A Dose Escalation Study to Investigate the Safety, Pharma... | NCT01943851 | Trialant
NCT01943851
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Oct 1, 2024Actual
Enrollment
111Actual
Phase
Phase 2
Conditions
Neoplasms
Interventions
GSK525762
Countries
United States
Australia
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01943851
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
116183
Secondary IDs
ID
Type
Description
Link
2013-000445-39
EudraCT Number
Brief Title
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
Official Title
A Phase I/II Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 14, 2014Actual
Primary Completion Date
Apr 30, 2020Actual
Completion Date
Apr 30, 2020Actual
First Submitted Date
Sep 12, 2013
First Submission Date that Met QC Criteria
Sep 12, 2013
First Posted Date
Sep 17, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 26, 2021
Results First Submitted that Met QC Criteria
Apr 26, 2021
Results First Posted Date
May 19, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 6, 2024
Last Update Posted Date
Oct 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label repeat dose, multicenter, 2-part study to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily (QD) orally. Part 1 of the study is a dose escalation phase to select the recommended Part 2 dose (RP2D) based on the safety, PK, and PD profiles observed after oral administration of GSK525762. Eligible subjects with select relapsed refractory hematological malignancies (acute myeloid leukemia [AML], non-Hodgkin's Lymphoma [NHL]and multiple myeloma [MM]), will be enrolled in the QD and/or BID dosing cohorts until a MTD is established. Subjects may continue treatment in the study until disease progression, unacceptable toxicity, or withdrawal of consent. . Upon determination of the MTD, twice daily (BID) dosing cohorts may be opened to collect additional safety data and evaluate the preliminary efficacy of GSK525762 administered BID. Part 2 will explore clinical activity at the MTD or RP2D; separate expansion cohorts will be planned for acute myeloid leukemia (AML), non-Hodgkin's Lymphoma (NHL, including an exploratory sub-cohort of subjects with myc and B-Cell Leukemia (BCL)2 and/or BCL6 rearrangements/overexpression [double- and triple-hit lymphoma]), and multiple myeloma (MM). This is the first study of this agent to be conducted in subjects with these relapsed and/or refractory hematological malignancies for which no standard therapies are anticipated to result in a durable remission.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
leukemia
Acute myeloid leukemia
BET inhibitor
lymphoma
Myelodysplastic syndromes
Oncology
multiple myeloma
GSK525762
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
111Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: GSK525762 QD Cohort
Experimental
Subject will be administered a 5 milligram (mg) starting dose of GSK525762, oral tablets, QD. Dose escalations will be performed in Part 1 and dose adjustments are allowed to address tolerability and safety issues. Thereafter, subjects will be enrolled in a standard 3+3 design. Separate dose escalation cohorts will be opened for subjects with AML, NHL, and MM for QD dosing. Dose escalation will continue until an MTD is determined or until a dose of 200 mg per day is reached.
Drug: GSK525762
Part 1: GSK525762 BID Cohort
Experimental
Subject will be administered a starting dose of GSK525762, oral tablets, 20 mg BID (12 hours apart, total daily dose of 40 mg). Dose escalations will be performed in Part 1 and dose adjustments are allowed to address tolerability and safety issues. Thereafter, subjects will be enrolled in a standard 3+3 design. Separate dose escalation cohorts will be opened for subjects with AML, NHL, and MM, for BID dosing. Dose escalation will continue until an MTD is determined or until a dose of 200 mg per day is reached.
Drug: GSK525762
Part 2: GSK525762 dose expansion cohort
Experimental
After the MTD has been determined in Part1, Part 2 dose expansion cohorts will be opened for AML, NHL and MM.
Drug: GSK525762
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK525762
Drug
GSK525762 1 mg, 10 mg and 30 mg will be supplied as white to off-white, amorphous free base and white to slightly colored crystalline besylate tablets, round, biconvex tablets with no markings. GSK525762 will be administered with 240 milliliter (mL) water.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
Up to 86.9 weeks
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
An event was considered DLT if it occurred within first 3weeks of treatment & met one of following criteria:unless it was clearly established that event is unrelated to treatment:Grade4 neutropenia persisting for >=7 days/febrile neutropenia not responding to treatment within 24hours, Grade4 thrombocytopenia lasting more than 7day & not responding to transfusions/Grade3 thrombocytopenia associated with bleeding (>10milliliter [mL]), Drug-related Grade 3/4 non-hematologic toxicity as described in National Cancer Institute-Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 4.0, Drug-related Grade2 non-hematological toxicity, Grade2 Troponin T elevation(central laboratory>Upper Limit of Normal[ULN]),measured on two separate occasions within 48 hours, Treatment delay of 14 days/greater due to unresolved drug-related toxicity,ALT>=3xULN+bilirubin>=2xULN(>35% direct)/Alanine aminotransferase(ALT) between 3-5xULN with bilirubin<2xULN but with hepatitis symptom/rash/ALT>=5xULN.
Up to 3 weeks
Part 1: Number of Participants With Dose Reductions
Number of participants with dose reductions due to any reason is presented.
Up to 86.9 weeks
Part 1: Number of Participants With Any Dose Interruptions or Delays
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Overall Response Rate (ORR)- Investigator Assessment
ORR is defined as the percentage of participants achieving stringent complete response (sCR), very good partial response (VGPR), partial response (PR) or minimal response (MR) for multiple myeloma (MM); CR or PR for Non-Hodgkin's Lymphoma (NHL); CR, CRp, CRi or PR for Acute Myeloid Leukemia (AML); CR, MR or PR for Myelodysplastic Syndrome (MDS) using the International Working Group (IWG) response criteria and IWG response criteria in myelodysplasia.
Other Outcomes
Measure
Description
Time Frame
Part 2: Time to Progression (TTP) for Participants With MM
Time to Progression was planned to be analyzed.
Up to 36.4 weeks
Part 1: Changes in Cardiac QT Duration Corrected for Heart Rate by Fridericia's Formula (QTcF) and Other Safety Parameters in Relation to GSK525762 PK Concentrations
Eligibility Module
Eligibility Criteria
Inclusion criteria
Written informed consent provided.
Males and females 18 years old or older.
In Part 1 and, Part 2, subjects must have AML, MM, or NHL. Subjects with AML, are eligible if they • have relapsed and/or refractory disease, OR are>=65 years of age and not candidates for or have refused standard chemotherapy. Subjects with multiple myeloma are eligible if they have progressed despite therapy with an alkylating agent, proteasome inhibitor, and immunomodulatory agent, either as individual regimens or in combination. Subjects with NHL are eligible if they have received at least two prior lines of systemic therapy, including at least one line of immunochemotherapy with an anti-CD20 antibody (if their tumor expresses CD20).
In Part 2, the NHL cohort will separately enrol subjects with double- and triple hit lymphoma, so that a minimum of 10 subjects with this subset of disease will be enrolled. To be eligible for this sub-cohort, tumor sample from the subject must demonstrate rearrangement and/or overexpression of MYC and either BCL2 and/or BCL6 genes. Evaluation of double- or triple-hit status may be performed via appropriate local testing, and the determination of double- or triple-hit diagnosis will be at the discretion of the investigator and GSK Medical Monitor.
Subjects with a prior history of stem cell transplant (autologous and/or allogeneic) are allowed if
At least 3 months has elapsed from the time of transplant and
the subject has recovered from transplant-associated toxicities prior to the first dose of GSK525762, and For subjects with a prior history of allogeneic transplant,
the subject has been off systemic immunosuppressive medications (including but not limited to: cyclosporine, tacrolimus, mycophenolate mofetil, or corticosteroids) for at least 1 month prior to the first dose of GSK525762. Topical steroids are permitted
there are no signs or symptoms of graft versus host disease, other than Grade 1 skin involvement.
Eastern Cooperative Oncology Group (ECOG) performance status of <=1.
Subject must be stable enough to be expected to complete dosing through the DLT observation period as assessed by the investigator.
Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli-International units per milliliter and estradiol < 40 picograms per milliliter (< 140 picomole per liter) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods defined in protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 7 months after the last dose of study medication; Negative serum pregnancy test <= 7 days prior to first study drug dose; Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK525762 or at least 28 days (whichever is longer) following the last dose of study treatment.
Male subjects must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant must continue to use condoms for 7 days after stopping study medications.
Adequate organ system function.
Ability to comply with dietary and tobacco/alcohol abstinence requirements.
Exclusion Criteria
Haematological malignancy associated with human immunodeficiency virus (HIV) infection or solid organ transplant or history of known Hepatitis B Antigen or positive Hepatitis C antibody (confirmed by Recombinant ImmunoBlot Assay [RIBA], if available or alternately confirmed by Hepatitis C Virus [HCV] Ribonucleic acid [RNA]).
History or concurrent malignancy of solid tumours, except for below. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled even if less than 5 years have elapsed since treatment. Consult the GSK Medical Monitor if unsure whether second malignancies meet requirements specified above.
Currently receiving cancer therapy (chemotherapy, radiation therapy, immuno- therapy, biologic therapy, hormonal therapy, surgery, and/or tumour embolization).The following are allowed: Hydroxyurea for proliferative disease, Corticosteroids, Use of hematopoetic growth factors is permitted at the discretion of the investigator according to published guidelines (e.g., National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), etc.). The following are NOT allowed: Investigational anti cancer drug within 2 weeks prior to the first dose of GSK525762; Major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK525762 Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks.
Nitrosourea or mitomycin C within the last 6 weeks
Evidence of severe of uncontrolled infection.
Use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices, as appropriate.
Current use of a prohibited medication or requires any of these medications during treatment with the investigational drugs. This includes excluding current medications known or suspected to be associated QT prolongation. In addition, any subject who is expected to require a QT prolonging medication while on trial should not be enrolled.
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator.
