A First Time in Human (FTIH) Study of GSK3745417 Administ... | NCT03843359

NCT03843359

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 1A: Participants receiving GSK3745417, Dose-escalation Cohort	Experimental		Drug: GSK3745417
Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort	Experimental		Drug: GSK3745417 Drug: Dostarlimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK3745417	Drug	GSK3745417 will be administered.	Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)	AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0	Up to 21 Days
Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)	AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0	Up to 29 Days
Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Secondary Outcomes

Measure	Description	Time Frame
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)	Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.	Pre-dose on weeks(W) 1-6,9,10,12,19,55;end of infusion(EOI)+5minute(min) on W 1-6, 9,10,12,19,55;EOI+4 hour(HR)/8 HR on W 1-6, 9, 10, 12, 19;EOI+15min/30min/45min/1HR on W 1-6, 9,12;EOI+24HR on W 1-6, 9,10,12; EOI+2HR on W 1-6,9,10,12,19,55

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must be more than or equal to (>=)18 years of age.
Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
Histological or cytological documentation of an advanced solid tumor.
Participants must provide a fresh biopsy.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Adequate organ function per protocol specifications.
Male or female participants.
Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception.
Capable of giving signed informed consent.

Exclusion Criteria:

Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years.
Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment.
Current unstable liver or biliary disease.
History of vasculitis at any time prior to study treatment.
Evidence or history of significant active bleeding or coagulation disorder.
Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C.
QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (>)450 milliseconds (msec) or QTcF >480 msec for participants with bundle branch block.
Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
History or evidence of cardiovascular (CV) risk
Recent (within the past 6 months) history of symptomatic pericarditis.
History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.
History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
Prior treatment with the following agents:
1. Stimulator of Interferon Genes (STING) agonist at any time.
2. Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter.
3. Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days.
4. Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented.
Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed.
Receipt of any live vaccine within 30 days of the start of study treatment.
Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
Major surgery less than or equal to (<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry.
Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Houston	Texas	77030	United States
GSK Investigational Site

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 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

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	Aug 4, 2023	Apr 3, 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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Part 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG001	Part 1A: GSK3745417 0.2 mg (Q3W)	Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG002	Part 1A: GSK3745417 0.1 mg (Q1W)	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG003	Part 1A: Japan GSK3745417 0.1 mg (Q1W)	Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG004	Part 1A: GSK3745417 0.2 mg (Q1W)	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG005	Part 1A: GSK3745417 0.4 mg (Q1W)	Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG006	Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis	Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG007	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG008	Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG009	Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG010	Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine ([18F]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
BG011	Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
BG012	Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of [18F]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.
BG013	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
	BG00050.0± 1.73 BG00146.8± 17.81 BG00255.8± 11.44 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)

AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0

DLT Evaluable population included All Treated population who completed at least 21 days of DLT period or discontinued from treatment within 21 days due to an AE meeting the definition of a DLT.

Posted

Count of Participants

Participants

Up to 21 Days

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q1W)	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: Japan GSK3745417 0.1 mg (Q1W)	Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG002	Part 1A: GSK3745417 0.2 mg (Q1W)	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG003	Part 1A: GSK3745417 0.4 mg (Q1W)	Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Units	Counts
Participants	OG0004 OG0012 OG0029 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)

DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.

Posted

Count of Participants

Participants

Up to 29 Days

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Primary

Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.

Posted

Count of Participants

Participants

Up to 29 Days

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Primary

Parts 2A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.

Posted

Count of Participants

Participants

Up to 29 Days

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Primary

Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity

AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to National Cancer Institute Common Terminology Criteria for AE (NCI-CTCAE) (version 5.0):G1=Mild,G2=Moderate,G3=Severe or medically significant but not immediately life-threatening,G4=Life-threatening consequences,G5=Death related AE.

All treated population included all participants who received at least one dose of GSK3745417. Each participant was counted only once, based on the highest grade they experienced across all adverse events.

Posted

Count of Participants

Participants

Up to approximately 62 weeks

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Primary

Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity

AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.

All treated population. Each participant was counted only once, based on the highest grade they experienced across all adverse events.

Posted

Count of Participants

Participants

Up to approximately 93 weeks

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Primary

Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity

AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.

