Asthma
Conditions
Keywords
Severe asthma, Safety, GSK3772847, Efficacy
Brief summary
GSK3772847, an anti-interleukin (IL)33 receptor monoclonal antibody, is a novel treatment for asthma. This is a phase 2a study which aims to evaluate efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in subjects with moderately severe asthma. The study will be conducted in 4 phases including screening, run-in phase, treatment phase and follow-up. In treatment phase, eligible subjects will be randomized to receive either GSK3772847 or placebo administered via intravenous (IV) route every 4 weeks in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. During the treatment phase, the background therapy will be switched to FP 500 mcg for 2 weeks and the dose of FP will be reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. The total duration of study will be approximately 33 weeks and approximately 165 subjects with moderately severe asthma who are maintained on high-dose of inhaled corticosteroids/ Long-Acting Beta-2-Agonists (ICS/LABA) will be randomized.
Interventions
DRUGGSK3772847
GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects.
DRUGPlacebo
Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects.
FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.
DRUGFluticasone propionate
FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double blind study and subjects and investigator will be masked.
Intervention model description
This will be a parallel intervention model in which GSK3772847 and placebo will be administered in parallel manner to randomized subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: At least 18 years of age at the time of signing the informed consent. * Males and females: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow highly effective contraceptive methods from 4 weeks prior to the first dose of study medication and until at least 16 weeks after the last dose of study medication and completion of the follow-up visit. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. * A subject with a documented diagnosis of moderate severe asthma based on Global Initiative for Asthma (GINA) 2016 Guidelines, whose asthma has been managed with regular treatment of high dose ICS defined as FP 500 mcg twice daily (i.e. 1000 mcg total daily dose) or equivalent, and LABA for at least 4 months. Additional therapy with a leukotriene receptor antagonist (LTRA) is permissible. * Airway reversibility of at least 12 percent and 200 milliliter (mL) in FEV1 at Screening (Visit 1), or documented reversibility prior to Screening (Visit 1), or documented history of bronchial hyper reactivity (e.g. fall in FEV1 from baseline of more than or equal to 20percent with standard doses of methacholine or histamine, or more than or equal to 15 percent with standardized hyperventilation, hypertonic saline or mannitol challenge) from a bronchoprovocation study \[e.g. methacholine challenge prior to Screening (Visit 1)\]. * ACQ-5 score more than or equal to 1.0 and less than 4.0 at Screening (Visit 1). * Had at least one asthma exacerbation within 12 months prior to screening that required treatment with systemic corticosteroid and/or hospitalization. * All subjects must be able to replace their current Short-Acting Beta2-Agonists (SABA) treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, per product label, for the duration of the study. Randomization inclusion criteria: * ACQ-5 score more than or equal to 1.0 and less than 4.0 at Visit 2. * Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on more than or equal to 4 of the last 7 days during the run-in period.