Symptomatic or untreated Central nervous system (CNS) disease, Subjects with a history of CNS disease (leukemia, lymphoma or myeloma) are permitted to enrol if they have previously received appropriate therapy and CNS remission has been documented. Subject with primary CNS lymphoma (defined as isolated CNS lymphoma without systemic involvement) are excluded from study.
Cardiac abnormalities as evidenced by any of the following: History or current clinically significant uncontrolled arrhythmias or hypertension; Clinically significant conduction abnormalities or arrhythmias, subjects with Bundle Branch Block; Presence of cardiac pacemaker; History or evidence of current >=Class II congestive heart failure as defined by New York Heart Association (NYHA); History of acute coronary syndromes (including unstable angina and myocardial infarction), coronary angioplasty, or stenting within the past 3 months.
Any of the following ECG findings or assessments including: Baseline QTcF interval >=450 milliseconds; Clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
GSK525762 is a benzodiazepine class molecule. Any serious known immediate or delayed hypersensitivity reaction(s) to GSK525762 or idiosyncrasy to drugs chemically related to the investigational drug.
Evidence of hemoptysis within the last 7 days.
History of major gastrointestinal bleeding within the last 3 months or any evidence of active gastrointestinal bleeding excludes the subject.
Presence of gastrointestinal disease that would significantly affect compound absorption.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Little Rock
Arkansas
72205
United States
GSK Investigational Site
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Background
Bell C; Fennell K; Chan YC; Rambow F; Yeung M; Vassiliadis D; Lara L; Yeh P; Martelotto L; Rogiers A; Kremer B; Barbash O; Mohammad H; Johanson T; Burr M; Dhar A; Karpinich N; Tian L; Tyler D; MacPherson L; Shi J; Pinnawala N; Fong CY; Papenfuss A; Grimmond S; Dawson SJ; Allan R; Kruger R; Vakoc C; Goode D; Naik S; Gilan O; Lam E; Marine JC; Prinjha R; and Dawson M.Enhancer remodeling overcomes therapeutic resistance driven by epigenetic evolution in cancer.Nature.2019;
Dawson MA, Borthakur G, Huntly BJP, Karadimitris A, Alegre A, Chaidos A, Vogl DT, Pollyea DA, Davies FE, Morgan GJ, Glass JL, Kamdar M, Mateos MV, Tovar N, Yeh P, Delgado RG, Basheer F, Marando L, Gallipoli P, Wyce A, Krishnatry AS, Barbash O, Bakirtzi E, Ferron-Brady G, Karpinich NO, McCabe MT, Foley SW, Horner T, Dhar A, Kremer BE, Dickinson M. A Phase I/II Open-Label Study of Molibresib for the Treatment of Relapsed/Refractory Hematologic Malignancies. Clin Cancer Res. 2023 Feb 16;29(4):711-722. doi: 10.1158/1078-0432.CCR-22-1284.
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 111 participants were enrolled (87 participants in Part 1 and 24 participants in Part 2) across the study centers in Australia, Spain, Great Britain, South Korea and United State of America (USA).
Recruitment Details
This was an open-label repeat dose, multicenter study to investigate the safety, pharmacokinetics (PK), pharmacodynamics and clinical activity of GSK525762 in participants with relapsed, refractory hematologic malignancies. The study was conducted in 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
FG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
Periods
Title
Milestones
Reasons Not Completed
Part 1 (Up to 86.9 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 15, 2018
Mar 16, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Part 1: GSK525762 BID Cohort
Part 1: GSK525762 QD Cohort
Part 2: GSK525762 dose expansion cohort
Number of participants with any dose interruptions/ delays is presented.
Up to 86.9 weeks
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, prothrombin international normalized ratio (Pro. INR), albumin, amylase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, triglycerides, alkaline phosphatase (ALP). Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Up to 86.9 weeks
Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Up to 86.9 weeks
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Urine samples were collected to assess glucose, ketones, occult blood, urine protein, and monoclonal protein (monoclonal pro). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.
Up to 86.9 weeks
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
Up to 86.9 weeks
Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
Up to 86.9 weeks
Part 1: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Up to 86.9 weeks
Part 2: Objective Response Rate (ORR) (MDS Cohort)
ORR for MDS cohort is defined as the percentage of participants achieving Complete Response (CR), Marrow CR, CRp (as per CR but platelet count <100 x 10^9 cells/Liter[L]), CRi (as per CR but platelet count <100 x 10^9cells/L or neutrophil count <1 x 10^9 cells/L), or Partial Response (PR) per response criteria. Complete response is defined as bone marrow <=5% myeloblasts with normal maturation of all cell lines, with hemoglobin concentration of >=11 grams per deciliter (g/dL), absolute neutrophil count >=1 x 10^9 cells/L, platelet count >=100x10^9 cells/L and 0% blasts in the peripheral blood. Marrow CR is defined as Bone marrow <=5% myeloblasts and decrease by >=50% over pre-treatment. Objective response rate was determined by the investigator according to international myeloma working group (IMWG) response criteria.
Up to 36.4 weeks
Part 2: Objective Response Rate Lasting at Least 4 Months (ORR4) (CTCL Cohorts)
ORR4 for CTCL cohorts is defined as the percentage of participants that have achieved a CR or PR lasting at least 4 months per global response criteria and the modified severity weighted assessment tool (mSWAT). ORR4 and 95% exact confidence interval is presented.
Up to 36.4 weeks
Up to 86.9 weeks
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0-24]) and AUC Extrapolated to Infinity (AUC[0-inf]) of GSK525762 Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: AUC(0-24) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. AUC(0-24) represents AUC(0-tau) for repeat dose.
Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Maximum Observed Concentration (Cmax) and Minimum Plasma Concentration (Cmin) of GSK525762 Following Single Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Cmax and Cmin of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Trough Concentration (Ctau) of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 2 Day 7: Pre-dose on Days 4, 6 and 7
Part 1: Time of Maximum Concentration (Tmax) of GSK525762 Following Single Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Tmax of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Terminal Half Life (T1/2) of GSK525762 Following Single Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: T1/2 of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Time Invariance (RS) of GSK525762
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. RS was calculated by taking ratio of AUC(0-24) on Week 2 Day 7 to AUC(0-inf) on Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis.
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Accumulation Ratio (RO) of GSK525762
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. Accumulation ratio was calculated by taking ratio of AUC(0-24) in Week 2 Day 7 to AUC (0-24) in Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis.
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 2: Apparent Clearance (CL/F) of GSK525762 After Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
Part 2: Apparent Clearance (CL/F) of GSK525762 After Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 3 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK525762 Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK525762 Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 3 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
Part 1: AUC(0-24) and AUC[0-inf] of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for PK analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: AUC(0-24) and AUC(0-tau) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762. AUC(0-tau) is AUC(0-24) for repeat dose.
Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Trough Concentration (Ctau) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 2 Day 7: Pre-dose on Days 4, 6 and 7
Part 1: Tmax of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Tmax of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: T1/2 of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: T1/2 of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Time Invariance (RS) of GSK3529246 (Active Metabolite)
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. RS was calculated by taking ratio of AUC(0-24) on Week 2 Day 7 to AUC(0-inf) on Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 1: Accumulation Ratio (RO) of GSK3529246 (Active Metabolite)
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Accumulation ratio was calculated by taking ratio of AUC(0-24) in Week 2 Day 7 to AUC (0-24) in Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
Part 2: Apparent Clearance (CL/F) of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. PK parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 1 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
Part 2: Apparent Clearance (CL/F) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 3 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 1 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Week 3 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
The effects of treatment on disease-related symptoms/quality of life was assessed using the Skindex-29 Questionnaire, which inquires about how often (Never, Rarely, Sometimes, Often, All the time) during the previous 4 weeks the participant experienced the effect described in each of 29 items divided into 3 domains: Emotional (10 items), Symptoms (7 items) and Functioning (12 items). Responses to each item are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time). Skindex-29 scores were reported as three individual domain scale scores; a scale score is the mean of a participant's responses to items in a given domain. Each domain score ranges from 0 (no effect) to 100 (effect experienced all the time), higher score implies higher impact of skin disease. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is defined is post-dose visit value minus Baseline.
Baseline (pre-dose Week1 Day1) and Week 3, Week 7, Week 10, Week 16 and Week 24
Part 2: Number of Participants With Non-serious AEs and SAEs and AELDs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
Up to 36.4 weeks
Part 2: Number of Participants With Dose Reductions
Number of participants with dose reductions due to any reason is presented.
Up to 36.4 weeks
Part 2: Number of Participants With Dose Interruptions/Delays
Number of participants with any dose interruptions or delays is presented.
Up to 36.4 weeks
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, Prothrombin international normalized ratio (Pro. INR), albumin, amylase, ALT, AST, bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, Triglycerides, ALP. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Up to 36.4 weeks
Part 2: Number of Participants With Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Up to 36.4 weeks
Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Urine samples were collected to assess glucose, ketones, occult blood, urine protein. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.
Up to 36.4 weeks
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
Up to 36.4 weeks
Part 2: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: DBP and SBP
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
Up to 36.4 weeks
Part 2: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Up to 36.4 weeks
Part 2: Progression Free Survival (PFS)
PFS defined as interval of time(in months) between date of first dose & earlier of date of disease progression & date of death due to any cause.Progression is participants(pt's)with MDS & with <5% blasts:>=50% increase in blasts to>5% blasts/pt's with 5-10% blasts:>=50% increase to >10% blasts, for pt's with 10-20% blasts:>=50% increase to >20% blasts,for pt's with 20%-30% blasts:>=50% increase to >30% blasts, for CTCL progression is >=25% increase in skin disease from Baseline/new tumors (T3[1 or more tumors(>=1cm diameter]) in pt's with T1(Limited patches,papules&/or plaques covering <10% of the skin surface;may further stratify into T1a [patch only] versus T1b [plaque+-patch]),T2(Patches,papules/plaques covering >=10% of skin surface;may further stratify into T2a[patch only]versus T2b [plaque+-patch]) orT4(Confluence of erythema covering >=80% body surface area) only skin disease/loss of response in those with CR/PR, increase of skin score of > sum of nadir +50% Baseline score.