All treated population. Each participant was counted only once, based on the highest grade they experienced across all adverse events.

Posted

Count of Participants

Participants

Up to 30.3 weeks

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.

Secondary

Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population included all participants from the All Treated Population for whom at least one PK sample was obtained and analyzed. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Median

Full Range

Nanogram/ millilitre (ng/mL)

Pre-dose on weeks(W) 1-6,9,10,12,19,55;end of infusion(EOI)+5minute(min) on W 1-6, 9,10,12,19,55;EOI+4 hour(HR)/8 HR on W 1-6, 9, 10, 12, 19;EOI+15min/30min/45min/1HR on W 1-6, 9,12;EOI+24HR on W 1-6, 9,10,12; EOI+2HR on W 1-6,9,10,12,19,55

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q1W)	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: Japan GSK3745417 0.1 mg (Q1W)	Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*Nanogram/ millilitre (h*ng/mL)

Week 1 to 6, 9, 10, 12, 19

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q1W)	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: Japan GSK3745417 0.1 mg (Q1W)	Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG002	Part 1A: GSK3745417 0.2 mg (Q1W)

Secondary

Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Week 1 to 6, 9, 10, 12, 19

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q1W)	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: Japan GSK3745417 0.1 mg (Q1W)	Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG002	Part 1A: GSK3745417 0.2 mg (Q1W)

Secondary

Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Week 1 to 6, 9, 10, 12, 19

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q1W)	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: Japan GSK3745417 0.1 mg (Q1W)	Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG002	Part 1A: GSK3745417 0.2 mg (Q1W)

Secondary

Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Median

Full Range

Nanogram/ millilitre (ng/mL)

Pre-dose on W 1, 4, 7, 10, 13, 16, 19; EOI+5min/ 15min/ 30 min/ 45 min/1HR/ 2HR/ 4HR on W 1, 4, 7, 10, 13, 16, 19; EOI+8HR/ 24HR on W 1, 4, 7, 10, 13, 16

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: GSK3745417 0.2 mg (Q3W)	Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*Nanogram/ millilitre (h*ng/mL)

Week 1, 4, 7, 10, 13, 16, 19

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: GSK3745417 0.2 mg (Q3W)	Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Week 1, 4, 7, 10, 13, 16, 19

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: GSK3745417 0.2 mg (Q3W)	Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Units

Secondary

Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Week 1, 4, 7, 10, 13, 16, 19

ID	Title	Description
OG000	Part 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 1A: GSK3745417 0.2 mg (Q3W)	Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Units

Secondary

Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Median

Full Range

ng/mL

Pre-dose,EOI+5min/2HR/4HR on W 1 to 5, 7, 10, 13, 19, 37, 55; EOI+15min/ 30min/ 45 min/ 1HR on W 1, 4, 7; EOI+8HR on W 1 to 5, 7, 10, 13, 19; EOI+24HR on W 1 to 5, 7, 10

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Week 1 to 5, 7, 10, 13, 19

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Week 1 to 5, 7, 10, 13, 19

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Week 1 to 5, 7, 10, 13, 19

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Median

Full Range

ng/mL

Pre-dose and EOI+5min/ 2HR/ 4HR on W 1, 2, 5, 6, 8, 11, 14, 20, 38; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1 and 8; EOI+8HR in W 1, 2, 5, 6, 8; EOI+24HR on W 1, 2, 5, 8.

ID	Title	Description
OG000	Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine ([18F]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
OG001	Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of [18F]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.

Secondary

Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Week 1, 2, 5, 6, 8

ID	Title	Description
OG000	Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine ([18F]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
OG001	Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of [18F]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.

Secondary

Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Week 1, 2, 5, 6, 8

ID	Title	Description
OG000	Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine ([18F]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
OG001	Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of [18F]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.

Secondary

Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Week 1, 2, 5, 6, 8

ID	Title	Description
OG000	Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine ([18F]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.
OG001	Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of [18F]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.

