Study to Investigate the Safety and Clinical Activity of... | NCT03614728

Label	Type	Intervention Names
Part 1: Participants receiving GSK3326595	Experimental	Drug: GSK3326595
Part 2 Dose escalation : Participants receiving GSK3326595+5-Azacitidine	Experimental	Drug: GSK3326595 Drug: 5-Azacitidine
Part 2 Dose expansion: Participants receiving GSK3326595+5-Azacitidine	Experimental	Drug: GSK3326595 Drug: 5-Azacitidine

Name	Type	Description	Arm Group Labels	Other Names
GSK3326595	Drug	GSK3326595 will be administered.	Part 1: Participants receiving GSK3326595 Part 2 Dose escalation : Participants receiving GSK3326595+5-Azacitidine

Measure	Description	Time Frame
Part 1: Percentage of Participants With Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants achieving a complete remission (CR), complete marrow remission (mCR), partial remission (PR), stable disease (SD) lasting at least 8 weeks, or hematologic improvement (HI), per International Working Group (IWG) criteria, where CR=Bone marrow:<=5 percent(%) myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by >=50% over pre-treatment but still >5%; mCR=Bone marrow: <=5% myeloblasts and decrease by >=50% over pre-treatment; SD= Failure to achieve at least PR, but no evidence of progression >8 weeks; HI=Erythroid (E): hemoglobin increase of >1.5 grams per deciliter (g/dL), HI-Platelet: increase of >30,000/milliliter (mL) (starting with >20,000/mL) and increase from <20,000/mL to >20,000/mL by >100%; HI-Neutrophil: increase of >100% and >500/microliter. Percentage values are rounded off.	Up to 30.8 months
Part 2: Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. Treatment emergent adverse event (TEAE) is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with non-STEAEs and STEAEs were planned to be assessed.	Up to 3 years and 2 months
Part 2: Number of Participants With AEs by Severity	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AEs by severity were planned to be assessed.

Measure	Description	Time Frame
Part 1: Number of Participants With Common Non-STEAEs and STEAEs	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs which were not serious, were considered as non-STEAEs.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35294-3300	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
39290981	Derived	Watts J, Minden MD, Bachiashvili K, Brunner AM, Abedin S, Crossman T, Zajac M, Moroz V, Egger JL, Tarkar A, Kremer BE, Barbash O, Borthakur G. Phase I/II study of the clinical activity and safety of GSK3326595 in patients with myeloid neoplasms. Ther Adv Hematol. 2024 Sep 14;15:20406207241275376. doi: 10.1177/20406207241275376. eCollection 2024.

ID	Title	Description
FG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 milligram (mg), tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
FG001	Part 1: GSK3326595 300 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 15, 2021	Dec 21, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Part 1: Percentage of Participants With Clinical Benefit Rate (CBR)

CBR is defined as the percentage of participants achieving a complete remission (CR), complete marrow remission (mCR), partial remission (PR), stable disease (SD) lasting at least 8 weeks, or hematologic improvement (HI), per International Working Group (IWG) criteria, where CR=Bone marrow:<=5 percent(%) myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by >=50% over pre-treatment but still >5%; mCR=Bone marrow: <=5% myeloblasts and decrease by >=50% over pre-treatment; SD= Failure to achieve at least PR, but no evidence of progression >8 weeks; HI=Erythroid (E): hemoglobin increase of >1.5 grams per deciliter (g/dL), HI-Platelet: increase of >30,000/milliliter (mL) (starting with >20,000/mL) and increase from <20,000/mL to >20,000/mL by >100%; HI-Neutrophil: increase of >100% and >500/microliter. Percentage values are rounded off.

All Treated Population consisted of all participants who received at least one dose of GSK3326595 as monotherapy or at least one dose of both combination drugs as combination treatment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 30.8 months

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants	OG00013 OG00117

Title

Denominators

Categories

Title	Measurements
	OG00015(1.9 to 45.4) OG00118(3.8 to 43.4)

Primary

Part 2: Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. Treatment emergent adverse event (TEAE) is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with non-STEAEs and STEAEs were planned to be assessed.

All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Up to 3 years and 2 months

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Primary

Part 2: Number of Participants With AEs by Severity

All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Up to 3 years and 2 months

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Primary

Part 2: Number of Participants With Dose Limiting Toxicities (DLTs)

An event is considered to be a DLT if the event occurs within the first 28 days of treatment meeting one of the following criteria of toxicity, Hematologic: Grade 4 or greater treatment-emergent neutropenia, anemia, or thrombocytopenia, lasting for >=14 days in the absence of Investigational Product, that cannot be attributed to underlying disease as described in National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4; Non-hematologic: Hepatic toxicity that meets Liver Stopping Criteria, Grade 3 nausea, vomiting or diarrhea that does not improve within 72 hours despite appropriate supportive treatments, Grade 4 or greater nausea, vomiting, or diarrhea of any duration, Any other Grade 3 or greater clinically significant non-hematologic toxicity; Other: Inability to receive all planned doses, dose interruption and Grade 2 or higher toxicity. Number of participants with DLTs were planned to be assessed.