Up to 36.4 weeks
Part 2: Duration of Response (DOR)
Duration of response is defined as the time from the first documented evidence response (CR or PR lasting 4 months for CTCL; and CR, marrow CR, CRp, Cri or PR for MDS) until the first documented disease progression or death due to any cause. Median and inter-quartile range (first quartile and third quartile) of duration of response are presented.
Up to 36.4 weeks
Part 2: Overall Survival (OS)
OS is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.
Up to 36.4 weeks
Changes in QTcF and other safety parameters in relation to GSK525762 PK concentrations was planned to be analyzed.
Up to 86.9 weeks
Part 1: Number of Participants With Dose /Exposure Markers Related Change in Molecular Markers in Tumor Tissue and/or Peripheral Blood Samples
Number of participants with dose /exposure markers related change in molecular markers (e.g. gene transcription and/or expression of proteins regulated by Bromodomain [BRD] proteins) in tumor tissue and/or peripheral blood samples were planned to be analyzed.
Up to 86.9 weeks
Part 2: Plasma Concentrations of GSK525762 in Relationship With Safety and Efficacy Parameters Derived From Pharmacokinetic/Pharmacodynamic (PK/PD) Model
Plasma concentrations of GSK525762 in relationship with safety and efficacy parameters derived from PK/PD model was planned to be analyzed.
Up to 36.4 weeks
Part 2: Number of Participants With Dose /Exposure Markers Related Change in Molecular Markers in Tumor Tissue and/or Peripheral Blood Samples
Number of participants with dose /exposure markers related change in molecular markers (e.g. gene transcription and/or expression of proteins regulated by Bromodomain proteins) in tumor tissue and/or peripheral blood samples were planned to be analyzed.
Up to 36.4 weeks
Part 1: Overall Survival (OS)
Overall survival (defined as the interval of time in months between the date of first dose and the date of death due to any cause) was planned to be analyzed.
Up to 86.9 weeks
Aurora
Colorado
80045
United States
GSK Investigational Site
New York
New York
10065
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19104
United States
GSK Investigational Site
Houston
Texas
77030
United States
GSK Investigational Site
East Melbourne
Victoria
3002
Australia
GSK Investigational Site
Seoul
03722
South Korea
GSK Investigational Site
Seoul
06351
South Korea
GSK Investigational Site
Barcelona
08036
Spain
GSK Investigational Site
Madrid
28006
Spain
GSK Investigational Site
Madrid
28040
Spain
GSK Investigational Site
Málaga
29010
Spain
GSK Investigational Site
Salamanca
37007
Spain
GSK Investigational Site
Cambridge
CB2 0QQ
United Kingdom
GSK Investigational Site
London
W12 0NN
United Kingdom
FG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
FG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
FG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
FG005
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
FG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
FG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
FG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
FG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
FG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
FG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
FG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
FG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
FG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
FG015
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
FG016
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
FG017
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0035 subjects
FG0041 subjects
FG0054 subjects
FG0068 subjects
FG00718 subjects
FG0083 subjects
FG0098 subjects
FG0101 subjects
FG0117 subjects
FG0127 subjects
FG01316 subjects
FG0146 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG0040 subjects
FG0054 subjects
FG0067 subjects
FG00716 subjects
FG0082 subjects
FG0098 subjects
FG0101 subjects
FG0117 subjects
FG0127 subjects
FG01315 subjects
FG0146 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator discretion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2 (Up to 36.4 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0157 subjects
FG01616 subjects
FG0171 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NA indicates, Data not presented due to participant confidentiality and privacy concerns
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
BG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
BG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
BG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
BG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
BG005
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
BG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
BG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
BG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
BG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
BG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
BG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
BG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
BG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
BG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
BG015
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
BG016
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
BG017
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0021
BG0035
BG0041
BG0054
BG0068
BG00718
BG0083
BG0098
BG0101
BG0117
BG0127
BG01316
BG0146
BG0157
BG01616
BG0171
BG018111
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18-64 years
BG0001
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000NAData not presented due to patient confidentiality and privacy concerns
BG001NAData not presented due to patient confidentiality and privacy concerns
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Japanese Heritage(H)/eastAsian (H)/Southeast Asian (H)
BG000NAData not presented due to patient confidentiality and privacy concerns
BG001NAData not presented due to patient confidentiality and privacy concerns
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: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
All Treated Population consists of all participants that received at least one dose of study treatment.
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG0001
OG0011
OG0021
OG003
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
An event was considered DLT if it occurred within first 3weeks of treatment & met one of following criteria:unless it was clearly established that event is unrelated to treatment:Grade4 neutropenia persisting for >=7 days/febrile neutropenia not responding to treatment within 24hours, Grade4 thrombocytopenia lasting more than 7day & not responding to transfusions/Grade3 thrombocytopenia associated with bleeding (>10milliliter [mL]), Drug-related Grade 3/4 non-hematologic toxicity as described in National Cancer Institute-Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 4.0, Drug-related Grade2 non-hematological toxicity, Grade2 Troponin T elevation(central laboratory>Upper Limit of Normal[ULN]),measured on two separate occasions within 48 hours, Treatment delay of 14 days/greater due to unresolved drug-related toxicity,ALT>=3xULN+bilirubin>=2xULN(>35% direct)/Alanine aminotransferase(ALT) between 3-5xULN with bilirubin<2xULN but with hepatitis symptom/rash/ALT>=5xULN.
All Treated Population
Posted
Count of Participants
Participants
Up to 3 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
Primary
Part 1: Number of Participants With Dose Reductions
Number of participants with dose reductions due to any reason is presented.
All Treated Population
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Primary
Part 1: Number of Participants With Any Dose Interruptions or Delays
Number of participants with any dose interruptions/ delays is presented.
All Treated Population
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Primary
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, prothrombin international normalized ratio (Pro. INR), albumin, amylase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, triglycerides, alkaline phosphatase (ALP). Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
Primary
Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Primary
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Urine samples were collected to assess glucose, ketones, occult blood, urine protein, and monoclonal protein (monoclonal pro). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.
All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Primary
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
All Treated Population. Only those participants with data available at the specified data points were analyzed.
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
Primary
Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
All Treated Population.
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Primary
Part 1: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
All Treated Population.
Posted
Count of Participants
Participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Primary
Part 2: Objective Response Rate (ORR) (MDS Cohort)
ORR for MDS cohort is defined as the percentage of participants achieving Complete Response (CR), Marrow CR, CRp (as per CR but platelet count <100 x 10^9 cells/Liter[L]), CRi (as per CR but platelet count <100 x 10^9cells/L or neutrophil count <1 x 10^9 cells/L), or Partial Response (PR) per response criteria. Complete response is defined as bone marrow <=5% myeloblasts with normal maturation of all cell lines, with hemoglobin concentration of >=11 grams per deciliter (g/dL), absolute neutrophil count >=1 x 10^9 cells/L, platelet count >=100x10^9 cells/L and 0% blasts in the peripheral blood. Marrow CR is defined as Bone marrow <=5% myeloblasts and decrease by >=50% over pre-treatment. Objective response rate was determined by the investigator according to international myeloma working group (IMWG) response criteria.
All Treated Population
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
Units
Counts
Participants
Primary
Part 2: Objective Response Rate Lasting at Least 4 Months (ORR4) (CTCL Cohorts)
ORR4 for CTCL cohorts is defined as the percentage of participants that have achieved a CR or PR lasting at least 4 months per global response criteria and the modified severity weighted assessment tool (mSWAT). ORR4 and 95% exact confidence interval is presented.
All Treated Population.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG000
Secondary
Part 1: Overall Response Rate (ORR)- Investigator Assessment
ORR is defined as the percentage of participants achieving stringent complete response (sCR), very good partial response (VGPR), partial response (PR) or minimal response (MR) for multiple myeloma (MM); CR or PR for Non-Hodgkin's Lymphoma (NHL); CR, CRp, CRi or PR for Acute Myeloid Leukemia (AML); CR, MR or PR for Myelodysplastic Syndrome (MDS) using the International Working Group (IWG) response criteria and IWG response criteria in myelodysplasia.
All Treated Population.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Secondary
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0-24]) and AUC Extrapolated to Infinity (AUC[0-inf]) of GSK525762 Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population consisted of all participants in the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: AUC(0-24) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. AUC(0-24) represents AUC(0-tau) for repeat dose.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Secondary
Part 1: Maximum Observed Concentration (Cmax) and Minimum Plasma Concentration (Cmin) of GSK525762 Following Single Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter (ng/mL)
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Secondary
Part 1: Cmax and Cmin of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter (ng/mL)
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Secondary
Part 1: Trough Concentration (Ctau) of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter (ng/mL)
Week 2 Day 7: Pre-dose on Days 4, 6 and 7
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Secondary
Part 1: Time of Maximum Concentration (Tmax) of GSK525762 Following Single Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Median
Full Range
Hour
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Secondary
Part 1: Tmax of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Median
Full Range
Hour
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Secondary
Part 1: Terminal Half Life (T1/2) of GSK525762 Following Single Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Median
Full Range
Hour
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Secondary
Part 1: T1/2 of GSK525762 Following Repeat Dose Administration
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Median
Full Range
Hour
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Secondary
Part 1: Time Invariance (RS) of GSK525762
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. RS was calculated by taking ratio of AUC(0-24) on Week 2 Day 7 to AUC(0-inf) on Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Secondary
Part 1: Accumulation Ratio (RO) of GSK525762
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. Accumulation ratio was calculated by taking ratio of AUC(0-24) in Week 2 Day 7 to AUC (0-24) in Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Secondary
Part 2: Apparent Clearance (CL/F) of GSK525762 After Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS & N=0 for 80 mg QC CTCL arm for this outcome measure.