Exclusion criteria
* Current smokers or former smokers with a smoking history more than or equal to 10 pack years. * Presence of a known pre-existing, clinically important respiratory conditions (e.g. pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma. * A pre-bronchodilator FEV1 less than 50 percent predicted of normal value at Screening (Visit 1). * Subjects with a diagnosis of malignancy or in the process of investigation for a malignancy. Subjects with carcinoma that have not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment. * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at Screening (Visit 1) or within 3 months prior to first dose of study treatment. * Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of subject eligibility. * Weight: less than 50 kilograms (kg) and more than 150 kg. * Regular use of systemic corticosteroids for conditions including asthma within 3 months prior to Screening (Visit 1). * Subjects with high parasympathetic tone (e.g. trained athletes with baseline bradycardia) or chronic conditions associated with parasympathetic surges (e.g. migraines). * Other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1). * Clinically significant organic heart disease \[e.g. Coronary artery disease (CAD), New York Heart Association (NYHA) Class III/IV heart failure\]. * Ongoing infections (i.e. not resolved within 7 days prior to Screening \[Visit 1\]) or recurrent infections (i.e. requiring treatment for an identical diagnosis within 3 months) requiring systemic antibiotics Known, pre-existing parasitic infestations within 6 months prior to Screening. * A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. * A known immunodeficiency such as human immunodeficiency virus infection. * Subjects with allergy or intolerance to a monoclonal antibody or biologic or to any components of the formulation used in this study. * Subjects with a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Screening (Visit 1). * Subjects who are unable to follow study instructions such as visit schedule, dosing directions, study eDiary completion, or use of a standard metered dose inhaler. Subjects who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits. * Subjects who have previously participated in a study of GSK3772847. * Use of the prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study. Potential subjects should not be washed out of their medication solely for the purpose on enrolling in the trial. * A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub investigator, study coordinator, or employee of the participating investigator. * In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a diary card/questionnaire. * Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. Randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Loss of Asthma Control Over Weeks 0-16 | Up to Week 16 | Loss of asthma control is defined as: Asthma Control Questionnaire (ACQ-5) score increase from Baseline \>=0.5 point or pre-bronchodilator forced expiratory volume in 1 second (FEV1) decrease from baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral corticosteroid \[OCS\] and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 16 has been presented. Modified Intent-to-Treat (Loss of Control) (mITT\_LoC) population consisted of all randomized participants who took at least 1 dose of study treatment and if participants experienced loss of asthma control, they were analyzed according to actual treatment at time of loss of control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline | Baseline and up to Week 16 | The ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A change of \>=0.5 in score suggests a clinically important change in score. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment |
| Percentage of Participants Who Have Pre-bronchodilator FEV1 Decrease From Baseline >7.5 % | Baseline and up to Week 16 | Pulmonary function is measured by FEV1. FEV1 is the amount of air expired in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. Baseline is defined as the latest available pre-dose assessment (Day 1). Decrease from Baseline \>7.5 % in score suggests worsening of condition. |
| Percentage of Participants With Inability to Titrate Inhaled Corticosteroids (ICS) | Up to Week 16 | Corticosteroid titration allows overall clinical evaluation of the participant's asthma status taking into account both lung function and symptom control. Inability to titrate inhaled corticosteroids indicates loss of asthma control. |
| Percentage of Participants With Clinically Significant Asthma Exacerbation | Up to Week 16 | A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization. |
| Percentage of Participants With Loss of Asthma Control Over Weeks 0-6 | Up to Week 6 | Loss of asthma control is defined as: ACQ-5 score increase from Baseline \>=0.5 point or pre-bronchodilator FEV1 decrease from Baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral OCS and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 6 has been presented. |
| Time to Loss of Asthma Control | Up to Week 16 | Time to loss of asthma control was analyzed using Kaplan-Meier analysis. In this analysis, participants were either be counted as an event or they were censored. An event is defined as participants who experience loss of asthma control during the study. Censoring is defined as participants who discontinued investigational product for reasons other than loss of asthma control. The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Participants who didn't experience loss of asthma control were also censored at day 113. |
