Investigation of GSK2879552 in Subjects With Relapsed/Ref... | NCT02034123 | Trialant
NCT02034123
Sponsor
GlaxoSmithKline
Status
Terminated
Last Update Posted
Dec 6, 2019Actual
Enrollment
29Actual
Phase
Phase 1
Conditions
Carcinoma, Small Cell
Interventions
GSK2879552
Countries
United States
France
Spain
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02034123
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
200858
Secondary IDs
ID
Type
Description
Link
2013-003451-38
EudraCT Number
Brief Title
Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma
Official Title
A Phase I Open-label, Dose Escalation Study to Investigate The Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2879552 Given Orally in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The risk benefit in relapsed refractory SCLC does not favor continuation of the study
Expanded Access Info
No
Start Date
Feb 4, 2014Actual
Primary Completion Date
Apr 18, 2017Actual
Completion Date
Apr 18, 2017Actual
First Submitted Date
Dec 5, 2013
First Submission Date that Met QC Criteria
Jan 9, 2014
First Posted Date
Jan 13, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 12, 2018
Results First Submitted that Met QC Criteria
Jul 13, 2018
Results First Posted Date
Jan 23, 2019Actual
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
Nov 19, 2019
Last Update Posted Date
Dec 6, 2019Actual
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
GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase 1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity. This is a phase I, open-label, multi-center, non-randomized, 2-part first time in human (FTIH) study for GSK2879552. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for GSK2879552 based on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles observed after oral administration of GSK2879552. Any dose level(s) may be expanded up to 12 subjects in order to collect additional data on PK and PD.The safety and PK/PD data will be reviewed prior to the dose decision, and the dose escalation will be guided by the Neuenschwander -continuous reassessment method (N-CRM). Built-in safety constraints are in place to prevent exposing subjects to undue risk of toxicity. Once RP2D is identified, an expansion cohort (Part 2) of up to 30 subjects will be enrolled to further evaluate the clinical activity and tolerability of GSK2879552 in subjects with relapsed/refractory SCLC.
Detailed Description
Not provided
Conditions Module
Conditions
Carcinoma, Small Cell
Keywords
First time in humans
Small cell lung carcinoma
Oncology
GSK2879552
LSD1 inhibitor
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
29Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Escalation Cohort
Experimental
The safety and PK/PD data will be reviewed prior to the dose decision, and the dose escalation will be guided by the Neuenschwander -continuous reassessment method (N-CRM).The dose escalation will complete when RP2D is determined. The RP2D will be the MTD or a lower dose that provides adequate PK exposure and biologic activity with superior tolerability.
Drug: GSK2879552
Dose Expansion Cohort
Experimental
Once the RP2D has been determined, an expansion cohort of up to 30 subjects will be enrolled in order to better characterize the clinical activity and safety profile of the RP2D
Drug: GSK2879552
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK2879552
Drug
Subjects will receive GSK2879552orally with approximately 200 milliliter (mL) of water.
Dose Escalation Cohort
Dose Expansion Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Treated Population which included all participants who received at least one dose of study treatment.
Median of 7.286 weeks of drug exposure
Part 1: Number of Participants With Dose Limiting Toxicities (DLT)
An event was considered a DLT if it occurs within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity.
Median of 7.286 weeks of drug exposure
Part 1: Number of Participants With Dose Reduction or Delays
The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.
Median of 7.286 weeks of drug exposure
Part 1: Number of Participants Withdrawn Due to Toxicities
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provided signed written informed consent
Males and females >=18 years of age (at the time consent is obtained).
Histologically or cytologically confirmed diagnosis of small cell lung carcinoma. Subjects must have measurable disease per RECIST 1.1 (for Part 2 only).
Recurrent or refractory disease after receiving at least one prior standard/approved platinum-containing chemotherapy regimen, or where standard therapy is refused. Part 2 only: Subjects must have recurrent disease after receiving a maximum of two prior chemotherapy regimens including at least one platinum containing regimen.
Eastern Cooperative Oncology Group (ECOG) performance status of <= 1. (ECOG performance status of 0 or 1).
Tumor tissue requirements: Availability of archival tissue, or willingness to undergo fresh biopsy at baseline; Enrollment in PK/PD cohort may be limited to subjects with disease amenable to pre- and post-dose biopsies, and willingness to undergo biopsy.
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia)
Adequate baseline organ function
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, as defined in protocol, during the study and for 7 days following the last dose of study treatment.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in protocol from the administration of the first dose of study treatment until 3 months after the last dose of study treatment to allow for clearance of any altered sperm.