DLT Evaluable Population is defined as participants who received at least 75 percent (%) of the planned doses of GSK3326595 and all seven planned doses of 5-Azacitidine (Part 2) within the 28-day DLT observation period or those who have had a DLT. Data was not collected as no participants were enrolled in Part 2.

Posted

Up to 28 days

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine

Primary

Part 2: Number of Participants With AEs Leading to Dose Interruptions, Dose Reductions and Treatment Discontinuation Due to AEs

Number of participants with AEs leading to dose interruptions, dose reductions and treatment discontinuation due to AEs were planned to be assessed.

All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Up to 3 years and 2 months

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 1: Number of Participants With Common Non-STEAEs and STEAEs

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs which were not serious, were considered as non-STEAEs.

All Treated Population

Posted

Count of Participants

Participants

Up to 30.8 months

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Secondary

Part 1: Number of Participants With AEs by Severity

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of each AE was reported during the study and was assigned a grade according to the NCI-CTCAE. AEs severity were graded as: Grade 1=mild; Grade 2=moderate; Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening consequences and Grade 5=death related to AE.

All Treated Population

Posted

Count of Participants

Participants

Up to 30.8 months

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Number of Participants With DLTs

An event is considered to be a DLT if the event occurs within the first 28 days of treatment meeting one of the following criteria of toxicity, Hematologic: Grade 4 or greater treatment-emergent neutropenia, anemia, or thrombocytopenia, lasting for >=14 days in the absence of Investigational Product, that cannot be attributed to underlying disease as described in NCI-CTCAE version 4; Non-hematologic: Hepatic toxicity that meets Liver Stopping Criteria, Grade 3 nausea, vomiting or diarrhea that does not improve within 72 hours despite appropriate supportive treatments, Grade 4 or greater nausea, vomiting, or diarrhea of any duration, Any other Grade 3 or greater clinically significant non-hematologic toxicity; Other: Inability to receive all planned doses, dose interruption and Grade 2 or higher toxicity.

DLT Evaluable Population. Only those participants with data available at the indicated time points were analyzed.

Posted

Count of Participants

Participants

Up to 28 days

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Secondary

Part 1: Overall Response Rate

Overall response rate is defined as the percentage of participants achieving a CR, mCR, or PR, per IWG criteria, where CR=Bone marrow: <=5% myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by >=50% over pre-treatment but still >5%; mCR= Bone marrow: ≤ 5% myeloblasts and decrease by >=50% over pre-treatment. Percentage values are rounded off.

All Treated Population.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 30.8 months

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Progression Free Survival

Progression free survival is defined as time from first dose to disease progression, as defined by IWG criteria, or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

All Treated Population.

Posted

Median

Inter-Quartile Range

Months

Up to 30.8 months

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants	OG000

Secondary

Part 1: Overall Survival

Overall survival is defined as time from first dose to death due to any cause.

All Treated Population.

Posted

Median

Inter-Quartile Range

Months

Up to 30.8 months

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants	OG000

Secondary

Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 Following Administration of Single Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

Pharmacokinetic (PK) Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

Day 1:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Cmax of GSK3326595 Following Administration of Repeat Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the indicated time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

Day 15:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Time of Maximum Concentration Observed (Tmax) of GSK3326595 Following Administration of Single Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population

Posted

Median

Full Range

Hours

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Tmax of GSK3326595 Following Administration of Repeat Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the indicated time points were analyzed.

Posted

Median

Full Range

Hours

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Apparent Terminal Phase Half-life (t1/2) of GSK3326595 Following Administration of Single Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the indicated time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: t1/2 of GSK3326595 Following Administration of Repeat Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within Participant Across All Treatments (AUC[0-t]) of GSK3326595 Following Administration of Single Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*nanogram per milliliter

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: AUC(0-t) of GSK3326595 Following Administration of Repeat Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*nanogram per milliliter

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: AUC From 0 Hours to the Time of Next Dosing (AUC[0-tau]) of GSK3326595

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*nanogram per milliliter

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 Following Administration of Single Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*nanogram per milliliter

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts

Secondary

Part 1: AUC(0-inf) of GSK3326595 Following Administration of Repeat Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*nanogram per milliliter

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Oral Clearance (CL/F) of GSK3326595 Following Administration of Single Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per hour

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: CL/F of GSK3326595 Following Administration of Repeat Dose

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per hour

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts
Participants

Secondary

Part 1: Time Invariance Following Administration of GSK3326595

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595. Time invariance was calculated as the ratio of AUC(0-24) on Day 15 divided by AUC(0-infinity) on Day 1 for GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

Days1and15:Pre-dose(within 1hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hour(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour),24hours(+/-2hour)post-dose

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts

Secondary

Part 1: Accumulation Ratio Following Administration of GSK3326595

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595. Accumulation ratio was calculated as the ratio of AUC(0-24) on Day 15 divided by AUC(0-24) on Day 1 for GSK3326595.

PK Population. Only those participants with data available at the specified time points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

ID	Title	Description
OG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
OG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Units	Counts

Secondary

Part 2: Complete Remission (CR) Rate

Complete remission rate is defined as percentage of participants achieving a CR per IWG criteria.