| Percentage of Participants With Clinically Significant Asthma Exacerbation or Inability to Titrate | Up to Week 16 | A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization. Participants with clinically significant asthma exacerbation or inability to titrate FP indicated loss of asthma control. |
| Number of Participants Experiencing Asthma Related Hospitalization During the Study Period | Up to Week 16 | Hospitalization is defined as an inpatient stay or least an overnight stay at the hospital or emergency ward for observation or other equivalent facility. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Rate Per 1000 Person-years of Participants With Hospitalization | Up to Week 16 | An event is defined as an on-treatment asthma-related hospitalization or emergency room visit and participants can contribute to more than one event. Rate is calculated as number of events \* 1000 divided by (number of participants in treatment group \* mean treatment exposure in years). Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16 | ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath & wheeze) enquire about the frequency &/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16 | ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath & wheeze) enquire about the frequency &/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A responder is defined as participants with change from Baseline of \<= -0.5 point at given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Baseline and Weeks 4, 8, 12 and 16 | SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on Health-related quality of life (HRQoL) of participants with Chronic Obstructive Pulmonary Disease (COPD). It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Baseline and Weeks 4, 8, 12 and 16 | SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). A responder is defined as a change from Baseline of \<= -4 at the given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Baseline and Weeks 2, 4, 6, 8, 10, 12, 14 and 16 | Pre-bronchodilator FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the latest available assessment prior to first dose (Day 1) and change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16. | PEF is maximum speed of expiration measured, using spirometer. The device was distributed to participants at Visit 1, to measure PEF twice-daily (morning upon waking & in the evening just before going to bed). Participants were encouraged to perform morning & evening PEF measurements before the use of any long-acting beta-agonists (LABAs) or rescue medication. Highest of 3 values were recorded in eDairy.Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mean PEF was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16).Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment |
| Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16 | Asthma symptoms experienced by participants during the day was recorded in e-Diary every evening before going to bed in form of scores on a 5-point rating scale. Scores ranged from 0=no daytime asthma symptoms to 4=very severe daytime asthma symptoms. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean asthma symptom score was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16 | The mean number of inhalation of rescue medication (albuterol/salbutamol) used to relieve symptoms immediately during the day and night was recorded in eDiary from Baseline until Week 16. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean rescue medication use was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16 | Participant captured night-time awakenings (yes/no) and use of rescue medication during these awakenings (yes/no) was recorded in e-Diary each morning. Percentage of night-time awakenings is calculated by number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data available\*100. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants having at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Night-time awakenings due to asthma symptoms requiring rescue medication was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14 and 16 | FeNO was assessed as a measure of airway inflammation using a handheld electronic device. The measurements recorded were according to standardized procedures by the American Thoracic Society and the European Respiratory Society Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide. FeNO measurements were obtained prior to FEV1 assessments. Participants did not use their rescue medication for at least 6 hours before each FeNO assessment, unless essential for clinical need. Baseline is defined as the latest available assessment prior to first dose (Day 1). Percent change from Baseline is calculated as ratio to Baseline minus one and multiplied by 100. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) | Up to Week 16 | A non-SAE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment were categorized as SAE. |
| Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28 | DBP and SBP were measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented. |
| Change From Baseline in Pulse Rate (PR) | Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28 | Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented. |
| Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | Baseline and Weeks 0, 4, 8 and 12 | DBP and SBP was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Baseline and Weeks 0, 4, 8 and 12 | Pulse rate was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16 | Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in ECG Heart Rate | Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16 | Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in QRS Axis | Baseline and Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16 | Triplicate 12-lead ECGs were recorded with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | Baseline and Weeks 0, 4, 8 and 12 | Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change Between Pre-dose and Post-dose of Heart Rate | Baseline and Weeks 0, 4, 8 and 12 | Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change Between Pre-dose and Post-dose of QRS Axis | Baseline and Weeks 0, 4, 8 and 12 | Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Baseline and Weeks 0, 4 and 12 | Using a Holter monitor, maximum, minimum and average changes in heart rate was recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | Baseline and Weeks 0, 4 and 12 | Using a Holter monitor, supraventricular couplets, supraventricular ectopics, supraventricular runs, supraventricular singles, ventricular couplets, ventricular ectopics, ventricular runs, ventricular singles were recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | Baseline and Weeks 2, 4, 8, 12, 16 and 28 | Blood samples were collected for the analysis of clinical chemistry parameters including AST, ALT, ALP, GGT and CK at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Baseline and Weeks 2, 4, 8, 12, 16 and 28 | Blood samples were collected at given time points to assess clinical chemistry parameters including glucose, potassium, sodium, calcium, Phosphate, chloride, urea and CO2 levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Baseline and Weeks 2, 4, 8, 12, 16 and 28 | Blood samples were collected for the analysis of clinical chemistry parameters including total bilirubin, creatinine and direct bilirubin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Baseline and Weeks 2, 4, 8, 12, 16 and 28 | Blood samples were collected at given time points to assess clinical chemistry parameters including total protein and albumin levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected at given time points to assess hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, leutrophils, monocytes, and platelets . Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of erythrocyte mean corpuscular volume at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameter: Erythrocytes | Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of erythrocytes at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameter: Hemoglobin | Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of hemoglobin level at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameter: Hematocrit Level | Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of hematocrit at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of mean corpuscular hemoglobin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of mean corpuscular hemoglobin concentration at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of Erythrocytes Distribution Width (%) at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Number of Hospitalizations or Emergency Room Visits Per Participants | Up to Week 16 | The number of hospitalization or emergency room visit made by per participant due to loss of asthma control have been presented in category titles. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. |
| Change From Baseline in Cardiac Marker: Cardiac Troponin I | Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of Troponin I at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and 28 | Blood samples were collected at given time points and the presence of anti-GSK3772847 antibodies were assessed using a a tiered approach including a screening assay, a confirmation assay and calculation of titer. Data for participants who showed positive results for confirmation assay has been presented |
| Serum Concentrations of GSK3772847 | Weeks 2, 4 (Pre-dose), 8 (Pre-dose), 12 (Pre-dose and Post-dose), 16, 20, 24 and 28 | Blood samples were collected at given time points to evaluate pharmacokinetics (PK) of GSK3772847 in participants with moderately severe asthma. |
| Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16 | Blood samples were collected at given time points to measure free soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100. |
| Percent Change From Baseline in Total Soluble ST2 Concentration | Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16 | Blood samples were collected at given time points to measure total soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100. |
| Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28 | Blood samples were collected for the analysis of N-Terminal ProB-type Natriuretic Peptide at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
Countries
Australia, Canada, Mexico, Russia, Ukraine, United States
Participant flow
Recruitment details
This was a randomized, double-blind, placebo-controlled, parallel-group multicenter study to assess the efficacy, safety and tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in participants with moderately severe asthma.
Pre-assignment details