Posted
Mean
Standard Deviation
Liters per hour
Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Apparent Clearance (CL/F) of GSK525762 After Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Posted
Mean
Standard Deviation
Liters per hour
Week 3 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Secondary
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK525762 Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS & N=0 for 80 mg QC CTCL arm for this outcome measure.
Posted
Mean
Standard Deviation
Liters
Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK525762 Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Posted
Mean
Standard Deviation
Liters
Week 3 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Secondary
Part 1: AUC(0-24) and AUC[0-inf] of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for PK analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: AUC(0-24) and AUC(0-tau) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762. AUC(0-tau) is AUC(0-24) for repeat dose.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanograms per milliliter
Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter (ng/mL)
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter (ng/mL)
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: Trough Concentration (Ctau) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter (ng/mL)
Week 2 Day 7: Pre-dose on Days 4, 6 and 7
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: Tmax of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Median
Full Range
Hour
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: Tmax of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Median
Full Range
Hour
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: T1/2 of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Median
Full Range
Hour
Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Secondary
Part 1: T1/2 of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Median
Full Range
Hour
Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Secondary
Part 1: Time Invariance (RS) of GSK3529246 (Active Metabolite)
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. RS was calculated by taking ratio of AUC(0-24) on Week 2 Day 7 to AUC(0-inf) on Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Secondary
Part 1: Accumulation Ratio (RO) of GSK3529246 (Active Metabolite)
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Accumulation ratio was calculated by taking ratio of AUC(0-24) in Week 2 Day 7 to AUC (0-24) in Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Secondary
Part 2: Apparent Clearance (CL/F) of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. PK parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS & N=0 for 80 mg QC CTCL.
Posted
Mean
Standard Deviation
Liters per hour
Week 1 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Apparent Clearance (CL/F) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Posted
Mean
Standard Deviation
Liters per hour
Week 3 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK3529246 (Active Metabolite) Following Single Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS & N=0 for 80 mg QD CTCL.
Posted
Mean
Standard Deviation
Liters
Week 1 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Secondary
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Posted
Mean
Standard Deviation
Liters
Week 3 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dose
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
The effects of treatment on disease-related symptoms/quality of life was assessed using the Skindex-29 Questionnaire, which inquires about how often (Never, Rarely, Sometimes, Often, All the time) during the previous 4 weeks the participant experienced the effect described in each of 29 items divided into 3 domains: Emotional (10 items), Symptoms (7 items) and Functioning (12 items). Responses to each item are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time). Skindex-29 scores were reported as three individual domain scale scores; a scale score is the mean of a participant's responses to items in a given domain. Each domain score ranges from 0 (no effect) to 100 (effect experienced all the time), higher score implies higher impact of skin disease. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is defined is post-dose visit value minus Baseline.
All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Posted
Mean
Standard Deviation
Scores on a scale
Baseline (pre-dose Week1 Day1) and Week 3, Week 7, Week 10, Week 16 and Week 24
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Number of Participants With Non-serious AEs and SAEs and AELDs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
All Treated Population.
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Secondary
Part 2: Number of Participants With Dose Reductions
Number of participants with dose reductions due to any reason is presented.
All Treated Population.
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
Secondary
Part 2: Number of Participants With Dose Interruptions/Delays
Number of participants with any dose interruptions or delays is presented.
All Treated Population.
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
Secondary
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, Prothrombin international normalized ratio (Pro. INR), albumin, amylase, ALT, AST, bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, Triglycerides, ALP. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
Secondary
Part 2: Number of Participants With Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
All Treated Population.
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Secondary
Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Urine samples were collected to assess glucose, ketones, occult blood, urine protein. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.
All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
All Treated Population.
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
Secondary
Part 2: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: DBP and SBP
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
All Treated Population.
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Secondary
Part 2: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
All Treated Population.
Posted
Count of Participants
Participants
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Secondary
Part 2: Progression Free Survival (PFS)
PFS defined as interval of time(in months) between date of first dose & earlier of date of disease progression & date of death due to any cause.Progression is participants(pt's)with MDS & with <5% blasts:>=50% increase in blasts to>5% blasts/pt's with 5-10% blasts:>=50% increase to >10% blasts, for pt's with 10-20% blasts:>=50% increase to >20% blasts,for pt's with 20%-30% blasts:>=50% increase to >30% blasts, for CTCL progression is >=25% increase in skin disease from Baseline/new tumors (T3[1 or more tumors(>=1cm diameter]) in pt's with T1(Limited patches,papules&/or plaques covering <10% of the skin surface;may further stratify into T1a [patch only] versus T1b [plaque+-patch]),T2(Patches,papules/plaques covering >=10% of skin surface;may further stratify into T2a[patch only]versus T2b [plaque+-patch]) orT4(Confluence of erythema covering >=80% body surface area) only skin disease/loss of response in those with CR/PR, increase of skin score of > sum of nadir +50% Baseline score.
All Treated Population.
Posted
Median
Inter-Quartile Range
Months
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
Secondary
Part 2: Duration of Response (DOR)
Duration of response is defined as the time from the first documented evidence response (CR or PR lasting 4 months for CTCL; and CR, marrow CR, CRp, Cri or PR for MDS) until the first documented disease progression or death due to any cause. Median and inter-quartile range (first quartile and third quartile) of duration of response are presented.
All treated Population. Only those participants with data available at the specified data points were analyzed. Participants with incomplete response rates were excluded from the analysis hence N=0 for 60 mg QD and 80 mg QD CTCL arms.
Posted
Median
Inter-Quartile Range
Months
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Secondary
Part 2: Overall Survival (OS)
OS is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.
All Treated Population.
Posted
Median
Inter-Quartile Range
Months
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
Other Pre-specified
Part 2: Time to Progression (TTP) for Participants With MM
Time to Progression was planned to be analyzed.
All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Posted
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
Other Pre-specified
Part 1: Changes in Cardiac QT Duration Corrected for Heart Rate by Fridericia's Formula (QTcF) and Other Safety Parameters in Relation to GSK525762 PK Concentrations
Changes in QTcF and other safety parameters in relation to GSK525762 PK concentrations was planned to be analyzed.
All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Posted
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Other Pre-specified
Part 1: Number of Participants With Dose /Exposure Markers Related Change in Molecular Markers in Tumor Tissue and/or Peripheral Blood Samples
Number of participants with dose /exposure markers related change in molecular markers (e.g. gene transcription and/or expression of proteins regulated by Bromodomain [BRD] proteins) in tumor tissue and/or peripheral blood samples were planned to be analyzed.
All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Posted
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Other Pre-specified
Part 2: Plasma Concentrations of GSK525762 in Relationship With Safety and Efficacy Parameters Derived From Pharmacokinetic/Pharmacodynamic (PK/PD) Model
Plasma concentrations of GSK525762 in relationship with safety and efficacy parameters derived from PK/PD model was planned to be analyzed.
PK Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Posted
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
Other Pre-specified
Part 2: Number of Participants With Dose /Exposure Markers Related Change in Molecular Markers in Tumor Tissue and/or Peripheral Blood Samples
Number of participants with dose /exposure markers related change in molecular markers (e.g. gene transcription and/or expression of proteins regulated by Bromodomain proteins) in tumor tissue and/or peripheral blood samples were planned to be analyzed.
All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Posted
Up to 36.4 weeks
ID
Title
Description
OG000
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
OG001
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Other Pre-specified
Part 1: Overall Survival (OS)
Overall survival (defined as the interval of time in months between the date of first dose and the date of death due to any cause) was planned to be analyzed.
All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Posted
Up to 86.9 weeks
ID
Title
Description
OG000
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
OG001
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Time Frame
All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
Description
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
All-Cause Mortality Comment
Not provided
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
GSK525762 5 MG QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
1
1
1
1
1
1
EG001
GSK525762 10 MG QD
Participants were administered once daily oral dose of 10 mg GSK525762.
0
1
0
1
1
1
EG002
GSK525762 20 MG QD
Participants were administered once daily oral dose of 20 mg GSK525762.
1
1
0
1
1
1
EG003
GSK525762 30 MG QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
4
5
4
5
5
5
EG004
GSK525762 40 MG QD
Participants were administered once daily oral dose of 40 mg GSK525762.
0
1
0
1
1
1
EG005
GSK525762 40 MG QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
3
4
3
4
4
4
EG006
GSK525762 60 MG QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 40 mg GSK525762.
7
8
6
8
8
8
EG007
GSK525762 60 MG QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
12
18
12
18
18
18
EG008
GSK525762 60 MG QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
2
3
2
3
3
3
EG009
GSK525762 75 MG QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
8
8
8
8
8
8
EG010
GSK525762 80 MG QD
Participants were administered once daily oral dose of 80 mg GSK525762.
1
1
1
1
1
1
EG011
GSK525762 80 MG QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
7
7
6
7
7
7
EG012
GSK525762 80 MG QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
6
7
7
7
7
7
EG013
GSK525762 100 MG QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
15
16
14
16
16
16
EG014
GSK525762 120 MG QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
6
6
6
6
6
6
EG015
GSK525762 60 MG QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
1
7
5
7
7
7
EG016
GSK525762 75 MG QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
13
16
12
16
16
16
EG017
GSK525762 80 MG QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762.
