Early Bactericidal Activity, Safety & Tolerability of Ora... | NCT05382312 | Trialant
NCT05382312
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jun 17, 2026Actual
Enrollment
127Actual
Phase
Phase 2
Conditions
Tuberculosis
Interventions
GSK3036656
Bedaquiline
Delamanid
RIFAFOUR e-275
BTZ-043
Pretomanid
Linezolid
Moxifloxacin
Countries
South Africa
Protocol Section
Identification Module
NCT ID
NCT05382312
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
214912
Secondary IDs
Not provided
Brief Title
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
Official Title
A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 26, 2022Actual
Primary Completion Date
May 27, 2025Actual
Completion Date
May 27, 2025Actual
First Submitted Date
May 16, 2022
First Submission Date that Met QC Criteria
May 16, 2022
First Posted Date
May 19, 2022Actual
Results Waived
Not provided
Results First Submitted Date
May 20, 2026
Results First Submitted that Met QC Criteria
May 20, 2026
Results First Posted Date
Jun 17, 2026Actual
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
May 20, 2026
Last Update Posted Date
Jun 17, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Name
Class
Click-TB Consortium
UNKNOWN
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or standard of care, for 14 days, in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.
Detailed Description
Not provided
Conditions Module
Conditions
Tuberculosis
Keywords
Early bactericidal activity
Pulmonary tuberculosis
RIFAFOUR
Bedaquiline
Delamanid
GSK3036656
BTZ-043
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
127Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
GSK3036656 + Bedaquiline
Experimental
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Drug: GSK3036656
Drug: Bedaquiline
GSK3036656 + Delamanid
Experimental
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Drug: GSK3036656
Drug: Delamanid
Delamanid + Bedaquiline
Experimental
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Drug: Bedaquiline
Drug: Delamanid
Standard of care for drug-sensitive tuberculosis (DS - TB)_Cohort 1
Experimental
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Drug: RIFAFOUR e-275
GSK3036656 + BTZ-043
Experimental
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3036656
Drug
GSK3036656 was administered.
GSK3036656 + BTZ-043
GSK3036656 + Bedaquiline
GSK3036656 + Delamanid
GSK3036656 + Linezolid
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Time to Sputum Culture Positivity
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
Number of Participants With Serious Adverse Events (SAEs)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants were 18 to 65 years of age inclusive, at the time of signing the informed consent.
Participants had:
A new episode of untreated, rifampicin-susceptible pulmonary tuberculosis (TB)
A chest X-ray picture consistent with pulmonary TB
At least one sputum sample positive on direct microscopy for acid-fast bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease [IUATLD]/World Health Organization [WHO] scale) or positive on a molecular test (at least medium positive for MTB on Xpert MTB/Rif)
A normal echocardiogram, or an echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation, and no valvular stenosis
A creatinine clearance greater than or equal to (>=) 90 mL/minute (Cockcroft-Gault formula)
Male participants were eligible to participate if they agreed to barrier precautions until 90 days after the last dose.
A female participant was eligible to participate if she was not pregnant or breastfeeding and was a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) using a highly effective contraceptive method. A WOCBP had to have a negative urine or serum pregnancy test, as required by local regulations, before the first dose of study intervention. Only participants who were at least 25 years of age, and females of non-childbearing potential, were eligible for the positron emission tomography-computed tomography (PET-CT) assessments.
Participants were capable of giving signed informed consent.
Exclusion Criteria:
There was evidence of a clinically significant condition or abnormality (as judged by the Investigator) (other than the indication being studied) that might have compromised safety or the interpretation of trial efficacy or safety endpoints.
There was clinically significant evidence of extrathoracic TB, as judged by the Investigator.
QTc interval corrected for heart rate by Fridericia's formula (QTcF) was greater than (>) 450 milliseconds (msec).
There was arterial hypertension with systolic BP >=160 mm Hg or diastolic BP >=100 mm Hg. Participants with well-controlled hypertension could be included if they were using amlodipine for the duration of the study.
Participants had vitiligo.
Participants were receiving QT-prolonging drugs, including but not limited to fluoroquinolones, macrolides, and clofazimine.
HIV-infected participants who:
had a cluster of differentiation (CD)4+ count <350 cells/microliters;
had received antiretroviral therapy medication within the last 30 days;
had received oral or intravenous antifungal medication within the last 30 days;
or had an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection or malignancy in the last 12 months (except pulmonary TB).
Hepatitis B surface antigen (HBsAg) was present, or the Hepatitis C antibody test result at screening was positive.