A total of 165 participants with moderately severe asthma were randomized to receive GSK3772847 or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were administered placebo via intravenous (IV) route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the End of Treatment Period (ETP) Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief. | 82 |
| GSK3772847 Participants were administered 10 milligram/kilogram (mg/kg) GSK3772847 via IV route every 4 weeks (Weeks 0, 4, 8 and 12) in addition to open-label background therapy of FP/Sal 500/50 mcg twice daily. After 2 weeks, the background therapy was switched to FP 500 mcg for 2 weeks and the dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. Three Follow-up visits were performed after the ETP Visit (Weeks 20, 24, and 28) for safety assessments. Participants received salbutamol/albuterol to use as needed for asthma symptom relief. | 83 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Loss of Asthma Control | 47 | 31 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Specified Withdrawal Criteria | 7 | 2 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Placebo | GSK3772847 | Total |
|---|---|---|---|
| Age, Continuous | 54.1 Years STANDARD_DEVIATION 11.65 | 51.8 Years STANDARD_DEVIATION 11.74 | 52.9 Years STANDARD_DEVIATION 11.71 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 14 Participants | 8 Participants | 22 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 8 Participants | 11 Participants |
| Race/Ethnicity, Customized Central/South Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Japanese /East Asian/South East Asian Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 64 Participants | 66 Participants | 130 Participants |
| Sex: Female, Male Female | 54 Participants | 64 Participants | 118 Participants |
| Sex: Female, Male Male | 28 Participants | 19 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 83 |
| other Total, other adverse events | 20 / 82 | 19 / 83 |
| serious Total, serious adverse events | 1 / 82 | 2 / 83 |
Outcome results
Primary
Percentage of Participants With Loss of Asthma Control Over Weeks 0-16
Loss of asthma control is defined as: Asthma Control Questionnaire (ACQ-5) score increase from Baseline \>=0.5 point or pre-bronchodilator forced expiratory volume in 1 second (FEV1) decrease from baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral corticosteroid \[OCS\] and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 16 has been presented. Modified Intent-to-Treat (Loss of Control) (mITT\_LoC) population consisted of all randomized participants who took at least 1 dose of study treatment and if participants experienced loss of asthma control, they were analyzed according to actual treatment at time of loss of control.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat (Loss of Control) (mITT\_LoC) Population. Only those participants with data available at indicated time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Loss of Asthma Control Over Weeks 0-16 | 81 Percentage of participants |
| GSK3772847 | Percentage of Participants With Loss of Asthma Control Over Weeks 0-16 | 67 Percentage of participants |
95% CI: [0.66, 0.99]
Secondary
Change Between Pre-dose and Post-dose of Heart Rate
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 0, 4, 8 and 12
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change Between Pre-dose and Post-dose of Heart Rate | Week0; n=80, 80 | -1.6 Beats per minute | Standard Deviation 7.57 |
| Placebo | Change Between Pre-dose and Post-dose of Heart Rate | Week4; n=48, 59 | -2.9 Beats per minute | Standard Deviation 5.79 |
| Placebo | Change Between Pre-dose and Post-dose of Heart Rate | Week8; n=33, 47 | -1.8 Beats per minute | Standard Deviation 8.74 |
| Placebo | Change Between Pre-dose and Post-dose of Heart Rate | Week12; n=24, 39 | -0.2 Beats per minute | Standard Deviation 6.69 |
| GSK3772847 | Change Between Pre-dose and Post-dose of Heart Rate | Week12; n=24, 39 | -0.9 Beats per minute | Standard Deviation 7.75 |
| GSK3772847 | Change Between Pre-dose and Post-dose of Heart Rate | Week0; n=80, 80 | 0.2 Beats per minute | Standard Deviation 6.93 |
| GSK3772847 | Change Between Pre-dose and Post-dose of Heart Rate | Week8; n=33, 47 | -2.3 Beats per minute | Standard Deviation 6.83 |
| GSK3772847 | Change Between Pre-dose and Post-dose of Heart Rate | Week4; n=48, 59 | -1.7 Beats per minute | Standard Deviation 6.15 |
Secondary
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 0, 4, 8 and 12
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR:Week0; n=80, 80 | 1.8 milliseconds | Standard Deviation 9.77 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR: Week4; n=48, 59 | 1.7 milliseconds | Standard Deviation 8.04 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR: Week8; n=33, 47 | 0.3 milliseconds | Standard Deviation 8.7 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR: Week12; n=24, 39 | 2.2 milliseconds | Standard Deviation 10 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS:Week0; n=80, 80 | 0.0 milliseconds | Standard Deviation 5.75 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS: Week4; n=48, 59 | 0.1 milliseconds | Standard Deviation 4.35 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS:Week8; n=33, 47 | 0.3 milliseconds | Standard Deviation 7.03 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS:Week12; n=24, 39 | 0.7 milliseconds | Standard Deviation 5.36 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week0; n=80, 80 | 7.4 milliseconds | Standard Deviation 19.67 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week4; n=48, 