0
1
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected8 at risk
EG0079 events8 affected18 at risk
EG0082 events1 affected3 at risk
EG0093 events3 affected8 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected7 at risk
EG0125 events5 affected7 at risk
EG0130 events0 affected16 at risk
EG0140 events0 affected6 at risk
EG0150 events0 affected7 at risk
EG0164 events4 affected16 at risk
EG0170 events0 affected1 at risk
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Amylase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Chalazion
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Chloroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Genital infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Herpes simplex reactivation
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperammonaemic encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Intracranial haematoma
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Ischaemia
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Mucormycosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Performance status decreased
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Staphylococcus test positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Starvation ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Troponin I increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
White blood cell count increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0032 events2 affected5 at risk
EG0042 events1 affected1 at risk
EG0052 events1 affected4 at risk
EG0066 events3 affected8 at risk
EG0078 events7 affected18 at risk
EG0080 events0 affected3 at risk
EG0094 events4 affected8 at risk
EG0102 events1 affected1 at risk
EG0116 events4 affected7 at risk
EG0123 events3 affected7 at risk
EG01315 events11 affected16 at risk
EG0143 events3 affected6 at risk
EG0152 events2 affected7 at risk
EG01614 events11 affected16 at risk
EG0170 events0 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected0 at risk
EG0010 events0 affected0 at risk
EG0020 events0 affected0 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected0 at risk
EG0010 events0 affected0 at risk
EG0020 events0 affected0 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0067
OG00718
OG0083
OG0098
OG0101
OG0117
OG0127
OG01316
OG0146
Title
Denominators
Categories
Hemoglobin, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0001
OG0010
OG0020
OG003
Lymphocytes, n=1,1,0,5,1,4,7,18,3,8,1,7,7,15,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0035
Neutrophils, n=1,1,0,5,1,4,7,18,3,8,1,7,7,15,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0035
Platelets, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
Leukocytes, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0041
OG0054
OG0065
OG00715
OG0083
OG0097
OG0101
OG0116
OG0125
OG01311
OG0142
Title
Denominators
Categories
Glucose, n=1,1,1,4,1,4,4,15, 3,5,0,3,5,8,1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0034
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG00715
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0100
ParticipantsOG0113
ParticipantsOG0125
ParticipantsOG0138
ParticipantsOG0141
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ketones, n=1,1,1,4,1,4,4,13,3,5,1,6,5,11,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0034
Occult blood, n=1,1,1,4,1,4,5,14,3,7,1,6,5,11,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0034
Protein, n=1,1,1,4,1,4,2,12,1,5,0,3,4,7,1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0034
Monoclonal pro, n=0,0,0,0,0,1,0,0,2,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0067
OG00718
OG0083
OG0098
OG0101
OG0117
OG0127
OG01316
OG0146
Title
Denominators
Categories
Pulse rate, To Low
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0062
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0131
OG0140
Pulse rate, To Normal or No change
Title
Measurements
OG0000
OG0011
OG0020
OG003
Pulse Rate, To High
Title
Measurements
OG0001
OG0010
OG0020
OG003
Temperature, To Low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Temperature, To Normal or No Change
Title
Measurements
OG0000
OG0011
OG0021
OG003
Temperature, To High,
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0067
OG00718
OG0083
OG0098
OG0101
OG0117
OG0127
OG01316
OG0146
Title
Denominators
Categories
DBP
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
OG0121
OG0130
OG0140
SBP
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0068
OG00718
OG0083
OG0098
OG0101
OG0117
OG0127
OG01316
OG0146
Title
Denominators
Categories
Abnormal-Clinically significant
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0051
OG0061
OG0071
OG0080
OG0093
OG0100
OG0110
OG0122
OG0134
OG0141
Abnormal-Not Clinically significant
Title
Measurements
OG0001
OG0011
OG0020
OG003
OG000
16
Title
Denominators
Categories
Title
Measurements
OG00025(7.3 to 52.4)
7
OG0011
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 41)
OG0010(0 to 97.5)
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0068
OG00718
OG0083
OG0098
OG0101
OG0117
OG0127
OG01316
OG0146
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 97.5)
OG0010(0 to 97.5)
OG0020(0 to 97.5)
OG0030(0 to 52.2)
OG0040(0 to 97.5)
OG0050(0 to 60.2)
OG00625(3.2 to 65.1)
OG0076(0.1 to 27.3)
OG0080(0 to 70.8)
OG0090(0 to 36.9)
OG0100(0 to 97.5)
OG01114(0.4 to 57.9)
OG01229(3.7 to 71.0)
OG01313(1.6 to 38.3)
OG01417(0.4 to 64.1)
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0068
OG00718
OG0083
OG0098
OG0101
OG0116
OG0127
OG01316
OG0146
Title
Denominators
Categories
AUC(0-24), n=1,1,1,5,1,4,8,18,3,8,1,6,7,16, 6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0116
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG000460.48± NAGeometric coefficient of variation could not be calculated for a single participant.
OG0011024.49± NAGeometric coefficient of variation could not be calculated for a single participant
OG0022881.41± NAGeometric coefficient of variation could not be calculated for a single participant
OG003
AUC(0-inf), n=1,1,1,5,1,4,7,17,3,8,1,5,7,16,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0035
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0041
OG0054
OG0063
OG00711
OG0082
OG0097
OG0101
OG0116
OG0124
OG01311
OG0142
Title
Denominators
Categories
AUC(0-24)
Title
Measurements
OG000476.71± NAGeometric coefficient of variation could not be calculated for a single participant
OG001656.93± NAGeometric coefficient of variation could not be calculated for a single participant
OG0021855.07± NAGeometric coefficient of variation could not be calculated for a single participant
OG0031908.18± 27.53
OG0042490.25± NAGeometric coefficient of variation could not be calculated for a single participant
OG0051702.37± 58.17
OG0066271.43± 38.76
OG0073576.49± 30.59
OG008931.02± 53.64
OG0095883.76± 48.48
OG0105188.25± NAGeometric coefficient of variation could not be calculated for a single participant
OG0116892.57± 71.96
OG0122994.24± 37.27
OG0139440.98± 84.11
OG0145296.46± 8.89
AUC(0-tau)
Title
Measurements
OG000476.71± NAGeometric coefficient of variation could not be calculated for a single participant
OG001656.93± NAGeometric coefficient of variation could not be calculated for a single participant
OG0021855.07± NAGeometric coefficient of variation could not be calculated for a single participant
OG003
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0068
OG00718
OG0083
OG0098
OG0101
OG0116
OG0127
OG01316
OG0146
Title
Denominators
Categories
Cmax
Title
Measurements
OG00090.56± NAGeometric coefficient of variation could not be calculated for a single participant
OG001116.69± NAGeometric coefficient of variation could not be calculated for a single participant
OG002559.14± NAGeometric coefficient of variation could not be calculated for a single participant
OG003442.77± 31.83
OG004513.03± NAGeometric coefficient of variation could not be calculated for a single participant
OG005660.79± 71.94
OG006853.03± 31.1
OG0071158.66± 28.58
OG008813.87± 27.91
OG0091728.80± 35.37
OG0101248.10± NAGeometric coefficient of variation could not be calculated for a single participant
OG0111444.42± 29.92
OG0121073.51± 38.46
OG0132335.99± 23.05
OG0141793.39± 42.16
Cmin
Title
Measurements
OG0001.11± NAGeometric coefficient of variation could not be calculated for a single participant
OG00127.86± NAGeometric coefficient of variation could not be calculated for a single participant
OG00220.62± NAGeometric coefficient of variation could not be calculated for a single participant
OG003
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0041
OG0054
OG0063
OG00711
OG0082
OG0097
OG0101
OG0116
OG0124
OG01311
OG0142
Title
Denominators
Categories
Cmax
Title
Measurements
OG000102.86± NAGeometric coefficient of variation could not be calculated for a single participant
OG001118.59± NAGeometric coefficient of variation could not be calculated for a single participant
OG002550.01± NAGeometric coefficient of variation could not be calculated for a single participant
OG003387.66± 52.41
OG004557.60± NAGeometric coefficient of variation could not be calculated for a single participant
OG005566.59± 57.75
OG0061070.32± 37.26
OG0071179.42± 28.10
OG008512.78± 48.37
OG0091384.46± 35.35
OG0101752.86± NAGeometric coefficient of variation could not be calculated for a single participant
OG0111314.21± 58.58
OG012725.29± 46.79
OG0131587.25± 50.83
OG014921.35± 52.16
Cmin
Title
Measurements
OG0001.47± NAGeometric coefficient of variation could not be calculated for a single participant
OG0015.03± NAGeometric coefficient of variation could not be calculated for a single participant
OG0023.92± NAGeometric coefficient of variation could not be calculated for a single participant
OG003
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0041
OG0054
OG0063
OG00711
OG0082
OG0097
OG0101
OG0116
OG0124
OG01311
OG0142
Title
Denominators
Categories
Title
Measurements
OG0000.91± NAGeometric coefficient of variation could not be calculated for a single participant
OG0013.90± NAGeometric coefficient of variation could not be calculated for a single participant
OG0023.76± NAGeometric coefficient of variation could not be calculated for a single participant
OG0034.88± 78.94