Participants had diabetes (Type 1 or 2), point-of-care glycated hemoglobin (HbA1c) above 6.5%, or random glucose over 11.1 millimoles (mmol)/L.
There were diseases or conditions in which the use of delamanid or bedaquiline was contraindicated.
Participants had abnormal laboratory values at screening, as graded by the enhanced Common Terminology Criteria for Adverse Events (CTCAE version 5, 2017).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Bellville
7530
South Africa
References Module
No data available
No data is available for this block.
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 will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
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.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 127 participants were enrolled out of which 125 started the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
FG001
GSK3036656 + Bedaquiline
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 18, 2024
May 20, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
All laboratory staff involved in analyzing and reporting the microbiological endpoints (logarithm to base10 [log10] colony forming units [CFU] counts and time to sputum culture positivity) were unaware of treatment assignments.
Who Masked
Outcomes Assessor
Drug: GSK3036656
Drug: BTZ-043
Standard of care for DS - TB_Cohort 2
Experimental
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Drug: RIFAFOUR e-275
GSK3036656 + Pretomanid
Experimental
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Drug: GSK3036656
Drug: Pretomanid
GSK3036656 + Linezolid
Experimental
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Drug: GSK3036656
Drug: Linezolid
GSK3036656 + moxifloxacin
Experimental
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Drug: GSK3036656
Drug: Moxifloxacin
Standard of care for DS TB_Cohort 3
Experimental
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Drug: RIFAFOUR e-275
GSK3036656 + Pretomanid
GSK3036656 + moxifloxacin
Bedaquiline
Drug
Bedaquiline was administered.
Delamanid + Bedaquiline
GSK3036656 + Bedaquiline
Delamanid
Drug
Delamanid was administered.
Delamanid + Bedaquiline
GSK3036656 + Delamanid
RIFAFOUR e-275
Drug
RIFAFOUR e-275 was administered.
Standard of care for DS - TB_Cohort 2
Standard of care for DS TB_Cohort 3
Standard of care for drug-sensitive tuberculosis (DS - TB)_Cohort 1
BTZ-043
Drug
BTZ-043 was administered.
GSK3036656 + BTZ-043
Pretomanid
Drug
Pretomanid was administered.
GSK3036656 + Pretomanid
Linezolid
Drug
Linezolid was administered.
GSK3036656 + Linezolid
Moxifloxacin
Drug
Moxifloxacin was administered.
GSK3036656 + moxifloxacin
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment.
From Day 1 to Day 28
Number of Participants With Adverse Events (AE) of Grade 3 Severity or Higher
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not it was considered related to the study intervention. The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1, where grades were defined based on numeric criteria as follows: Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicated greater severity.
Any = occurrence of the event regardless of intensity grade.
From Day 1 to Day 28
Number of Participants With Adverse Events Related to Study Treatment
From Day 1 to Day 28
Number of Participants Withdrawn From the Treatment Due to Adverse Events
From Day 1 to Day 28
Number of Participants Withdrawn From the Study Due to Adverse Events
From Day 1 to Day 28
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PCI ECG values were defined as any ECG findings which, in the opinion of the investigator or medical monitor, would have interfered with the safety of the individual participant. The ECG measurements analyzed were PR Interval, QRS Duration, and QTcF Interval. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
From Day 1 to Day 28
Number of Participants With Hematology Laboratory Values of PCI
The analyzed hematology parameters were hematocrits, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
From Day 1 to Day 28
Number of Participants With Clinical Chemistry Laboratory Values of PCI
The chemistry parameters analyzed were glucose, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, potassium, and sodium. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
From Day 1 to Day 28
Number of Participants With Vital Signs of PCI
The analyzed vital signs were systolic blood pressure, diastolic blood pressure, pulse rate. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
From Day 1 to Day 28
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
FG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
FG003
Delamanid + Bedaquiline
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
FG004
GSK3036656 + BTZ-043
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
FG005
Standard of Care for DS - TB_Cohort 2
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
FG006
GSK3036656 + Pretomanid
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
FG007
GSK3036656 + Linezolid
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
FG008
GSK3036656 + Moxifloxacin
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
FG009
Standard of Care for DS TB_Cohort 3
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
BG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
BG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
BG003
Delamanid + Bedaquiline
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
BG004
GSK3036656 + BTZ-043
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
BG005
Standard of Care for DS - TB_Cohort 2
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
BG006
GSK3036656 + Pretomanid
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
BG007
GSK3036656 + Linezolid
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
BG008
GSK3036656 + Moxifloxacin
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
BG009
Standard of Care for DS TB_Cohort 3
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG00114
BG00215
BG00316
BG00414
BG0053
BG00616
BG00713
BG00814
BG00911
BG010125
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00033.3± 7.79
BG00131.5± 8.70
BG00232.9± 9.01
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ASIAN
Title
Measurements
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
The analysis was performed on the Efficacy Set which included all participants from the Safety Set who provided a baseline and at least one post-baseline evaluable sputum sample. Only participants with data available for the specified analysis time points were included, and all were analysed according to the treatment they actually received.