Secondary

Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Median

Full Range

ng/mL

Pre-dose on W 1, 4, 7, 10, 13, 19, 37, 55, 73, 91; EOI+5min/ 4HR on W 1, 4, 7, 10, 13, 19, 37, 55, 91; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1, 4, 7; EOI+2HR on W 1, 4, 7, 10, 13, 19, 37, 55, 73; EOI+8HR/24 HR on W 1, 4, 7, 10, 13, 19, 91

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Week 1, 4, 7, 10, 13, 19, 91

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Week 1, 4, 7, 10, 13, 19, 91

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Week 1, 4, 7, 10, 13, 19, 91

ID	Title	Description
OG000	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.
OG001	Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Secondary

Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Median

Full Range

ng/mL

Pre-dose and EOI+5min/2HR/ 4HR/ 8HR on crossover W 1, 4, 7, 10, 13, 19; EOI+12HR/18HR on crossover W 4; EOI+15min/ 30 min/45 min/1HR/6HR/24HR on crossover W 1, 4, 7

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
OG001	Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.

Secondary

Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Crossover Week 1, 4, 7, 10, 13, 19

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
OG001	Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.

Secondary

Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Crossover Week 1, 4, 7, 10, 13, 19

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
OG001	Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.

Secondary

Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Crossover Week 1, 4, 7, 10, 13, 19

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.
OG001	Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.

Secondary

Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Median

Full Range

ng/mL

Pre-dose and EOI+5min/ 2HR/4HR on crossover W 1-4, 7,10,19; EOI+15min/30 min/45 min/1HR/ 6HR/ 24HR on crossover W 1,4,7;EOI+12HR/18HR on crossover W 4;EOI+8HR on crossover W 1-4,7,10

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.

Units	Counts
Participants	OG000

Secondary

Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Crossover Week 1, 2, 3, 4, 5, 7, 10

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.

Units	Counts
Participants	OG000

Secondary

Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Crossover Week 1, 2, 3, 4, 5, 7, 10

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.

Units	Counts
Participants	OG000

Secondary

Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.

Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Crossover Week 1, 2, 3, 4, 5, 7, 10

ID	Title	Description
OG000	Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.