OG0048.12± NAGeometric coefficient of variation could not be calculated for a single participant
OG0052.26± 114.63
OG00632.85± 88.47
OG0075.99± 41.92
OG0080.03± 128.56
OG00913.21± 102.35
OG0102.08± NAGeometric coefficient of variation could not be calculated for a single participant
OG01115.77± 123.78
OG0122.25± 92.05
OG01342.18± 139.74
OG01414.34± 68.62
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0068
OG00718
OG0083
OG0098
OG0101
OG0116
OG0127
OG01316
OG0146
Title
Denominators
Categories
Title
Measurements
OG0000.62(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0012.00(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0021.00(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0031.00(0.5 to 1.0)
OG0041.00(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0050.78(0.4 to 2.0)
OG0061.56(0.3 to 2.1)
OG0071.00(0.3 to 4.1)
OG0081.00(0.5 to 2.2)
OG0090.86(0.5 to 2.1)
OG0101.28(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0111.03(0.5 to 2.0)
OG0121.00(0.3 to 1.2)
OG0130.92(0.3 to 4.0)
OG0141.58(0.2 to 4.1)
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0041
OG0054
OG0063
OG00711
OG0082
OG0097
OG0101
OG0116
OG0124
OG01311
OG0142
Title
Denominators
Categories
Title
Measurements
OG0000.67(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0010.00(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0020.83(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0031.26(0.5 to 2.0)
OG0040.50(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0050.78(0.5 to 1.2)
OG0060.58(0.5 to 2.0)
OG0070.50(0.3 to 2.0)
OG0080.63(0.3 to 1.0)
OG0090.60(0.3 to 4.0)
OG0100.50(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0110.98(0.5 to 2.0)
OG0121.06(0.6 to 2.0)
OG0132.00(0.5 to 4.0)
OG0142.33(0.5 to 4.2)
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0068
OG00717
OG0083
OG0098
OG0101
OG0115
OG0127
OG01316
OG0145
Title
Denominators
Categories
Title
Measurements
OG0004.01(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0015.75(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0026.27(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0034.55(1.4 to 6.4)
OG0045.10(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0054.07(3.5 to 4.6)
OG0066.48(5.2 to 10.3)
OG0073.96(2.9 to 9.3)
OG0085.55(1.4 to 8.1)
OG0094.57(3.3 to 6.3)
OG0104.15(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0114.75(4.1 to 7.4)
OG0124.06(3.0 to 5.8)
OG0135.66(1.9 to 9.7)
OG0146.53(4.7 to 7.5)
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0041
OG0054
OG0063
OG00711
OG0082
OG0096
OG0101
OG0116
OG0124
OG01311
OG0142
Title
Denominators
Categories
Title
Measurements
OG0003.68(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0015.64(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0024.70(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0034.15(2.9 to 6.4)
OG0044.39(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0054.39(3.2 to 5.8)
OG0066.48(3.4 to 7.8)
OG0073.51(3.0 to 5.3)
OG0081.96(1.7 to 2.3)
OG0093.97(3.1 to 5.3)
OG0102.54(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0114.98(2.4 to 5.9)
OG0123.22(2.2 to 3.7)
OG0135.51(3.2 to 8.6)
OG0144.09(3.8 to 4.4)
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0035
OG0041
OG0054
OG0063
OG00710
OG0082
OG0097
OG0101
OG0117
OG0124
OG01311
OG0141
Title
Denominators
Categories
Title
Measurements
OG0001.02± NAGeometric coefficient of variation could not be calculated for a single participant
OG0010.60± NAGeometric coefficient of variation could not be calculated for a single participant
OG0020.61± NAGeometric coefficient of variation could not be calculated for a single participant
OG0030.71± 35.82
OG0040.72± NAGeometric coefficient of variation could not be calculated for a single participant
OG0050.67± 18.60
OG0060.98± 11.73
OG0070.65± 31.37
OG0080.32± 53.56
OG0090.78± 46.56
OG0100.86± NAGeometric coefficient of variation could not be calculated for a single participant
OG0110.91± 36.22
OG0120.74± 19.36
OG0130.76± 84.74
OG0140.54± NAGeometric coefficient of variation could not be calculated for a single participant
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0041
OG0054
OG0063
OG00711
OG0082
OG0097
OG0101
OG0115
OG0124
OG01311
OG0142
Title
Denominators
Categories
Title
Measurements
OG0001.04± NAGeometric coefficient of variation could not be calculated for a single participant
OG0010.64± NAGeometric coefficient of variation could not be calculated for a single participant
OG0020.64± NAGeometric coefficient of variation could not be calculated for a single participant
OG0030.74± 36.67
OG0040.75± NAGeometric coefficient of variation could not be calculated for a single participant
OG0050.68± 17.66
OG0061.06± 13.47
OG0070.67± 29.24
OG0080.33± 47.64
OG0090.81± 45.70
OG0100.87± NAGeometric coefficient of variation could not be calculated for a single participant
OG0111.01± 33.69
OG0120.75± 20.27
OG0130.81± 82.45
OG0140.71± 24.96
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00117
OG0020
Title
Denominators
Categories
Title
Measurements
OG00011.80± 3.39
OG0017.98± 3.32
Units
Counts
Participants
OG0007
OG0018
OG0020
Title
Denominators
Categories
Title
Measurements
OG00011.80± 3.39
OG0019.33± 4.01
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00117
OG0020
Title
Denominators
Categories
Title
Measurements
OG00051.5± 19.50
OG00147.9± 8.01
Units
Counts
Participants
OG0007
OG0018
OG0020
Title
Denominators
Categories
Title
Measurements
OG00051.5± 19.50
OG00145.8± 9.92
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0035
OG0040
OG0051
OG0060
OG00715
OG0082
OG0098
OG0100
OG0110
OG0126
OG01315
OG0140
Title
Denominators
Categories
AUC(0-24), n=0,0,0,5,0,1,0,15, 2,8,0,0,6,15,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG00715
ParticipantsOG0082
ParticipantsOG0098
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0126
ParticipantsOG01315
ParticipantsOG0140
Title
Measurements
OG0031368.11± 31.39
OG0051891.48± NAGeometric coefficient of variation could not be calculated for a single participant
OG0073048.33± 22.85
OG008
AUC(0-inf), n=0,0,0,5,0,1,0,10, 2,7,0,0,6,7,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0040
OG0051
OG0060
OG0079
OG0082
OG0097
OG0100
OG0110
OG0124
OG01310
OG0140
Title
Denominators
Categories
AUC(0-24)
Title
Measurements
OG0031517.96± 33.88
OG0051922.77± NAGeometric coefficient of variation could not be calculated for a single participant
OG0074870.28± 46.15
OG0083838.35± 37.18
OG0095312.66± 45.30
OG0123379.85± 44.24
OG0138534.92± 43.93
AUC(0-tau)
Title
Measurements
OG0031517.96± 33.88
OG0051922.77± NAGeometric coefficient of variation could not be calculated for a single participant
OG0074870.28± 46.15
OG008
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0035
OG0040
OG0051
OG0060
OG00715
OG0083
OG0098
OG0100
OG0110
OG0127
OG01316
OG0140
Title
Denominators
Categories
Cmax, n=0,0,0,5,0,1, 0,15,3,8,0,0,7,16,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG00715
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0140
Title
Measurements
OG003109.45± 45.38
OG005246.12± NAGeometric coefficient of variation could not be calculated for a single participant
OG007239.98± 26.75
OG008
Cmin, n=0,0,0,2,0,1, 0,14,3,7,0,0,6,13,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0040
OG0051
OG0060
OG0079
OG0082
OG0097
OG0100
OG0110
OG0124
OG01311
OG0140
Title
Denominators
Categories
Cmax
Title
Measurements
OG003121.83± 26.75
OG005282.72± NAGeometric coefficient of variation could not be calculated for a single participant
OG007453.89± 34.07
OG008500.61± 22.83
OG009445.47± 52.02
OG012370.67± 35.23
OG013557.92± 31.81
Cmin
Title
Measurements
OG00327.14± 28.38
OG00515.18± NAGeometric coefficient of variation could not be calculated for a single participant
OG00766.49± 81.56
OG008
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0040
OG0051
OG0060
OG0079
OG0082
OG0097
OG0100
OG0110
OG0124
OG01310
OG0140
Title
Denominators
Categories
Title
Measurements
OG00322.48± 36.13
OG00513.26± NAGeometric coefficient of variation could not be calculated for a single participant
OG00764.57± 77.46
OG00840.42± 43.96
OG00976.23± 62.65
OG01228.29± 94.01
OG013178.76± 69.25
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0035
OG0040
OG0051
OG0060
OG00715
OG0083
OG0098
OG0100
OG0110
OG0127
OG01316
OG0140
Title
Denominators
Categories
Title
Measurements
OG0031.92(0.9 to 4.1)
OG0050.58(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0072.10(0.5 to 8.0)
OG0084.00(2.0 to 4.2)
OG0093.15(1.2 to 4.1)
OG0122.08(0.3 to 4.2)
OG0134.03(2.0 to 17.5)
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0040
OG0051
OG0060
OG0079
OG0082
OG0097
OG0100
OG0110
OG0124
OG01311
OG0140
Title
Denominators
Categories
Title
Measurements
OG0032.48(1.0 to 4.0)
OG0050.60(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
OG0071.03(0.5 to 4.0)
OG0081.00(1.0 to 1.0)
OG0092.05(0.6 to 4.0)
OG0122.02(1.2 to 4.1)
OG0134.00(0.9 to 10.1)
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0035
OG0040
OG0051
OG0060
OG00711
OG0082
OG0096
OG0100
OG0110
OG0126
OG0137
OG0140
Title
Denominators
Categories
Title
Measurements
OG0039.90(5.2 to 13.4)
OG0055.83(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
OG0078.66(6.7 to 14.1)
OG00812.72(11.5 to 13.9)
OG0098.31(5.4 to 15.7)
OG0127.16(6.3 to 9.1)
OG0139.23(5.1 to 15.7)
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0040
OG0051
OG0060
OG0079
OG0082
OG0096
OG0100
OG0110
OG0124
OG0138
OG0140
Title
Denominators
Categories
Title
Measurements
OG0038.24(7.7 to 10.0)
OG0056.19(NA to NA)Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant
OG0077.97(5.7 to 12.4)
OG0087.39(7.3 to 7.5)
OG0098.00(5.8 to 10.5)
OG0126.72(4.0 to 8.7)
OG01311.77(6.9 to 23.8)
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0040
OG0051
OG0060
OG0078
OG0081
OG0096
OG0100
OG0110
OG0124
OG0136
OG0140
Title
Denominators
Categories
Title
Measurements
OG0030.92± 25.58
OG0050.96± NAGeometric coefficient of variation could not be calculated for a single participant
OG0071.18± 32.33
OG0080.63± NAGeometric coefficient of variation could not be calculated for a single participant
OG0091.20± 13.74
OG0121.06± 9.48
OG0131.87± 57.15
Participants were administered once daily oral dose of 20 mg GSK525762.