All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Up to 3 years and 2 months

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: Cmax of GSK3326595 Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: Cmax of GSK3326595 Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Day 8:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: Cmax of 5-Azacitidine Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: Cmax of 5-Azacitidine Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: Tmax of GSK3326595 Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: Tmax of GSK3326595 Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: Tmax of 5-Azacitidine Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: Tmax of 5-Azacitidine Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: t1/2 of GSK3326595 Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: t1/2 of GSK3326595 Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: t1/2 of 5-Azacitidine Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: t1/2 of 5-Azacitidine Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: AUC(0-t) of GSK3326595 Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: AUC(0-t) of GSK3326595 Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: AUC(0-t) of 5-Azacitidine Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: AUC(0-t) of 5-Azacitidine Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: AUC(0-inf) of GSK3326595 Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: AUC(0-inf) of GSK3326595 Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: AUC(0-inf) of 5-Azacitidine Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: AUC(0-inf) of 5-Azacitidine Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: AUC(0-tau) Following Administration of GSK3326595

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: AUC(0-tau) Following Administration of 5-Azacitidine

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: CL/F of GSK3326595 Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: CL/F of GSK3326595 Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: CL/F of 5-Azacitidine Following Administration of Single Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: CL/F of 5-Azacitidine Following Administration of Repeat Dose

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: Time Invariance Following Administration of GSK3326595

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Days 1 and 8:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour)post-dose

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: Time Invariance Following Administration of 5-Azacitidine

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: Accumulation Ratio Following Administration of GSK3326595

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Day 1 and 8:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour), 24hours(+/-2hour) post-dose

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants

Secondary

Part 2: Accumulation Ratio Following Administration of 5-Azacitidine

Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of 5-Azacitidine.

PK Population. Data was not collected as no participants were enrolled in Part 2.

Posted

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Secondary

Part 2: Overall Response Rate

Overall response rate is defined as the percentage of participants achieving a CR, mCR, or PR, per IWG criteria.

All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Posted

Up to 3 years and 2 months

ID	Title	Description
OG000	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
OG001	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0006 affected13 at risk EG0017 affected17 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected13 at risk EG0015 affected17 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0012 affected17 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0012 affected17 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0012 affected17 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected17 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected17 at risk
Rectal lesion	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Ascites	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Melaena	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Oesophageal discomfort	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Platelet count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 affected13 at risk EG0018 affected17 at risk
Neutrophil count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0016 affected17 at risk
International normalised ratio increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 affected13 at risk EG0013 affected17 at risk
Blood creatinine increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0004 affected13 at risk EG0012 affected17 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0011 affected17 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Prothrombin time prolonged	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Troponin T increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
White blood cell count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Blood urea increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Lipase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
White blood cell count increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Dysgeusia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0017 affected17 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected13 at risk EG0012 affected17 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0013 affected17 at risk
Balance disorder	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hemiparesis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Memory impairment	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Presyncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Syncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Tremor	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0007 affected13 at risk EG0016 affected17 at risk
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected13 at risk EG0012 affected17 at risk
Chills	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0012 affected17 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected13 at risk EG0010 affected17 at risk
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Non-cardiac chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Gait disturbance	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Influenza like illness	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Localised oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Swelling	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 affected13 at risk EG0016 affected17 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected13 at risk EG0012 affected17 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected17 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected17 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected13 at risk EG0014 affected17 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0015 affected17 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0013 affected17 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0012 affected17 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0013 affected17 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected17 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected13 at risk EG0012 affected17 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0005 affected13 at risk EG0011 affected17 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0011 affected17 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected17 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0017 affected17 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected17 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0014 affected17 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected17 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected17 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Nodular rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0011 affected17 at risk
Cellulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected17 at risk
Oral candidiasis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Abscess limb	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Abscess oral	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Arthritis infective	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Chronic sinusitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Herpes zoster	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Otitis media acute	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Rhinitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Sinusitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Skin infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Tooth infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0003 affected13 at risk EG0013 affected17 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Dysuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0012 affected17 at risk
Haematuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected17 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Micturition frequency decreased	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0012 affected17 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected17 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Vasculitis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Vision blurred	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected17 at risk
Retinal haemorrhage	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected17 at risk
Anxiety	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Delirium	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected17 at risk
Hypersensitivity	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected17 at risk

ID	Term
D009369	Neoplasms
D015470	Leukemia, Myeloid, Acute
D009190	Myelodysplastic Syndromes
D015477	Leukemia, Myelomonocytic, Chronic

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001855	Bone Marrow Diseases
D054437	Myelodysplastic-Myeloproliferative Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Title	Description
BG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 milligram (mg), tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
BG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
BG002	Part 2-Dose Escalation: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
BG003	Part 2-Dose Expansion: GSK3326595+5-Azacitidine	Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: GSK3326595 400 mg	Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.	11	13	11	13	12	13
EG001	Part 1: GSK3326595 300 mg	Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.	14	17	12	17	17	17