Able to swallow and retain orally administered study treatment and does not have any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion Criteria:
Concurrent malignancy other than SCLC. History of other malignancy is allowed as long as there is no evidence of active disease or need for treatment.
Currently receiving anti-cancer therapy. Exceptions: Zoledronic acid and denosumab to treat bone metastasis are allowed.
Prior treatment with temozolomide, dacarbazine or procarbazine.
Baseline Montreal Cognitive Assessment (MOCA) score of 22 or lower.
Received major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK2879552 administration. Chemotherapy regimens with delayed toxicity within the last four weeks (six weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity or palliative radiation to a limited area within the last two weeks.
Administration of an investigational drug within 28 days or 5 half-lives, whichever is shorter preceding the first dose of study treatment(s) in this study.
French subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous 28 days.
Subjects with current/a history of bleeding disorder or coagulopathy or who are at particularly high risk for bleeding complications.
Requiring anticoagulants at therapeutic doses or platelet inhibitor.
Current use of a prohibited medication or expected to require any of these medications during treatment with the investigational drug
Evidence of severe or uncontrolled systemic diseases. Any serious and/or unstable pre-existing medical, 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
Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infections. Subjects with laboratory evidence of HBV clearance may be enrolled
Leptomeningeal metastases or spinal cord compression due to disease.
Subjects with previously untreated or uncontrolled brain metastases.
Cardiac abnormalities
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2879552 or LSD1 inhibitors that contraindicates their participation.
Lactating female
Consumption of Seville oranges, grapefruit, grapefruit hybrids, grapefruit juice, pommelos, or exotic citrus fruits, from 1 day prior to the first dose of study treatment(s) until the last dose of study drug.
Bauer TM, Besse B, Martinez-Marti A, Trigo JM, Moreno V, Garrido P, Ferron-Brady G, Wu Y, Park J, Collingwood T, Kruger RG, Mohammad HP, Ballas MS, Dhar A, Govindan R. Phase I, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2879552 in Relapsed/Refractory SCLC. J Thorac Oncol. 2019 Oct;14(10):1828-1838. doi: 10.1016/j.jtho.2019.06.021. Epub 2019 Jun 28.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
This study was terminated early during Part 1 as the risk benefit in relapsed refractory SCLC did not favor continuation of the study. Data was collected only in Part 1 and no participants were enrolled in Part 2. A total of 29 participants enrolled and received treatment in Part 1. Of which 7 prematurely withdrawn and 22 completed study.
Recruitment Details
This was planned as a 2-part, first time in human study in participants with relapsed/refractory small cell lung carcinoma. Part 1 was a dose escalation cohort and Part 2 was an expansion cohort. Participants were planned to receive GSK2879552 at a starting dose of 0.25 milligrams (mg) once daily for 28 days.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
FG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
FG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
FG009
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG010
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG011
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG012
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG013
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG014
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
FG015
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
FG016
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
FG017
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Periods
Title
Milestones
Reasons Not Completed
Part1(Median of 7.286 Weeks of Exposure)
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0033 subjects
FG004
COMPLETED
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part2(Up to 2 Years)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Data was collected only in Part 1 and no participants were enrolled in Part 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG001
Part 1:GSK2879552 0.5 mg Daily
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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 Serious Adverse Events (SAEs) and Non-SAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Treated Population which included all participants who received at least one dose of study treatment.
All Treated Population
Posted
Number
Participants
Median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Adverse Events Module
Frequency Threshold
5
Time Frame
Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure.
Description
SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
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
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.
Median of 7.286 weeks of drug exposure
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Blood samples were collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, alanine aminotransferase (ALT), uric acid, glucose, gamma glutamyl transferase (GGT), albumin, sodium, calcium, alkaline phosphatase, and phosphorus, inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in clinical chemistry parameters have been presented. The clinical chemistry parameters for which any grade increase worst-case on-therapy value was reported have been only summarized. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Baseline and median of 7.286 weeks of drug exposure
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline
Blood samples were collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented. The hematology parameters for which any grade increase worst-case on-therapy value was reported have been only summarized.
Baseline and median of 7.286 weeks of drug exposure
Part 1:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. Vital signs were measured after resting for at least 5 minutes in a semi-supine position. The number of participants with critical changes in values of vital signs in response to drug have been presented.
Median of 7.286 weeks of drug exposure
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters
Single measurements of 12-lead ECGs were obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. The number of participants with abnormal - not clinically significant and abnormal - clinically significant "worst-case on-therapy" value have been presented.
Median of 7.286 weeks of drug exposure
Part 1: Number of Participants With Abnormal Findings Undergoing Physical Examinations
The complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination included assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). All abnormal physical examination findings were reported as AEs within the AE specific case report form (CRF) page. Hence, data was not captured separately for this outcome as number of participants with abnormal findings with respect to physical examinations. NA indicates data was not available as all abnormal physical examination findings were reported as AEs.
Median of 7.286 weeks of drug exposure
Part 2: Number of Participants Achieving Disease Control Rate at Week 16
Clinical response was planned to be assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at Week 16. Disease control rate was defined as number of participants achieving complete response (CR), partial response (PR) and stable disease (SD) per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Week 16
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following single (Day 1) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1
Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 15
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including Cmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including Tmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including lambda z following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552 . Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including T1/2 following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
Part 1: Accumulation Ratio Following Administration of GSK2879552
The accumulation ratio was analyzed using analysis of variance (ANOVA) for AUC (0-tau) on Day 15 versus AUC (0-tau) on Day 1 by dose cohort. Only dose cohorts with repeat daily dosing were analyzed. The observed accumulation ratio (Ro) was determined based on AUC data to estimate the extent of accumulation after repeat dosing. The Ro of GSK2879552 was estimated by calculating the ratio of the geometric least squares (GLS) means of the pharmacokinetic parameter between Day 15 and Day 1 for all dose levels and the corresponding 90 percent confidence interval (CI) for each ratio.
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
Part 1: Time Invariance Ratio Following Administration of GSK2879552
Time invariance was assessed to evaluate whether the pharmacokinetics remains unaltered after repeat dosing. The mixed effect model was fitted with day as a fixed effect and participant as a random effect for each treatment (dose) separately. AUC (0-tau) on Day 15 was compared to AUC (0-infinity) on Day 1 in order to assess time invariance for each dose. The ratio and 90 percent CI were calculated by back-transforming the difference between the LS means for the two days and associated 90 percent CI, for each dose. Only dose cohorts with repeat daily dosing were analyzed.
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
Part 1: Number of Participants Achieving Disease Control Rate at Week 16
The clinical activity of GSK2879552 given orally in participants with SCLC was evaluated by assessing disease control rate. Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate (CR+PR+SD) based on RECIST version 1.1 at Week 16. Disease control rate was defined as number of participants achieving CR, PR and SD per RECIST version 1.1. The number of participants achieving disease control rate have been presented.
Week 16
Part 1 :Median Effective Dose (ED50) of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Estimates and standard error have been presented.
Baseline and median of 7.286 weeks of drug exposure
Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.
Baseline and median of 7.286 weeks of drug exposure
Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.
Baseline and median of 7.286 weeks of drug exposure
Part 2: Number of Participants With SAEs and Non-SAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Number of Participants With DLTs
An event was considered a DLT if it occured within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Number of Participants With Dose Reduction or Delays
The number of participants who had any dose reduction or delay were planned to be analyzed. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Number of Participants Withdrawn Due to Toxicities
Participants were planned to be monitored from start of the study till the development of toxicity in Part 2. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Blood samples were planned to be collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, ALT, uric acid, glucose, GGT, albumin, sodium, calcium, alkaline phosphatase, and phosphorus inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Baseline and up to 2 years
Part 2: Number of Participants With Change in Hematology Toxicity Grade From Baseline
Blood samples were planned to be collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Baseline and up to 2 years
Part 2:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Vital sign measurement includes SBP, DBP, temperature, respiration rate and heart rate. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Number of Participants With Abnormal Findings for ECG Parameters
Single measurements of 12-lead ECGs were planned to be obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Number of Participants With Abnormal Findings Undergoing Physical Examinations
The complete physical examination includes assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination includes assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Clearance Following Administration of GSK2879552
Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including clearance. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48
Part 2: Volume of Distribution Following Administration of GSK2879552
Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including volume of distribution. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48
Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Baseline and up to 2 years
Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Baseline and up to 2 years
Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Baseline and Up to 2 years
Part 2: Duration of Response
Duration of response for participants is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Progression Free Survival (PFS)
PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Part 2: Percentage of Participants Achieving CR and PR
Overall response rate is defined as percentage of participants achieving CR and PR per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 2 years
Columbus
Ohio
43210
United States
GSK Investigational Site
Nashville
Tennessee
37203
United States
GSK Investigational Site
Villejuif
94805
France
GSK Investigational Site
Barcelona
08035
Spain
GSK Investigational Site
Madrid
28034
Spain
GSK Investigational Site
Madrid
28040
Spain
GSK Investigational Site
Málaga
29010
Spain
7 subjects
FG0053 subjects
FG0062 subjects
FG0075 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
5 subjects
FG0053 subjects
FG0062 subjects
FG0074 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Other-Study closed/terminated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
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
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
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
FG0150 subjects
FG0160 subjects
FG0170 subjects
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
BG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
BG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
BG009
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG010
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG011
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG012
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG013
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG014
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
BG015
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
BG016
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
BG017
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
BG018
Total
Total of all reporting groups
1
BG0011
BG0025
BG0033
BG0047
BG0053
BG0062
BG0075
BG0082
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG01829
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00078.0± NANA indicates data was not available due to insufficient number of participants to calculate standard deviation.
BG00147.0± NANA indicates data was not available due to insufficient number of participants to calculate standard deviation.
BG00263.8± 4.09
BG00356.7± 8.08
BG00462.4± 7.41
BG00560.3± 7.51
BG00653.5± 13.44
BG00758.8± 10.33
BG00861.5± 9.19
BG01860.6± 8.58
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG0021
BG0030
BG0041
BG0052
BG0061
BG0073
BG0081
BG01811
Male
BG0000
BG0010
BG0024
BG0033
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
African American/African Heritage
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0181
White-White/Caucasian/European Heritage
BG0001
BG0011
BG0025
BG0033
BG004
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0033
OG0047
OG0053
OG0062
OG0075
OG0082
Title
Denominators
Categories
Any non-SAE
Title
Measurements
OG0001
OG0011
OG0025
OG0032
OG0046
OG0053
OG0062
OG0075
OG0081
Any SAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLT)
An event was considered a DLT if it occurs within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity.
All Treated Population
Posted
Number
Participants
Median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Number of Participants With Dose Reduction or Delays
The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.
All Treated Population
Posted
Number
Participants
Median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG003
Primary
Part 1: Number of Participants Withdrawn Due to Toxicities
Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.
All Treated Population
Posted
Number
Participants
Median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Blood samples were collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, alanine aminotransferase (ALT), uric acid, glucose, gamma glutamyl transferase (GGT), albumin, sodium, calcium, alkaline phosphatase, and phosphorus, inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in clinical chemistry parameters have been presented. The clinical chemistry parameters for which any grade increase worst-case on-therapy value was reported have been only summarized. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
All Treated Population
Posted
Number
Participants
Baseline and median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Albumin;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG003
Primary
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline
Blood samples were collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented. The hematology parameters for which any grade increase worst-case on-therapy value was reported have been only summarized.
All Treated Population. Only those participants with data available at specific time point were analyzed.
Posted
Number
Participants
Baseline and median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Hemoglobin
Title
Measurements
OG0001
OG0010
OG0023
OG003
Primary
Part 1:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. Vital signs were measured after resting for at least 5 minutes in a semi-supine position. The number of participants with critical changes in values of vital signs in response to drug have been presented.
All Treated Population
Posted
Number
Participants
Median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters
Single measurements of 12-lead ECGs were obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. The number of participants with abnormal - not clinically significant and abnormal - clinically significant "worst-case on-therapy" value have been presented.
All Treated Population. Only those participants with data available at specific time point were analyzed.
Posted
Number
Participants
Median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Abnormal - not clinically significant
Title
Measurements
OG0000
OG0011
OG0024
OG003
Primary
Part 1: Number of Participants With Abnormal Findings Undergoing Physical Examinations
The complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination included assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). All abnormal physical examination findings were reported as AEs within the AE specific case report form (CRF) page. Hence, data was not captured separately for this outcome as number of participants with abnormal findings with respect to physical examinations. NA indicates data was not available as all abnormal physical examination findings were reported as AEs.
All Treated Population
Posted
Number
Participants
Median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG000NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG001NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG002
Primary
Part 2: Number of Participants Achieving Disease Control Rate at Week 16
Clinical response was planned to be assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at Week 16. Disease control rate was defined as number of participants achieving complete response (CR), partial response (PR) and stable disease (SD) per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Week 16
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*Nanogram per milliliter
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Day 1; n=1, 1, 5, 3, 7, 3, 2, 5, 2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG003
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following single (Day 1) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.
Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*Nanogram per milliliter
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG00014.5± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00127.2± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG002
Secondary
Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.
Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*Nanogram per milliliter
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG00027.3± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00140.3± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG002
Secondary
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including Cmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Day 1; n=1, 1, 5, 3, 7, 3, 2, 5, 2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG003
Secondary
Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including Tmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Day 1; n=1, 1, 5, 3, 7, 3, 2, 5, 2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG003
Secondary
Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including lambda z following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552 . Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours^-1
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Day 1; n= 1, 1, 5, 3, 6, 3, 2, 5, 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG003
Secondary
Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2879552
Blood samples were collected from participants for pharmacokinetic analysis including T1/2 following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Pharmacokinetic Population
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Day 1; n=1, 1, 5, 3, 6, 3, 2, 5, 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG003
Secondary
Part 1: Accumulation Ratio Following Administration of GSK2879552
The accumulation ratio was analyzed using analysis of variance (ANOVA) for AUC (0-tau) on Day 15 versus AUC (0-tau) on Day 1 by dose cohort. Only dose cohorts with repeat daily dosing were analyzed. The observed accumulation ratio (Ro) was determined based on AUC data to estimate the extent of accumulation after repeat dosing. The Ro of GSK2879552 was estimated by calculating the ratio of the geometric least squares (GLS) means of the pharmacokinetic parameter between Day 15 and Day 1 for all dose levels and the corresponding 90 percent confidence interval (CI) for each ratio.
Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.
Posted
Number
90% Confidence Interval
Ratio of AUC
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Units
Counts
Participants
OG0005
OG0014
Title
Denominators
Categories
Title
Measurements
OG0001.917(1.426 to 2.578)
OG0011.652(1.484 to 1.840)
Secondary
Part 1: Time Invariance Ratio Following Administration of GSK2879552
Time invariance was assessed to evaluate whether the pharmacokinetics remains unaltered after repeat dosing. The mixed effect model was fitted with day as a fixed effect and participant as a random effect for each treatment (dose) separately. AUC (0-tau) on Day 15 was compared to AUC (0-infinity) on Day 1 in order to assess time invariance for each dose. The ratio and 90 percent CI were calculated by back-transforming the difference between the LS means for the two days and associated 90 percent CI, for each dose. Only dose cohorts with repeat daily dosing were analyzed.
Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.
Posted
Number
90% Confidence Interval
Ratio of AUC
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Units
Counts
Participants
OG0005
OG0015
OG0023
Title
Denominators
Categories
Title
Measurements
OG0001.332(1.112 to 1.596)
OG0011.206(1.027 to 1.417)
OG0020.688(0.412 to 1.149)
Secondary
Part 1: Number of Participants Achieving Disease Control Rate at Week 16
The clinical activity of GSK2879552 given orally in participants with SCLC was evaluated by assessing disease control rate. Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate (CR+PR+SD) based on RECIST version 1.1 at Week 16. Disease control rate was defined as number of participants achieving CR, PR and SD per RECIST version 1.1. The number of participants achieving disease control rate have been presented.
All Treated Population.
Posted
Number
Participants
Week 16
ID
Title
Description
OG000
Part 1:GSK2879552 0.25 mg Daily
Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG003
Secondary
Part 1 :Median Effective Dose (ED50) of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Estimates and standard error have been presented.
Pharmacokinetic Population
Posted
Mean
Standard Error
Milligrams
Baseline and median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1: Participants With Repeat Daily Dosing
Participants received repeat daily dosing with GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were escalated to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
Units
Counts
Participants
OG00029
Title
Denominators
Categories
Title
Measurements
OG0001.7444± 0.1436
Secondary
Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.
Pharmacokinetic Population
Posted
Mean
Standard Error
Nanogram per milliliter
Baseline and median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1: Participants With Repeat Daily Dosing
Participants received repeat daily dosing with GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were escalated to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
Units
Counts
Participants
OG00029
Title
Denominators
Categories
Title
Measurements
OG00010.3948± 1.2666
Secondary
Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.
Pharmacokinetic Population
Posted
Mean
Standard Error
Hour*Nanogram per milliliter
Baseline and median of 7.286 weeks of drug exposure
ID
Title
Description
OG000
Part 1: Participants With Repeat Daily Dosing
Participants received repeat daily dosing with GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were escalated to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
Units
Counts
Participants
OG00029
Title
Denominators
Categories
Title
Measurements
OG00081.8512± 6.0391
Secondary
Part 2: Number of Participants With SAEs and Non-SAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Number of Participants With DLTs
An event was considered a DLT if it occured within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Number of Participants With Dose Reduction or Delays
The number of participants who had any dose reduction or delay were planned to be analyzed. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Number of Participants Withdrawn Due to Toxicities
Participants were planned to be monitored from start of the study till the development of toxicity in Part 2. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Blood samples were planned to be collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, ALT, uric acid, glucose, GGT, albumin, sodium, calcium, alkaline phosphatase, and phosphorus inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Baseline and up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Number of Participants With Change in Hematology Toxicity Grade From Baseline
Blood samples were planned to be collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Baseline and up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Vital sign measurement includes SBP, DBP, temperature, respiration rate and heart rate. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Number of Participants With Abnormal Findings for ECG Parameters
Single measurements of 12-lead ECGs were planned to be obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Number of Participants With Abnormal Findings Undergoing Physical Examinations
The complete physical examination includes assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination includes assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Clearance Following Administration of GSK2879552
Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including clearance. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Posted
Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Volume of Distribution Following Administration of GSK2879552
Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including volume of distribution. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Posted
Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Posted
Baseline and up to 2 years
ID
Title
Description
OG000
Part 2 :Participants With Repeat Daily Dosing
Participants with repeat daily dosing were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were planned to escalate to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
Units
Counts
Participants
OG0000
Secondary
Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Posted
Baseline and up to 2 years
ID
Title
Description
OG000
Part 2 :Participants With Repeat Daily Dosing
Participants with repeat daily dosing were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were planned to escalate to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
Units
Counts
Participants
OG0000
Secondary
Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)
The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Posted
Baseline and Up to 2 years
ID
Title
Description
OG000
Part 2 :Participants With Repeat Daily Dosing
Participants with repeat daily dosing were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily for 28 days. The doses were planned to escalate to receive either 0.25 mg or 0.5 or 1 mg or 1.5 or 2 mg or 3 mg daily for 28 days.
Units
Counts
Participants
OG0000
Secondary
Part 2: Duration of Response
Duration of response for participants is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Progression Free Survival (PFS)
PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Part 2: Percentage of Participants Achieving CR and PR
Overall response rate is defined as percentage of participants achieving CR and PR per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Posted
Up to 2 years
ID
Title
Description
OG000
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG001
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG002
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG003
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG004
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG005
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
OG006
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
OG007
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
OG008
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
0
1
0
1
1
1
EG001
Part 1:GSK2879552 0.5 mg Daily
Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
1
0
1
1
1
EG002
Part 1:GSK2879552 1.0 mg Daily
Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
5
0
5
5
5
EG003
Part 1:GSK2879552 1.5 mg Daily
Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
3
2
3
2
3
EG004
Part 1: GSK2879552 2.0 mg Daily
Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
1
7
2
7
6
7
EG005
Part 1: GSK2879552 3.0 mg Daily
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
3
1
3
3
3
EG006
Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
0
2
0
2
2
2
EG007
Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
0
5
2
5
5
5
EG008
Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
1
2
2
2
1
2
EG009
Part 2:GSK2879552 0.25 mg Daily
Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
0
0
0
0
0
EG010
Part 2:GSK2879552 0.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
0
0
0
0
0
EG011
Part 2:GSK2879552 1.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
0
0
0
0
0
EG012
Part 2:GSK2879552 1.5 mg Daily
Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
0
0
0
0
0
EG013
Part 2: GSK2879552 2.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
0
0
0
0
0
EG014
Part 2: GSK2879552 3.0 mg Daily
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
0
0
0
0
0
0
EG015
Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.
0
0
0
0
0
0
EG016
Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
0
0
0
0
0
0
EG017
Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off
Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
0
0
0
0
0
0
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Malaise
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Myocardial infarction
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Pericardial effusion
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0047 events5 affected7 at risk
EG0058 events3 affected3 at risk
EG0062 events1 affected2 at risk
EG0073 events2 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected5 at risk
EG0030 events0 affected3 at risk
EG0044 events2 affected7 at risk
EG0052 events2 affected3 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0022 events2 affected5 at risk
EG0031 events1 affected3 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0043 events3 affected7 at risk
EG0053 events1 affected3 at risk
EG0061 events1 affected2 at risk
EG0073 events2 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected3 at risk
EG0062 events2 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0023 events3 affected5 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0082 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0052 events2 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0044 events3 affected7 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events3 affected5 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0052 events1 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0072 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dysgeusia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
White blood cell count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Acidosis
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Amnesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Anxiety
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Blood uric acid increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Confusional state
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Coordination abnormal
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 affected0 at risk
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Disorientation
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Dysuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Epilepsy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Flushing
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hypertension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0073 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Infected bite
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Lethargy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Lip dry
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0054 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Mucosal inflammation
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Presyncope
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Rectal prolapse
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Restless legs syndrome
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Somnolence
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Superior vena cava syndrome
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Testicular pain
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Tremor
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Weight decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
Xerosis
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected2 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected0 at risk
EG0100 events0 affected0 at risk
EG0110 events0 affected0 at risk
EG0120 events0 affected0 at risk
EG0130 events0 affected0 at risk
EG0140 events0 affected0 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected0 at risk
EG0170 events0 affected0 at risk
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.