OG003
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0034
OG0040
OG0051
OG0060
OG0079
OG0081
OG0097
OG0100
OG0110
OG0124
OG0139
OG0140
Title
Denominators
Categories
Title
Measurements
OG0031.18± 25.71
OG0051.02± NAGeometric coefficient of variation could not be calculated for a single participant
OG0071.61± 31.61
OG0080.90± NAGeometric coefficient of variation could not be calculated for a single participant
OG0091.56± 26.04
OG0121.20± 11.50
OG0133.22± 59.05
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00117
OG0020
Title
Denominators
Categories
Title
Measurements
OG00016.5± 7.71
OG00115.8± 6.97
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG0018
OG0020
Title
Denominators
Categories
Title
Measurements
OG00015.9± 7.26
OG00114.6± 8.07
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00117
OG0020
Title
Denominators
Categories
Title
Measurements
OG00080.0± 37.1
OG00171.5± 28.4
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG0018
OG0020
Title
Denominators
Categories
Title
Measurements
OG00080.0± 37.1
OG00163.4± 30.6
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0006
OG0011
Title
Denominators
Categories
Emotional score, Week 3, n=6,1
ParticipantsOG0006
ParticipantsOG0011
Title
Measurements
OG000-5.83± 15.221
OG0019.17± NAStandard deviation could not be calculated for a single participant
Emotional score, Week 7, n=5,0
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG000-19.50± 22.735
Emotional score, Week 10, n=3,0
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000-44.17± 26.497
Emotional score, Week 16, n=3,0
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000-10.00± 10.897
Emotional score, Week 24, n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG000-18.75± 1.768
Functioning score, Week 3, n=6,1
ParticipantsOG0006
ParticipantsOG0011
Title
Measurements
OG000-1.42± 7.742
OG001
Functioning score, Week 7, n=5,0
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG000-13.37± 23.000
Functioning score, Week 10, n=3,0
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000-35.67± 27.820
Functioning score, Week 16, n=3,0
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000-13.45± 9.788
Functioning score, Week 24, n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG000-18.84± 11.919
Symptoms score, Week 3, n=6,1
ParticipantsOG0006
ParticipantsOG0011
Title
Measurements
OG0006.55± 24.055
OG001
Symptoms score, Week 7, n=5,0
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG000-2.14± 18.489
Symptoms score, Week 10, n=3,0
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000-29.76± 20.927
Symptoms score, Week 16, n=3,0
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG000-8.33± 19.670
Symptoms score, Week 24, n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG000-14.29± 10.102
Units
Counts
Participants
OG0007
OG00116
OG0021
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG0007
OG00116
OG0021
SAEs
Title
Measurements
OG0005
OG00112
OG0021
AELD
Title
Measurements
OG0000
OG0019
OG0020
OG000
7
OG00116
OG0021
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG0020
OG000
7
OG00116
OG0021
Title
Denominators
Categories
Title
Measurements
OG0007
OG00113
OG0021
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00116
OG0021
Title
Denominators
Categories
Glucose, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG0006
OG00114
OG0021
Pro.INR, n=4,13,0
ParticipantsOG0004
ParticipantsOG00113
ParticipantsOG0020
Title
Measurements
OG000
Albumin, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
ALT, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Amylase, n=7,15,1
ParticipantsOG0007
ParticipantsOG00115
ParticipantsOG0021
Title
Measurements
OG000
AST, n=7,15,1
ParticipantsOG0007
ParticipantsOG00115
ParticipantsOG0021
Title
Measurements
OG000
Bilirubin, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Calcium, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Calcium Ionized, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Cholesterol, n=7,15,1
ParticipantsOG0007
ParticipantsOG00115
ParticipantsOG0021
Title
Measurements
OG000
Creatine Kinase, n=5,11,1
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG0021
Title
Measurements
OG000
Creatinine, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Lipase, n=7,13,1
ParticipantsOG0007
ParticipantsOG00113
ParticipantsOG0021
Title
Measurements
OG000
Potassium, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Magnesium, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Sodium, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Triglycerides, n=7,15,1
ParticipantsOG0007
ParticipantsOG00115
ParticipantsOG0021
Title
Measurements
OG000
ALP, n=7,16,1
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG0021
Title
Measurements
OG000
Units
Counts
Participants
OG0007
OG00116
OG0021
Title
Denominators
Categories
Hemoglobin
Title
Measurements
OG0004
OG0018
OG0021
Lymphocytes
Title
Measurements
OG0004
OG0018
OG0021
Neutrophils
Title
Measurements
OG0002
OG0017
OG0020
Platelets
Title
Measurements
OG0005
OG0019
OG0021
Leukocytes
Title
Measurements
OG0001
OG0016
OG0020
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00112
OG0021
Title
Denominators
Categories
Glucose, n=5,12,1
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0021
Title
Measurements
OG0004
OG0013
OG0020
Ketones, n=7,12,1
ParticipantsOG0007
ParticipantsOG00112
ParticipantsOG0021
Title
Measurements
OG000
Occult blood, n=7,8,1
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0021
Title
Measurements
OG000
Protein, n=6,11,1
ParticipantsOG0006
ParticipantsOG00111
ParticipantsOG0021
Title
Measurements
OG000
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00116
OG0021
Title
Denominators
Categories
Pulse rate, To Low
Title
Measurements
OG0002
OG0010
OG0020
Pulse rate, To Normal or No change
Title
Measurements
OG0003
OG0019
OG0020
Pulse Rate, To High
Title
Measurements
OG0003
OG0017
OG0021
Temperature, To Low
Title
Measurements
OG0001
OG0010
OG0020
Temperature, To Normal or No Change
Title
Measurements
OG0005
OG00113
OG0021
Temperature, To High
Title
Measurements
OG0001
OG0013
OG0020
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00116
OG0021
Title
Denominators
Categories
DBP
Title
Measurements
OG0000
OG0010
OG0020
SBP
Title
Measurements
OG0003
OG0011
OG0021
Units
Counts
Participants
OG0007
OG00116
OG0021
Title
Denominators
Categories
Abnormal-Clinically significant
Title
Measurements
OG0000
OG0011
OG0020
Abnormal-Not Clinically significant
Title
Measurements
OG0006
OG00111
OG0021
OG002
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
Units
Counts
Participants
OG0007
OG00116
OG0021
Title
Denominators
Categories
Title
Measurements
OG0008.15(3.48 to NA)Third quartile could not be calculated
OG0012.00(1.45 to 3.48)
OG002NA(NA to NA)No event occurred for single participant hence Median and Inter-quartile range could not be calculated
Units
Counts
Participants
OG0000
OG0014
OG0020
Title
Denominators
Categories
Title
Measurements
OG0013.29(3.29 to 3.29)
OG0007
OG00116
OG0021
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and inter-quartile range was not reached.
OG0015.85(1.46 to 16.10)
OG002NA(NA to NA)No event occurred for single participant hence Median and Inter-quartile range could not be calculated.
OG000
0
OG0010
OG0020
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG004
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0000
OG0010
OG0020
Units
Counts
Participants
OG0000
OG0010
OG0020
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
OG005
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
OG006
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
OG007
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
OG008
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
OG009
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
OG010
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
OG011
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
OG012
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
OG013
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
OG014
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected8 at risk
EG0101 events1 affected1 at risk
EG0115 events3 affected7 at risk
EG0122 events2 affected7 at risk
EG01311 events5 affected16 at risk
EG0143 events1 affected6 at risk
EG0150 events0 affected7 at risk
EG0160 events0 affected16 at risk
EG0170 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected8 at risk
EG0100 events0 affected1 at risk
EG0113 events3 affected7 at risk
EG0120 events0 affected7 at risk
EG0133 events2 affected16 at risk
EG0143 events3 affected6 at risk
EG0150 events0 affected7 at risk
EG0160 events0 affected16 at risk
EG0170 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected7 at risk
EG0134 events4 affected16 at risk
EG0142 events2 affected6 at risk
EG0150 events0 affected7 at risk
EG0162 events1 affected16 at risk
EG0170 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected7 at risk
EG0132 events2 affected16 at risk
EG0140 events0 affected6 at risk
EG0150 events0 affected7 at risk
EG0161 events1 affected16 at risk
EG0170 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0072 events2 affected18 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected7 at risk
EG0133 events1 affected16 at risk
EG0140 events0 affected6 at risk
EG0150 events0 affected7 at risk
EG0161 events1 affected16 at risk
EG0170 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected18 at risk
EG0082 events1 affected3 at risk
EG0091 events1 affected8 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected7 at risk
EG0120 events0 affected7 at risk
EG0132 events2 affected16 at risk
EG0140 events0 affected6 at risk
EG0150 events0 affected7 at risk
EG0160 events0 affected16 at risk
EG0170 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected7 at risk
EG0132 events2 affected16 at risk
EG0140 events0 affected6 at risk
EG0150 events0 affected7 at risk
EG0160 events0 affected16 at risk
EG0170 events0 affected1 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected18 at risk
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0 events
0 affected
5 at risk
EG0040 events0 affected1 at risk
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1 events
1 affected
5 at risk
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2 events
2 affected
5 at risk
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1 events
1 affected
5 at risk
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0 events
0 affected
5 at risk
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1 events
1 affected
5 at risk
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0 events
0 affected
5 at risk
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1 events
1 affected
5 at risk
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0 events
0 affected
5 at risk
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1 events
1 affected
5 at risk
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1 events
1 affected
5 at risk
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0 affected
5 at risk
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0 affected
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0 events
0 affected
5 at risk
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0 events
0 affected
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0 affected
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1 events
1 affected
5 at risk
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0 events
0 affected
5 at risk
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0 events
0 affected
5 at risk
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0 events
0 affected
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0 events
0 affected
5 at risk
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0 affected
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1 events
1 affected
5 at risk
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1 events
1 affected
5 at risk
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0 events
0 affected
5 at risk
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0 affected
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0 affected
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0 affected
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0 affected
5 at risk
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0 affected
5 at risk
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0 affected
5 at risk
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1 events
1 affected
5 at risk
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0 affected
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0 affected
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0 affected
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2 events
2 affected
5 at risk
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0 affected
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2 events
2 affected
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0 affected
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0 affected
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0 affected
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0 affected
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0 affected
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0 events
0 affected
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0 events
0 affected
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3
OG0041
OG0053
OG0066
OG00716
OG0082
OG0098
OG0101
OG0116
OG0126
OG01315
OG0143
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG00716
ParticipantsOG0083
ParticipantsOG0094
ParticipantsOG0100
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG01311
ParticipantsOG0144
Title
Measurements
OG0010
OG0021
OG0033
OG0040
OG0051
OG0063
OG00710
OG0081
OG0093
OG0114
OG0125
OG0138
OG0143
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0041
OG0050
OG0064
OG0077
OG0081
OG0093
OG0101
OG0113
OG0123
OG0136
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01315
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
OG0061
OG0074
OG0081
OG0091
OG0100
OG0111
OG0123
OG0134
OG0140
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0145
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0041
OG0050
OG0060
OG0075
OG0082
OG0090
OG0100
OG0113
OG0124
OG0133
OG0140
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0061
OG0075
OG0081
OG0090
OG0100
OG0113
OG0123
OG0134
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0041
OG0051
OG0066
OG0078
OG0081
OG0097
OG0101
OG0116
OG0125
OG01312
OG0144
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0040
OG0051
OG0065
OG0076
OG0080
OG0095
OG0100
OG0114
OG0121
OG0136
OG0145
4
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00717
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01315
ParticipantsOG0146
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0041
OG0053
OG0061
OG0072
OG0080
OG0093
OG0100
OG0113
OG0123
OG0136
OG0142
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG00717
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG01310
ParticipantsOG0143
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0051
OG0060
OG0071
OG0081
OG0091
OG0101
OG0112
OG0122
OG0133
OG0140
2
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0097
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
OG0062
OG0073
OG0081
OG0090
OG0100
OG0111
OG0122
OG0134
OG0140
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
OG0064
OG0075
OG0081
OG0091
OG0100
OG0113
OG0122
OG0136
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0066
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG01315
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
OG0075
OG0080
OG0092
OG0100
OG0112
OG0123
OG0130
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0040
OG0053
OG0063
OG0074
OG0082
OG0095
OG0101
OG0115
OG0124
OG0137
OG0143
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0041
OG0052
OG0063
OG0074
OG0082
OG0091
OG0101
OG0114
OG0125
OG0138
OG0142
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0001
OG0010
OG0020
OG0033
OG0041
OG0053
OG0063
OG0076
OG0081
OG0094
OG0101
OG0114
OG0122
OG0139
OG0143
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG00717
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0126
ParticipantsOG01310
ParticipantsOG0143
Title
Measurements
OG0001
OG0010
OG0021
OG0032
OG0041
OG0052
OG0061
OG0074
OG0081
OG0093
OG0101
OG0115
OG0122
OG0138
OG0142
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0052
OG0060
OG0072
OG0081
OG0090
OG0101
OG0114
OG0123
OG0131
OG0141
2
OG0040
OG0052
OG0063
OG00713
OG0083
OG0096
OG0101
OG0114
OG0126
OG0139
OG0143
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01315
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0033
OG0041
OG0053
OG0064
OG00711
OG0082
OG0095
OG0101
OG0116
OG0123
OG01310
OG0145
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01315
ParticipantsOG0145
Title
Measurements
OG0000
OG0010
OG0034
OG0040
OG0053
OG0061
OG0076
OG0082
OG0095
OG0100
OG0112
OG0125
OG0133
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0021
OG0034
OG0041
OG0054
OG0064
OG00717
OG0083
OG0094
OG0101
OG0115
OG0127
OG01311
OG0142
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00718
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0117
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0146
Title
Measurements
OG0000
OG0010
OG0021
OG0034
OG0041
OG0053
OG0062
OG0079
OG0083
OG0094
OG0101
OG0113
OG0124
OG0139
OG0143
1
OG0040
OG0051
OG0061
OG0070
OG0080
OG0092
OG0110
OG0122
OG0132
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG00713
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0101
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG01311
ParticipantsOG0142
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
OG0080
OG0092
OG0101
OG0111
OG0120
OG0133
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG00714
ParticipantsOG0083
ParticipantsOG0097
ParticipantsOG0101
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG01311
ParticipantsOG0142
Title
Measurements
OG0001
OG0010
OG0021
OG0033
OG0040
OG0052
OG0063
OG0074
OG0083
OG0093
OG0101
OG0114
OG0122
OG0134
OG0141
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0062
ParticipantsOG00712
ParticipantsOG0081
ParticipantsOG0095
ParticipantsOG0100
ParticipantsOG0113
ParticipantsOG0124
ParticipantsOG0137
ParticipantsOG0141
Title
Measurements
OG0000
OG0010
OG0021
OG0032
OG0041
OG0052
OG0061
OG0075
OG0080
OG0093
OG0110
OG0123
OG0133
OG0141
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
Title
Measurements
OG0050
OG0080
2
OG0040
OG0052
OG0064
OG0078
OG0081
OG0095
OG0101
OG0111
OG0121
OG0138
OG0144
3
OG0041
OG0052
OG0062
OG00710
OG0082
OG0093
OG0100
OG0116
OG0126
OG0138
OG0142
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
OG0131
OG0140
4
OG0041
OG0052
OG0063
OG00715
OG0083
OG0097
OG0101
OG0111
OG0126
OG0137
OG0146
1
OG0040
OG0051
OG0064
OG0073
OG0080
OG0091
OG0100
OG0116
OG0120
OG0138
OG0140
1
OG0041
OG0050
OG0061
OG0071
OG0080
OG0091
OG0101
OG0114
OG0121
OG0134
OG0144
4
OG0041
OG0053
OG0066
OG00717
OG0083
OG0095
OG0101
OG0117
OG0125
OG01312
OG0145
2146.54
± 31.68
OG0043317.10± NAGeometric coefficient of variation could not be calculated for a single participant
OG0052510.55± 71.29
OG0066424.74± 22.42
OG0075918.90± 52.85
OG0083695.32± 62.01
OG0097980.72± 45.28
OG0105944.52± NAGeometric coefficient of variation could not be calculated for a single participant
OG0118394.69± 34.31
OG0125017.96± 44.17
OG01313520.57± 46.29
OG01413688.54± 43.80
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG00717
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG0101
ParticipantsOG0115
ParticipantsOG0127
ParticipantsOG01316
ParticipantsOG0145
Title
Measurements
OG000466.81± NAGeometric coefficient of variation could not be calculated for a single participant
OG0011092.28± NAGeometric coefficient of variation could not be calculated for a single participant
OG0023054.11± NAGeometric coefficient of variation could not be calculated for a single participant
OG0032217.32± 32.55
OG0043465.49± NAGeometric coefficient of variation could not be calculated for a single participant
OG0052546.49± 72.05
OG0066951.06± 25.12
OG0076214.97± 60.67
OG0083874.05± 63.27
OG0098248.45± 47.87
OG0106032.36± NAGeometric coefficient of variation could not be calculated for a single participant
OG0119734.83± 29.60
OG0125114.61± 44.76
OG01314635.17± 52.35
OG01417021.44± 35.37
1908.18
± 27.53
OG0042490.25± NAGeometric coefficient of variation could not be calculated for a single participant
OG0051702.37± 58.17
OG0066271.43± 38.76
OG0073576.49± 30.59
OG008931.02± 53.64
OG0095883.76± 48.48
OG0105188.25± NAGeometric coefficient of variation could not be calculated for a single participant
OG0116892.57± 71.96
OG0122994.24± 37.27
OG0139440.98± 84.11
OG0145296.46± 8.89
7.55
± 73.07
OG00421.20± NAGeometric coefficient of variation could not be calculated for a single participant
OG00513.25± 71.79
OG006107.30± 68.40
OG00750.49± 139.83
OG00829.39± 47.67
OG00937.92± 80.33
OG010129.76± NAGeometric coefficient of variation could not be calculated for a single participant
OG01171.43± 112.42
OG01227.89± 115.67
OG01389.96± 112.80
OG014138.75± 111.14
7.72
± 103.48
OG0048.66± NAGeometric coefficient of variation could not be calculated for a single participant
OG0052.36± 84.21
OG00657.75± 82.69
OG0077.03± 51.10
OG0081.63± 141.42
OG00914.00± 112.58
OG01021.02± NAGeometric coefficient of variation could not be calculated for a single participant
OG01150.89± 123.69
OG0124.64± 73.29
OG01355.63± 163.06
OG01414.96± 64.95
3297.95
± 68.31
OG0093174.42± 40.63
OG0123432.89± 39.76
OG0132901.79± 52.33
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0082
ParticipantsOG0097
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0126
ParticipantsOG0137
ParticipantsOG0140
Title
Measurements
OG0031691.75± 28.96
OG0052013.33± NAGeometric coefficient of variation could not be calculated for a single participant
OG0073684.96± 28.50
OG0084499.65± 72.79
OG0094003.48± 42.09
OG0123908.15± 41.20
OG0134714.85± 48.39
3838.35
± 37.18
OG0095312.66± 45.30
OG0123379.85± 44.24
OG0138534.92± 43.93
361.30
± 54.77
OG009251.73± 49.71
OG012325.42± 47.17
OG013201.02± 56.94
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG00714
ParticipantsOG0083
ParticipantsOG0097
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0126
ParticipantsOG01313
ParticipantsOG0140
Title
Measurements
OG0032.47± 4.29
OG00566.39± NAGeometric coefficient of variation could not be calculated for a single participant
OG00718.17± 116.63
OG00810.83± 161.52
OG00918.45± 71.98
OG01212.66± 108.08
OG01314.17± 99.02
40.88
± 45.39
OG00973.60± 88.34
OG01238.71± 56.34
OG013116.62± 74.25
30.87
± NA
Standard deviation could not be calculated for a single participant
12.50
± NA
Standard deviation could not be calculated for a single participant