Units	Counts
Participants	OG000

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 1A: GSK3745417 0.1 mg (Q3W)	Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	3	3	0	3	2	3
EG001	Part 1A: GSK3745417 0.2 mg (Q3W)	Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	5	6	0	6	5	6
EG002	Part 1A: GSK3745417 0.1 mg (Q1W)	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	6	14	4	14	14	14
EG003	Part 1A: Japan GSK3745417 0.1 mg (Q1W)	Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	0	2	0	2	2	2
EG004	Part 1A: GSK3745417 0.2 mg (Q1W)	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	14	19	7	19	19	19
EG005	Part 1A: GSK3745417 0.4 mg (Q1W)	Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	7	10	3	10	10	10
EG006	Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis	Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	8	9	2	9	9	9
EG007	Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	3	4	1	4	4	4
EG008	Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	8	12	6	12	12	12
EG009	Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	4	4	3	4	4	4
EG010	Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine ([18F]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed.	2	3	2	3	3	3
EG011	Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.	8	10	4	10	10	10
EG012	Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab	Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of [18F]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed.	0	1	1	1	1	1
EG013	Crossover: GSK3745417 0.1 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV every 6 weeks (Q6W) until 30.3 weeks.	0	1	0	1	1	1
EG014	Crossover: GSK3745417 0.2 mg (Q3W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W, followed by 1000 mg IV Q6W until 30.3 weeks.	1	4	1	4	3	4
EG015	Crossover: GSK3745417 0.1 mg (Q1W) + Dostarlimab	Participants with advanced solid tumors who received GSK3745417 monotherapy in Part 1A, upon disease progression, crossed over and received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W followed by 1000 mg IV Q6W until 30.3 weeks.	2	5	1	5	5	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG0030 events0 affected2 at risk EG0040 events0 affected19 at risk EG0051 events1 affected10 at risk EG0060 events0 affected9 at risk EG0070 events0 affected4 at risk EG0080 events0 affected12 at risk EG0090 events0 affected4 at risk EG0100 events0 affected3 at risk EG0110 events0 affected10 at risk EG0120 events0 affected1 at risk EG0130 events0 affected1 at risk EG0140 events0 affected4 at risk EG0150 events0 affected5 at risk
Cardiac failure	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Myopericarditis	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Infusion site extravasation	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pyrexia	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Portal vein stenosis	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Abdominal infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Cellulitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Device related bacteraemia	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Device related sepsis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Sepsis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Vascular device infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Headache	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Monoparesis	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Immune-mediated cystitis	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Haemorrhage	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypotension	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG00210 events7 affected14 at risk EG0030 events0 affected2 at risk EG00410 events4 affected19 at risk EG00510 events3 affected10 at risk EG0068 events5 affected9 at risk EG0070 events0 affected4 at risk EG0083 events2 affected12 at risk EG0090 events0 affected4 at risk EG0107 events2 affected3 at risk EG0113 events3 affected10 at risk EG0123 events1 affected1 at risk EG0130 events0 affected1 at risk EG0140 events0 affected4 at risk EG0152 events1 affected5 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected14 at risk EG003
Splenic infarction	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Bradycardia	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Palpitations	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pericarditis	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Tachycardia	Cardiac disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Ear congestion	Ear and labyrinth disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Glaucoma	Eye disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Lacrimation increased	Eye disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Photophobia	Eye disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected14 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0024 events4 affected14 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0027 events4 affected14 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected6 at risk EG0023 events3 affected14 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events2 affected14 at risk EG003
Application site irritation	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Asthenia	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Catheter site erythema	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Catheter site oedema	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Chest discomfort	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Chest pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Chills	General disorders	MedDRA v26.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0015 events3 affected6 at risk EG0026 events4 affected14 at risk EG003
Device related thrombosis	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Face oedema	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Facial pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Fatigue	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0027 events6 affected14 at risk EG003
Inflammation	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Infusion site extravasation	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Injection site reaction	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected14 at risk EG003
Malaise	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Oedema peripheral	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pyrexia	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0018 events4 affected6 at risk EG00211 events4 affected14 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hepatobiliary disease	Hepatobiliary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected6 at risk EG0020 events0 affected14 at risk EG003
Bacteraemia	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
COVID-19	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Cellulitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Device related bacteraemia	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Device related infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Influenza	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Skin infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Tinea infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Skin injury	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Stress fracture	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events2 affected14 at risk EG003
Blood albumin decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0023 events1 affected14 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Blood bilirubin increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Blood creatinine increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Blood pressure decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Blood pressure increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected14 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Lipase increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Neutrophil count increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Platelet count decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Respiratory rate increased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Weight decreased	Investigations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected14 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected14 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Dizziness	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Facial nerve disorder	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Headache	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events1 affected6 at risk EG0025 events3 affected14 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Neuralgia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Presyncope	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Somnolence	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Syncope	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Depression	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hallucination	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Urethral pain	Renal and urinary disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events2 affected14 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Oropharyngeal fistula	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected14 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Pleurodesis	Surgical and medical procedures	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Embolism	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypertension	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected14 at risk EG003
Hypotension	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected14 at risk EG003
Phlebitis	Vascular disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected14 at risk EG003

ID	Term
D009369	Neoplasms
D001733	Bites and Stings

ID	Term
C000719628	dostarlimab

FG0142 subjects1 participant completed follow-up and 1 participant died

FG0152 subjects2 participants died

BG012NA± NANo data was reported to maintain participant (0\<n\<2) confidentiality and privacy.

Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier.

Units	Counts
Participants	OG0003 OG0016

Units	Counts
Participants	OG0001 OG0014

EG0041 events1 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0052 events1 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0111 events1 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0112 events1 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0081 events1 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0041 events1 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0081 events1 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0041 events1 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0111 events1 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0080 events0 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0111 events1 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0082 events2 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

EG0150 events0 affected5 at risk

EG0040 events0 affected19 at risk

EG0050 events0 affected10 at risk

EG0060 events0 affected9 at risk

EG0070 events0 affected4 at risk

EG0081 events1 affected12 at risk

EG0090 events0 affected4 at risk

EG0100 events0 affected3 at risk

EG0110 events0 affected10 at risk

EG0120 events0 affected1 at risk

EG0130 events0 affected1 at risk

EG0140 events0 affected4 at risk

ID	Term
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries