: All Participants	All participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL who received BGB-10188 escalated doses (60 mg, 120 mg, 240 mg, 360 mg, 540 mg) orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Units	Counts
Participants	OG00034

Title

Denominators

Categories

Title	Measurements
	OG000NARDFE could not be established based on the safety, tolerability and PK data that were collected; the maximum tolerated dose was not reached

Primary

Part B: The RDFE of BGB-10188 in Combination With Zanubrutinib in Hematologic Malignancies

The RDFE of BGB-10188 in combination with zanubrutinib was planned to be determined from safety, tolerability, PK, and any other relevant and available data obtained, based on recommendation of the Safety Monitoring Committee.

The RDFE could not be determined since not all planned dose cohorts in this part of the study were enrolled and not enough data were collected to establish the RDFE.

Analysis was performed on safety analysis set that included all participants who received at least one dose of BGB-10188 and/or zanubrutinib in Part B.

Posted

Number

Up to 28 days

ID	Title	Description
OG000	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, BID until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle was of 28 days.

Units	Counts
Participants	OG000

Primary

Part D: The RDFE of BGB-10188 in Combination With Tislelizumab in Advanced Solid Tumors

The RDFE of BGB-10188 in combination with tislelizumab was determined based on the totality of safety, tolerability, PK, and any other relevant and available data that were obtained from the dose escalation phase for Part E.

Analysis was performed on safety analysis set.

Posted

Number

milligram (mg)

Up to 28 days

ID	Title	Description
OG000	Part D: All Participants	All participants with unresectable locally advanced or metastatic solid tumors who received BGB-10188 escalated doses (20 mg, 40 mg, 80 mg, 160 mg, 320 mg, 540 mg) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Units	Counts
Participants	OG000

Primary

Part E: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis was performed on the efficacy analysis set that included all participants who received at least one dose of BGB 10188 and /or tislelizumab on or after Cycle 1 Day 1.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 10.0 months

ID	Title	Description
OG000	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
OG001	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.

Primary

Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

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. 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

Part A: 47.2 Months; Part B: 24 Months; Part D: 15.2 Months; Part E: 10 Months

ID	Title	Description
OG000	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 60 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG001	Part A: Dose Escalation- BGB-10188- 120 mg

Secondary

Parts A and B: ORR as Assessed by Investigator

ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions and no new 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 participants in the efficacy analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Part A: up to 47.2 months and Part B: up to 24 months

ID	Title	Description
OG000	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 60 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG001	Part A: Dose Escalation- BGB-10188- 120 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Secondary

Part A: Observed Maximum Plasma Concentration (Cmax) of BGB-10188 After a Single Dose

Cmax of BGB-10188 after a single dose was determined.

Analysis was performed on the PK analysis set that included all participants who had >= 1 post-dose plasma concentration and no major protocol deviation affecting PK.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms per milliliter (ng/mL)

Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 168 hours post-dose on Day -7 (each cycle = 28 days)

ID	Title	Description
OG000	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 60 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG001	Part A: Dose Escalation- BGB-10188- 120 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG002

Secondary

Part A: Cmax of BGB-10188 at Steady State

Cmax of BGB-10188 at steady state was determined.

Analysis was performed on participants in the PK analysis set. Here, 'overall number of participants analyzed' = participants with available data for the analysis of Cmax.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms per milliliter (ng/mL)

Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 15 (each cycle = 28 days)

ID	Title	Description
OG000	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 60 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG001	Part A: Dose Escalation- BGB-10188- 120 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG002	Part A: Dose Escalation- BGB-10188- 240 mg

Secondary

Part A: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) After Single Dose

Area under the plasma concentration-time curve of BGB-10188 from time 0 to 24 hours (AUC0-24) was determined.