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
6
BG0051
BG0061
BG0072
BG0081
BG01818
7
BG0053
BG0061
BG0075
BG0082
BG01828
2
OG0042
OG0051
OG0060
OG0072
OG0082
3
OG0047
OG0053
OG0062
OG0075
OG0082
0
OG0041
OG0053
OG0060
OG0071
OG0080
3
OG0047
OG0053
OG0062
OG0075
OG0082
0
OG0043
OG0053
OG0061
OG0070
OG0080
3
OG0047
OG0053
OG0062
OG0075
OG0082
0
OG0041
OG0050
OG0060
OG0071
OG0081
3
OG0047
OG0053
OG0062
OG0075
OG0082
3
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0010
OG0024
OG0030
OG0040
OG0050
OG0060
OG0072
OG0081
Alkaline Phosphatase;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0024
OG003
ALT;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0010
OG0022
OG003
AST;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0010
OG0023
OG003
Total Bilirubin;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0021
OG003
Calcium;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0022
OG003
Calcium (hypercalcemia);n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0022
OG003
Calcium (hypocalcemia);n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0021
OG003
GGT;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0011
OG0024
OG003
Glucose;n=1,1,5,3,6,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0046
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0011
OG0022
OG003
Glucose (hyperglycemia);n=1,1,5,3,6,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0046
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0011
OG0022
OG003
Glucose (hypoglycemia);n=1,1,5,3,6,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0046
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium;n=1,1,5,2,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0032
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0010
OG0022
OG003
Potassium (hyperkalemia);n=1,1,5,2,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0032
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0021
OG003
Potassium (hypokalemia);n=1,1,5,2,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0032
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0001
OG0010
OG0021
OG003
Sodium;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0023
OG003
Sodium (hypernatremia);n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium (hyponatremia);n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0023
OG003
Phosphorus, inorganic;n=1,1,5,3,5,3,2,5,2
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000
OG0010
OG0023
OG003
Uric acid;n=0,0,1,0,0,1,0,0,1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
Title
Measurements
OG0021
OG0051
OG0081
3
OG0046
OG0053
OG0062
OG0075
OG0082
2
OG0044
OG0052
OG0060
OG0073
OG0081
Hemoglobin (Increased)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Hemoglobin (Anemia)
Title
Measurements
OG0001
OG0010
OG0023
OG0032
OG0044
OG0052
OG0060
OG0073
OG0081
Lymphocytes
Title
Measurements
OG0000
OG0010
OG0023
OG0032
OG0042
OG0052
OG0061
OG0074
OG0081
Lymphocytes (Increased)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Lymphocytes (Decreased)
Title
Measurements
OG0000
OG0010
OG0023
OG0032
OG0042
OG0052
OG0061
OG0074
OG0081
Total Neutrophils
Title
Measurements
OG0001
OG0010
OG0022
OG0030
OG0042
OG0052
OG0062
OG0071
OG0080
Platelet count
Title
Measurements
OG0001
OG0010
OG0023
OG0031
OG0045
OG0053
OG0061
OG0074
OG0080
WBC count
Title
Measurements
OG0001
OG0010
OG0022
OG0030
OG0042
OG0053
OG0062
OG0073
OG0080
3
OG0047
OG0053
OG0062
OG0075
OG0082
0
OG0040
OG0050
OG0060
OG0070
OG0080
3
OG0045
OG0053
OG0062
OG0075
OG0081
1
OG0044
OG0051
OG0061
OG0075
OG0081
Abnormal - clinically significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0050
OG0060
OG0070
OG0080
3
OG0047
OG0053
OG0062
OG0075
OG0082
NA
NA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG003NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG004NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG005NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG006NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG007NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
OG008NANA indicates data was not available as all abnormal physical examination findings were reported as AEs.
0
OG0040
OG0050
OG0060
OG0070
OG0080
3
OG0047
OG0053
OG0062
OG0075
OG0082
3
ParticipantsOG0047
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG00010.4± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00121.6± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00232.4± 15.7
OG00360.8± 13.8
OG00486.0± 57.6
OG005190.0± 29.6
OG006148.0± 29.9
OG007155.2± 29.0
OG008129.1± 26.2
Day 15; n=1, 1, 5, 1, 5, 3,2, 5,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0080
Title
Measurements
OG00027.0± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00140.7± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00253.6± 31.5
OG003
3
OG0046
OG0053
OG0062
OG0075
OG0081
40.0
± 18.7
OG00370.7± 15.0
OG004108.6± 56.1
OG005206.3± 27.7
OG006163.6± 25.3
OG007182.9± 27.1
OG008180.9± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
1
OG0045
OG0053
OG0062
OG0074
OG0080
53.3
± 31.2
OG00391.1± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG004143.8± 64.2
OG005141.9± 32.4
OG006164.7± 8.2
OG007203.4± 37.2
3
OG0047
OG0053
OG0062
OG0075
OG0082
3
ParticipantsOG0047
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0003.8± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0012.9± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0026.4± 17.3
OG0039.3± 12.2
OG00412.9± 36.6
OG00522.0± 42.9
OG00631.2± 26.8
OG00723.9± 20.8
OG00823.4± 68.8
Day 15; n=1, 1, 5, 1, 5, 3, 2, 5, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0080
Title
Measurements
OG0003.4± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0014.3± NANA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0026.9± 29.2
OG003
3
OG0047
OG0053
OG0062
OG0075
OG0082
3
ParticipantsOG0047
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0082
Title
Measurements
OG0000.5± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0011.5± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0020.5± 2.8
OG0031.3± 110.4
OG0040.8± 108.5
OG0051.6± 42.5
OG0060.8± 85.8
OG0071.2± 52.6
OG0080.7± 52.1
Day 15; n=1, 1, 5, 1, 5, 3, 2, 5, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0080
Title
Measurements
OG0001.0± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0011.5± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0020.9± 65.1
OG003
3
OG0047
OG0053
OG0062
OG0075
OG0082
3
ParticipantsOG0046
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0081
Title
Measurements
OG0000.0± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0010.0± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG0020.0± 62.6
OG0030.1± 8.7
OG0040.0± 8.7
OG0050.0± 19.1
OG0060.1± 47.9
OG0070.1± 23.2
OG0080.1± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
Day 15; n=0,0,0,0, 0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
3
OG0047
OG0053
OG0062
OG0075
OG0082
3
ParticipantsOG0046
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0081
Title
Measurements
OG00016.9± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00124.0± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00217.3± 62.6
OG0038.8± 8.7
OG00418.1± 8.7
OG00515.4± 19.1
OG00611.5± 47.9
OG0078.9± 23.2
OG0088.4± NANA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
Day 15; n=0,0,0,0, 0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
3
OG0047
OG0053
OG0062
OG0075
OG0082
0
OG0041
OG0051
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0051
OG0061
OG0072
OG0080
0
OG0041
OG0051
OG0061
OG0072
OG0081
0
OG0040
OG0052
OG0061
OG0072
OG0081
0
OG0040
OG0051
OG0060
OG0070
OG0080
0
OG0040
OG0051
OG0061
OG0071
OG0080
0
OG0040
OG0051
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0061
OG0070
OG0080
1
OG0042
OG0051
OG0061
OG0070
OG0081
1
OG0042
OG0053
OG0061
OG0072
OG0081
1
OG0044
OG0051
OG0061
OG0073
OG0081
1
OG0044
OG0051
OG0061
OG0073
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0041
OG0051
OG0060
OG0072
OG0080
0
OG0041
OG0050
OG0060
OG0071
OG0080
0
OG0041
OG0051
OG0060
OG0072
OG0080
0
OG0042
OG0051
OG0061
OG0071
OG0080
0
OG0041
OG0050
OG0060
OG0070
OG0080
0
OG0041
OG0051
OG0061
OG0071
OG0080
0
OG0042
OG0050
OG0060
OG0071
OG0080
91.1
± NA
NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG004144.1± 64.6
OG005122.1± 30.4
OG006164.1± 7.8
OG007184.4± 40.4
13.8
± NA
NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
OG00415.7± 39.4
OG00515.2± 23.1
OG00624.4± 21.5
OG00728.1± 7.7
0.5
± NA
NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.