Posted
Mean
Standard Deviation
log10 CFU/milliliter (mL)
At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
OG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG003
Delamanid + Bedaquiline
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
OG004
GSK3036656 + BTZ-043
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG005
Standard of Care for DS-TB_Cohort 2
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG006
GSK3036656 + Pretomanid
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG007
GSK3036656 + Linezolid
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG008
GSK3036656 + Moxifloxacin
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG009
Standard of Care for DS TB_Cohort 3
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Units
Counts
Participants
OG0009
OG00113
OG00215
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG0009
ParticipantsOG00113
ParticipantsOG00215
ParticipantsOG003
Secondary
Change From Baseline in Time to Sputum Culture Positivity
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
The analysis was performed on the Efficacy Set which included all participants from the Safety Set who provided a baseline and at least one post-baseline evaluable sputum sample. Only participants with data available for the specified analysis time points were included, and all were analysed according to the treatment they actually received.
Posted
Mean
Standard Deviation
log10 hours
At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
OG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Secondary
Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment.
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
OG002
GSK3036656 + Delamanid
Secondary
Number of Participants With Adverse Events (AE) of Grade 3 Severity or Higher
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not it was considered related to the study intervention. The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1, where grades were defined based on numeric criteria as follows: Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicated greater severity.
Any = occurrence of the event regardless of intensity grade.
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Secondary
Number of Participants With Adverse Events Related to Study Treatment
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
OG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG003
Delamanid + Bedaquiline
Secondary
Number of Participants Withdrawn From the Treatment Due to Adverse Events
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
OG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG003
Delamanid + Bedaquiline
Secondary
Number of Participants Withdrawn From the Study Due to Adverse Events
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
OG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
OG003
Delamanid + Bedaquiline
Secondary
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PCI ECG values were defined as any ECG findings which, in the opinion of the investigator or medical monitor, would have interfered with the safety of the individual participant. The ECG measurements analyzed were PR Interval, QRS Duration, and QTcF Interval. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Secondary
Number of Participants With Hematology Laboratory Values of PCI
The analyzed hematology parameters were hematocrits, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Secondary
Number of Participants With Clinical Chemistry Laboratory Values of PCI
The chemistry parameters analyzed were glucose, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, potassium, and sodium. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Secondary
Number of Participants With Vital Signs of PCI
The analyzed vital signs were systolic blood pressure, diastolic blood pressure, pulse rate. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to Day 28
ID
Title
Description
OG000
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
OG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Time Frame
Adverse events and serious AEs were reported from Day 1 to Day 28
Description
Not provided
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
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
0
9
0
9
9
9
EG001
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
0
14
0
14
11
14
EG002
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
0
15
0
15
10
15
EG003
Delamanid + Bedaquiline
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
0
16
0
16
12
16
EG004
GSK3036656 + BTZ-043
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
0
14
0
14
11
14
EG005
Standard of Care for DS - TB_Cohort 2
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
0
3
0
3
1
3
EG006
GSK3036656 + Pretomanid
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
0
16
0
16
12
16
EG007
GSK3036656 + Linezolid
GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
0
13
1
13
8
13
EG008
GSK3036656 + Moxifloxacin
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
0
14
0
14
11
14
EG009
Standard of Care for DS TB_Cohort 3
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
0
11
0
11
9
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Seizure
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG0030 events0 affected16 at risk
EG0040 events0 affected14 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected16 at risk
EG0071 events1 affected13 at risk
EG0080 events0 affected14 at risk
EG0090 events0 affected11 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected15 at risk
EG0031 events1 affected16 at risk
EG0040 events0 affected14 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected16 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected14 at risk
EG0090 events0 affected11 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Rhythm idioventricular
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dry eye
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Eye irritation
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0013 events3 affected14 at risk
EG0023 events3 affected15 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Post-tussive vomiting
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Body tinea
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gingivitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Periodontitis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Tuberculous pleurisy
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Electrocardiogram PR prolongation
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected14 at risk
EG0023 events3 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0003 events3 affected9 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected14 at risk
EG0023 events3 affected15 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0005 events4 affected9 at risk
EG0012 events2 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hot flush
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.