Analysis was performed on participants in the PK analysis set.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*ng/mL

Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8,12, and 24 hours post-dose on Day-7 (each cycle = 28 days)

ID	Title	Description
OG000	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 60 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG001	Part A: Dose Escalation- BGB-10188- 120 mg	Participants with R/R CLL/SLL, MZL, FL, MCL or DLBCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.
OG002	Part A: Dose Escalation- BGB-10188- 240 mg

Secondary

Part B: 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 (PD) or death, whichever came first. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new 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 the efficacy analysis set. Participants with the best overall response of complete response or partial response were included in the analysis.

Posted

Median

95% Confidence Interval

months

Up to 24 months

ID	Title	Description
OG000	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, BID until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Secondary

Part B: Time to Response (TTR)

TRR was defined as the time from treatment initiation to the first documentation of response. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have a 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 the efficacy analysis set. Participants with the best overall response of complete response or partial response were included in the analysis.

Posted

Median

Full Range

months

Up to 24 months

ID	Title	Description
OG000	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, BID until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Units	Counts
Participants

Secondary

Part B: Cmax of BGB-10188 After a Single Dose

Cmax of BGB-10188 after a single dose when given in combination with zanubrutinib was determined.

Analysis was performed on the PK analysis set.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose, 0.5,1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)

ID	Title	Description
OG000	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, twice a day (BID) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Units	Counts
Participants	OG000

Secondary

Part B: Cmax of BGB-10188 at Steady State

Cmax of BGB-10188 at steady state when given in combination with zanubrutinib was determined.

Analysis was performed on the PK analysis set.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 15 (each cycle = 28 days)

ID	Title	Description
OG000	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, BID until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Units	Counts
Participants	OG000

Secondary

Part B: AUC 0-24 h of BGB-10188 After a Single Dose

AUC 0-24 h of BGB-10188 after a single dose when given in combination with zanubrutinib was determined.

Analysis was performed on the PK analysis set.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*ng/mL

Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)

ID	Title	Description
OG000	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, BID until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.

Units	Counts
Participants	OG000

Secondary

Part D: Overall Response Rate (ORR)

ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new 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 the efficacy analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 15.2 months

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
OG001	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Secondary

Parts D and E: 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 PD or death, whichever came first. Median DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new 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 in the study. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment.

Analysis was performed on participants in the efficacy analysis set with an objective response. Here, "zero" in the overall number of participants analyzed signifies that there were no responders in the specified groups.

Posted

Median

95% Confidence Interval

months

Part D: up to 15.2 months and Part E: up to 10.0 months

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Secondary

Parts D and E: Disease Control Rate (DCR)

DCR was defined as the percentage of participants with best overall response (BOR), as per RECIST v.1.1, of a CR, PR, or stable disease (SD). Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new 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 PD, taking as reference the smallest sum diameters while on study.

Analysis was performed on participants in the efficacy analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Part D: up to 15.2 months and Part E: up to 10.0 months

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
OG001	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg

Secondary

Parts D and E: Time to Response (TTR)

TTR was defined as the time from treatment initiation to the first documentation of response. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new lesions. Any pathological lymph nodes (whether target or non-target) must have a 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.

Posted

Median

Inter-Quartile Range

months

Part D: up to 15.2 months and Part E: up to 10.0 months

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
OG001	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg

Secondary

Part D: Cmax of BGB-10188 After a Single Dose

Cmax of BGB-10188 after a single dose when given in combination with tislelizumab was determined.

Analysis was performed on participants in the PK analysis set. Here, 'overall number of participants analyzed' = participants with available data for the analysis of Cmax.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
OG001	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Secondary

Part D: Cmax of BGB-10188 at Steady State

Cmax of BGB-10188 at steady state when given in combination with tislelizumab was determined.

Analysis was performed on participants in the PK analysis set. Here, 'overall number of participants analyzed' = participants with available data for the analysis of Cmax.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
OG001	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Secondary

Part D: AUC 0-24h of BGB-10188 After Single Dose

AUC 0-24 h of BGB-10188 after a single dose when given in combination with tislelizumab was determined.

Analysis was performed on participants in the PK analysis set. Here, 'overall number of participants analyzed' = participants with available data for the analysis of AUC0-24h.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*ng/mL

Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 1 Day 1 (each cycle = 28 days)

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
OG001	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Secondary

Part D: AUC 0-24h of BGB-10188 at Steady State

AUC 0-24 h of BGB-10188 at steady state when given in combination with tislelizumab was determined.

Analysis was performed on participants in the PK analysis set. Here, 'overall number of participants analyzed' = participants with available data for the analysis of AUC0-24h.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*ng/mL

Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)

ID	Title	Description
OG000	Part D : Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg (initial dose) orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.
OG001	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Secondary

Part E: Progression-Free Survival (PFS)

PFS was defined as the time from the date of the first dose of study drugs to the date of the first documentation of PD assessed by the investigator using RECIST v1.1 or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Analysis was performed on participants in the efficacy analysis set.

Posted

Median

95% Confidence Interval

months

Up to 10.0 months

ID	Title	Description
OG000	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
OG001	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.

Secondary

Part E: Clinical Benefit Rate (CBR)

CBR was defined as the percentage of participants with best overall response, as defined by RECIST v1.1, of a CR, PR, or at least 24 weeks of SD. Per RECIST v.1.1., CR was defined as disappearance of all target lesions, non-target lesions, and no new 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 PD, taking as reference the smallest sum diameters while on study.

Analysis was performed on participants in the efficacy analysis set.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 10.0 months

ID	Title	Description
OG000	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
OG001	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.

Secondary

Part E: Cancer Antigen (CA)-125 Response Rate Per Gynecological Cancer Intergroup

CA-125 response rate was defined as the percentage of participants achieving a CA-125 response according to the Gynecological Cancer Center Intergroup criteria, in which a response had occurred if there was at least a 50% reduction in CA-125 levels from baseline.

Analysis was performed on participants in the efficacy evaluable set with an evaluable CA-125 at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 10.0 months

ID	Title	Description
OG000	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
OG001	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.

Secondary

Part E: Cmax of BGB-10188 After Single Dose

Cmax of BGB-10188 after a single dose when given in combination with tislelizumab was determined.

Analysis was performed on participants in the PK analysis set.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 1 (each cycle = 21 days)

ID	Title	Description
OG000	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
OG001	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.

Secondary

Part E: Cmax of BGB-10188 at Steady State

Cmax of BGB-10188 at steady state when given in combination with tislelizumab was determined.

Analysis was performed on participants in the PK analysis set. Here, 'overall number of participants analyzed' = participants with available data for the analysis of Cmax.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 2 Day 1 (each cycle = 21 days)

ID	Title	Description
OG000	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
OG001	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.

Secondary

Part E: AUC0-24h of BGB-10188 After Single Dose

AUC0-24 h of BGB-10188 after a single dose when given in combination with tislelizumab was determined.

Analysis was performed on participants in the PK analysis set. Here, 'overall number of participants analyzed' = participants with available data for the analysis of AUC0-24h.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*ng/mL

Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose of Cycle 1 Day 1 (each cycle = 21 days)

ID	Title	Description
OG000	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.
OG001	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. 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	Part A: Dose Escalation- BGB-10188- 60 mg	Participants with R/R CLL/SLL, MZL, FL, or MCL received BGB-10188 60 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	1	5	1	5	4	5
EG001	Part A: Dose Escalation- BGB-10188- 120 mg	Participants with R/R CLL/SLL, MZL, FL, or MCL received BGB-10188 120 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	1	5	1	5	5	5
EG002	Part A: Dose Escalation- BGB-10188- 240 mg	Participants with R/R CLL/SLL, MZL, FL, or MCL received BGB-10188 240 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	1	8	3	8	8	8
EG003	Part A: Dose Escalation- BGB-10188- 360 mg	Participants with R/R CLL/SLL, MZL, FL, or MCL received BGB-10188 360 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	0	6	1	6	6	6
EG004	Part A: Dose Escalation- BGB-10188- 540 mg	Participants with R/R CLL/SLL, MZL, FL, or MCL received BGB-10188 540 mg orally, QD from C1D1 until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	0	10	4	10	10	10
EG005	Part B: Dose Escalation- BGB-10188- 240 mg + Zanubrutinib-160 mg	Participants with R/R FL, MCL, and DLBCL received BGB-10188 240 mg orally, QD from C1D1 in combination with zanubrutinib 160 mg orally, twice a day (BID) until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 28 days.	0	4	2	4	4	4
EG006	Part D: Dose Escalation- BGB-10188- 20 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 20 mg orally, QD from C1D1, followed by tislelizumab 200 mg intravenously (IV) on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.	0	5	1	5	5	5
EG007	Part D: Dose Escalation- BGB-10188- 40 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.	1	5	3	5	5	5
EG008	Part D: Dose Escalation- BGB-10188- 80 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 80 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.	3	6	4	6	6	6
EG009	Part D: Dose Escalation- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days.	2	11	5	11	11	11
EG010	Part D: Dose Escalation- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.	1	10	5	10	9	10
EG011	Part D: Dose Escalation- BGB-10188- 540 mg + Tislelizumab 200 mg	Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 540 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days, and the duration of each cycle from Cycle 2 onwards was 21 days.	0	7	2	7	7	7
EG012	Part E: Dose Expansion- BGB-10188- 160 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 160 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.	2	9	4	9	8	9
EG013	Part E: Dose Expansion- BGB-10188- 320 mg + Tislelizumab 200 mg	Participants with PROC were randomized to receive BGB-10188 320 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on Day 1 of each cycle until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. Each cycle consisted of 21 days.	1	5	2	5	5	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG0030 events0 affected6 at risk EG0040 events0 affected10 at risk EG0050 events0 affected4 at risk EG0060 events0 affected5 at risk EG0070 events0 affected5 at risk EG0080 events0 affected6 at risk EG0090 events0 affected11 at risk EG0100 events0 affected10 at risk EG0110 events0 affected7 at risk EG0120 events0 affected9 at risk EG0130 events0 affected5 at risk
Acute myocardial infarction	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Immune-mediated myocarditis	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Ascites	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Colitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Constipation	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Enterocolitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Nausea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Stomatitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
General physical health deterioration	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pain	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pyrexia	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
COVID-19	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
COVID-19 pneumonia	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Cytomegalovirus infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Herpes zoster	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Large intestine infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Neutropenic sepsis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pneumonia	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pulmonary sepsis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Aspartate aminotransferase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Immune-mediated arthritis	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dizziness	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Haemorrhage intracranial	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Spinal cord compression	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Syncope	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Anxiety	Psychiatric disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0025 events4 affected8 at risk EG0034 events3 affected6 at risk EG0041 events1 affected10 at risk EG0050 events0 affected4 at risk EG0061 events1 affected5 at risk EG0072 events2 affected5 at risk EG0082 events1 affected6 at risk EG0092 events2 affected11 at risk EG0102 events2 affected10 at risk EG0111 events1 affected7 at risk EG0125 events4 affected9 at risk EG0131 events1 affected5 at risk
Coagulopathy	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Leukopenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Methaemoglobinaemia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Neutropenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected5 at risk EG0022 events2 affected8 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Angina pectoris	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Cardiac failure	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Palpitations	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Sinus bradycardia	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Sinus tachycardia	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Ventricular extrasystoles	Cardiac disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Ear congestion	Ear and labyrinth disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Ear pain	Ear and labyrinth disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hyperthyroidism	Endocrine disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypophysitis	Endocrine disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypothyroidism	Endocrine disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Eye haemorrhage	Eye disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Eye pruritus	Eye disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Periorbital dermatitis	Eye disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Photophobia	Eye disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Retinal detachment	Eye disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Scleral haemorrhage	Eye disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Vision blurred	Eye disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Abdominal distension	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events1 affected8 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Anal fissure	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Anorectal discomfort	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Ascites	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Chronic gastritis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Colitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Constipation	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected5 at risk EG0021 events1 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0003 events3 affected5 at risk EG0012 events2 affected5 at risk EG0020 events0 affected8 at risk EG003
Dry mouth	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dyspepsia	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Enterocolitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Eructation	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Flatulence	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Gingival bleeding	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Gingival pain	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Intestinal polyp	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Lip ulceration	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Mouth ulceration	Gastrointestinal disorders	26.0	Systematic Assessment	EG0004 events1 affected5 at risk EG0011 events1 affected5 at risk EG0023 events2 affected8 at risk EG003
Nausea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0005 events2 affected5 at risk EG0012 events2 affected5 at risk EG0022 events2 affected8 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Overflow diarrhoea	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pancreatitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Salivary gland pain	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Stomatitis	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Tongue ulceration	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Toothache	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0023 events2 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Axillary pain	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Chest discomfort	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Chest pain	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Chills	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Cyst	General disorders and administration site conditions	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Face oedema	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Facial pain	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Fatigue	General disorders and administration site conditions	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0013 events3 affected5 at risk EG0023 events3 affected8 at risk EG003
General physical health deterioration	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Influenza like illness	General disorders and administration site conditions	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Localised oedema	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Malaise	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Non-cardiac chest pain	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Oedema peripheral	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Pain	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Peripheral swelling	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pyrexia	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events1 affected8 at risk EG003
Sensation of foreign body	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Suprapubic pain	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Thirst	General disorders and administration site conditions	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0021 events1 affected8 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Drug hypersensitivity	Immune system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Food allergy	Immune system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Acute sinusitis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Bronchitis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
COVID-19	Infections and infestations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected5 at risk EG0021 events1 affected8 at risk EG003
Cellulitis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Conjunctivitis	Infections and infestations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Cytomegalovirus infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Cytomegalovirus infection reactivation	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Diverticulitis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Fungal skin infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Gastroenteritis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Gastrointestinal infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Herpes zoster	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Influenza	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0023 events2 affected8 at risk EG003
Lower respiratory tract infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Nail bed infection bacterial	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Nasopharyngitis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Onychomycosis	Infections and infestations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Oral candidiasis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Otitis externa	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Otitis media	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Paronychia	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Parotitis	Infections and infestations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pharyngitis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pneumonia	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Sinusitis	Infections and infestations	26.0	Systematic Assessment	EG0002 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Skin candida	Infections and infestations	26.0	Systematic Assessment	EG0002 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Staphylococcal skin infection	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Systemic viral infection	Infections and infestations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	26.0	Systematic Assessment	EG0007 events1 affected5 at risk EG0014 events3 affected5 at risk EG0024 events2 affected8 at risk EG003
Urinary tract infection	Infections and infestations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected5 at risk EG0021 events1 affected8 at risk EG003
Urinary tract infection bacterial	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Contusion	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Fall	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Immunisation reaction	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0015 events2 affected5 at risk EG0020 events0 affected8 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Sunburn	Injury, poisoning and procedural complications	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Alpha hydroxybutyrate dehydrogenase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Amylase decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Amylase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Aspartate aminotransferase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Beta 2 microglobulin increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Blood alkaline phosphatase increased	Investigations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Blood bilirubin increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood cholesterol increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood creatine phosphokinase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood creatinine increased	Investigations	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Blood fibrinogen decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood fibrinogen increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood glucose increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood immunoglobulin M increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Blood lactate dehydrogenase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
C-reactive protein increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Cytomegalovirus test positive	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events1 affected8 at risk EG003
Electrocardiogram QT prolonged	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Eosinophil count increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Gamma-glutamyltransferase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Immunoglobulins decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Light chain analysis increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Lipase increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Liver function test abnormal	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Lymphocyte count decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Neutrophil count decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Platelet count decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events1 affected8 at risk EG003
Protein urine present	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
SARS-CoV-2 test positive	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0021 events1 affected8 at risk EG003
Troponin increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Vitamin K decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Weight decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Weight increased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
White blood cell count decreased	Investigations	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dehydration	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events1 affected8 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Hypophagia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Polydipsia	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Coccydynia	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Muscle discomfort	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0022 events1 affected8 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected5 at risk EG0020 events0 affected8 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Shoulder girdle pain	Musculoskeletal and connective tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Amnesia	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dizziness	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dizziness postural	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0023 events1 affected8 at risk EG003
Dysgeusia	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0023 events1 affected8 at risk EG003
Headache	Nervous system disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypersomnia	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypoaesthesia	Nervous system disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Lethargy	Nervous system disorders	26.0	Systematic Assessment	EG0005 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Loss of consciousness	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Memory impairment	Nervous system disorders	26.0	Systematic Assessment	EG0002 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Migraine	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events1 affected8 at risk EG003
Neuralgia	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Paraesthesia	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Parosmia	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Taste disorder	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Tension headache	Nervous system disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Anxiety	Psychiatric disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Confusional state	Psychiatric disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Depression	Psychiatric disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Insomnia	Psychiatric disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0022 events2 affected8 at risk EG003
Libido decreased	Psychiatric disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Acute kidney injury	Renal and urinary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Albuminuria	Renal and urinary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Glycosuria	Renal and urinary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Haematuria	Renal and urinary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Polyuria	Renal and urinary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Proteinuria	Renal and urinary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Urinary incontinence	Renal and urinary disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Breast tenderness	Reproductive system and breast disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Oedema genital	Reproductive system and breast disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0012 events1 affected5 at risk EG0022 events2 affected8 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Sinonasal obstruction	Respiratory, thoracic and mediastinal disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Exfoliative rash	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0012 events2 affected5 at risk EG0020 events0 affected8 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Rash	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0002 events2 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0021 events1 affected8 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0012 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events1 affected8 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Deep vein thrombosis	Vascular disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Flushing	Vascular disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0022 events2 affected8 at risk EG003
Hot flush	Vascular disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0011 events1 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypertension	Vascular disorders	26.0	Systematic Assessment	EG0001 events1 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Hypotension	Vascular disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003
Superficial vein thrombosis	Vascular disorders	26.0	Systematic Assessment	EG0000 events0 affected5 at risk EG0010 events0 affected5 at risk EG0020 events0 affected8 at risk EG003

Part C was cancelled by the sponsor and not initiated.

Certain Agreements

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D008224	Lymphoma, Follicular
D018442	Lymphoma, B-Cell, Marginal Zone
D020522	Lymphoma, Mantle-Cell
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D016393	Lymphoma, B-Cell

ID	Term
C000629551	zanubrutinib
C000707970	tislelizumab

Participants with unresectable locally advanced or metastatic solid tumors received BGB-10188 40 mg orally, QD from C1D1, followed by tislelizumab 200 mg IV on C1D8 and Day 1 of all subsequent cycles until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow-up, end of study, investigator's decision, or termination of the study by the sponsor, whichever occurred first. The duration of Cycle 1 was 28 days and the duration of each cycle from Cycle 2 onwards was 21 days.

Units	Counts
Participants	OG0009 OG0015

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0121 events1 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0091 events1 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0092 events1 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0111 events1 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0121 events1 affected9 at risk

EG0131 events1 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0111 events1 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0121 events1 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0121 events1 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0101 events1 affected10 at risk

EG0110 events0 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0092 events1 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0081 events1 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0041 events1 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0080 events0 affected6 at risk

EG0090 events0 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0120 events0 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk

EG0070 events0 affected5 at risk

EG0081 events1 affected6 at risk

EG0091 events1 affected11 at risk

EG0100 events0 affected10 at risk

EG0110 events0 affected7 at risk

EG0121 events1 affected9 at risk

EG0130 events0 affected5 at risk

EG0040 events0 affected10 at risk

EG0050 events0 affected4 at risk

EG0060 events0 affected5 at risk