59 | 10.8 milliseconds | Standard Deviation 13.32 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week8; n=33, 47 | 3.4 milliseconds | Standard Deviation 19.22 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week12; n=24, 39 | 1.9 milliseconds | Standard Deviation 17.17 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcFWeek0; n=80, 80 | 4.2 milliseconds | Standard Deviation 12.56 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcF:Week4; n=48, 59 | 5.4 milliseconds | Standard Deviation 9.51 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcF:Week8; n=33, 47 | -0.7 milliseconds | Standard Deviation 10.17 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcF:Week12; n=24, 39 | 1.1 milliseconds | Standard Deviation 13.28 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week0; n=80, 80 | 24.0 milliseconds | Standard Deviation 104.42 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week4; n=48, 59 | 37.6 milliseconds | Standard Deviation 83.83 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week8; n=33, 47 | 29.3 milliseconds | Standard Deviation 97.67 |
| Placebo | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week12; n=24, 39 | 8.8 milliseconds | Standard Deviation 83.16 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week4; n=48, 59 | 29.5 milliseconds | Standard Deviation 88.38 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR:Week0; n=80, 80 | 3.1 milliseconds | Standard Deviation 9.28 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week8; n=33, 47 | 11.5 milliseconds | Standard Deviation 17.57 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR: Week4; n=48, 59 | 0.5 milliseconds | Standard Deviation 9.77 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcF:Week12; n=24, 39 | 2.0 milliseconds | Standard Deviation 13.48 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR: Week8; n=33, 47 | -0.1 milliseconds | Standard Deviation 9.96 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week12; n=24, 39 | 4.6 milliseconds | Standard Deviation 18.77 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | PR: Week12; n=24, 39 | 3.0 milliseconds | Standard Deviation 9.86 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week12; n=24, 39 | 20.7 milliseconds | Standard Deviation 104.02 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS:Week0; n=80, 80 | 0.2 milliseconds | Standard Deviation 5.6 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcFWeek0; n=80, 80 | 3.8 milliseconds | Standard Deviation 11.21 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS: Week4; n=48, 59 | -0.8 milliseconds | Standard Deviation 5.58 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week0; n=80, 80 | -0.2 milliseconds | Standard Deviation 89.38 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS:Week8; n=33, 47 | 0.4 milliseconds | Standard Deviation 4.86 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcF:Week4; n=48, 59 | 2.9 milliseconds | Standard Deviation 10.88 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QRS:Week12; n=24, 39 | -0.9 milliseconds | Standard Deviation 4.6 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | RR:Week8; n=33, 47 | 34.4 milliseconds | Standard Deviation 95.05 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week0; n=80, 80 | 3.5 milliseconds | Standard Deviation 16.69 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QTcF:Week8; n=33, 47 | 6.6 milliseconds | Standard Deviation 10.65 |
| GSK3772847 | Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval | QT:Week4; n=48, 59 | 6.9 milliseconds | Standard Deviation 15.63 |
Secondary
Change Between Pre-dose and Post-dose of QRS Axis
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 0, 4, 8 and 12
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change Between Pre-dose and Post-dose of QRS Axis | Week0; n=80, 80 | -0.8 Degrees | Standard Deviation 10.76 |
| Placebo | Change Between Pre-dose and Post-dose of QRS Axis | Week4; n=48, 59 | -0.3 Degrees | Standard Deviation 9.2 |
| Placebo | Change Between Pre-dose and Post-dose of QRS Axis | Week8; n=33, 47 | 1.2 Degrees | Standard Deviation 10.01 |
| Placebo | Change Between Pre-dose and Post-dose of QRS Axis | Week12; n=24, 39 | -1.6 Degrees | Standard Deviation 6.44 |
| GSK3772847 | Change Between Pre-dose and Post-dose of QRS Axis | Week12; n=24, 39 | 2.8 Degrees | Standard Deviation 14.25 |
| GSK3772847 | Change Between Pre-dose and Post-dose of QRS Axis | Week0; n=80, 80 | 1.9 Degrees | Standard Deviation 6.75 |
| GSK3772847 | Change Between Pre-dose and Post-dose of QRS Axis | Week8; n=33, 47 | -0.2 Degrees | Standard Deviation 9.3 |
| GSK3772847 | Change Between Pre-dose and Post-dose of QRS Axis | Week4; n=48, 59 | -0.9 Degrees | Standard Deviation 16.22 |
Secondary
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
DBP and SBP was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 0, 4, 8 and 12
Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week0; n=82, 83 | -2.0 mmHg | Standard Deviation 8.05 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week4; n=48, 59 | -0.4 mmHg | Standard Deviation 5.7 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week8; n=34, 47 | -0.8 mmHg | Standard Deviation 6.03 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week12; n=24, 39 | -0.9 mmHg | Standard Deviation 7.51 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week0; n=82, 83 | -0.7 mmHg | Standard Deviation 6.58 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week4; n=48, 59 | 0.4 mmHg | Standard Deviation 4.95 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week8; n=34, 47 | 0.2 mmHg | Standard Deviation 4.38 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week12; n=24, 39 | -0.3 mmHg | Standard Deviation 4.7 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week12; n=24, 39 | -1.1 mmHg | Standard Deviation 6.08 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week0; n=82, 83 | 1.3 mmHg | Standard Deviation 7.19 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week0; n=82, 83 | -0.3 mmHg | Standard Deviation 5.67 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week4; n=48, 59 | 2.4 mmHg | Standard Deviation 9.32 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week8; n=34, 47 | 0.8 mmHg | Standard Deviation 5.55 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week8; n=34, 47 | 1.9 mmHg | Standard Deviation 6.58 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | DBP: Week4; n=48, 59 | -0.1 mmHg | Standard Deviation 6.76 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in DBP and SBP | SBP: Week12; n=24, 39 | 1.8 mmHg | Standard Deviation 8.72 |
Secondary
Change From Baseline Between Post-dose and Pre-dose in Pulse Rate
Pulse rate was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 0, 4, 8 and 12
Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week0; n=82, 83 | -2.2 Beats per minute | Standard Deviation 7.2 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week4; n=48, 59 | -1.6 Beats per minute | Standard Deviation 5.75 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week8; n=34, 47 | -0.5 Beats per minute | Standard Deviation 7.21 |
| Placebo | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week12; n=24, 39 | -2.0 Beats per minute | Standard Deviation 5.97 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week12; n=24, 39 | -2.9 Beats per minute | Standard Deviation 9.05 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week0; n=82, 83 | -0.1 Beats per minute | Standard Deviation 6.54 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week8; n=34, 47 | -1.6 Beats per minute | Standard Deviation 6.02 |
| GSK3772847 | Change From Baseline Between Post-dose and Pre-dose in Pulse Rate | Week4; n=48, 59 | -1.1 Beats per minute | Standard Deviation 6.85 |
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath & wheeze) enquire about the frequency &/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week1; n=72, 73 | -0.36 Scores on a scale | Standard Deviation 0.713 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week9; n=30, 42 | -0.93 Scores on a scale | Standard Deviation 0.713 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week5; n= 42, 52 | -0.80 Scores on a scale | Standard Deviation 0.839 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week10; n=29, 41 | -0.97 Scores on a scale | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week3; n=61, 61 | -0.59 Scores on a scale | Standard Deviation 0.722 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week11; n=22, 38 | -1.05 Scores on a scale | Standard Deviation 0.907 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week12; n=23, 38 | -0.88 Scores on a scale | Standard Deviation 1.134 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week6; n=40, 48 | -0.80 Scores on a scale | Standard Deviation 0.907 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week13; n=17,32 | -1.40 Scores on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week2; n=67, 68 | -0.53 Scores on a scale | Standard Deviation 0.666 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week14; n=17, 31 | -1.33 Scores on a scale | Standard Deviation 0.943 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week7; n=34, 46 | -0.92 Scores on a scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week15; n=17, 27 | -1.22 Scores on a scale | Standard Deviation 0.874 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week4; n=54, 59 | -0.69 Scores on a scale | Standard Deviation 0.733 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week16; n=12, 21 | -1.15 Scores on a scale | Standard Deviation 1.102 |
| Placebo | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week8; n=33, 44 | -0.95 Scores on a scale | Standard Deviation 0.769 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week16; n=12, 21 | -1.17 Scores on a scale | Standard Deviation 0.738 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week1; n=72, 73 | -0.48 Scores on a scale | Standard Deviation 0.685 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week2; n=67, 68 | -0.74 Scores on a scale | Standard Deviation 0.732 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week3; n=61, 61 | -0.78 Scores on a scale | Standard Deviation 0.663 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week4; n=54, 59 | -0.79 Scores on a scale | Standard Deviation 0.695 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week5; n= 42, 52 | -0.78 Scores on a scale | Standard Deviation 0.804 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week6; n=40, 48 | -0.93 Scores on a scale | Standard Deviation 0.692 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week7; n=34, 46 | -0.93 Scores on a scale | Standard Deviation 0.785 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week8; n=33, 44 | -1.00 Scores on a scale | Standard Deviation 0.755 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week9; n=30, 42 | -0.97 Scores on a scale | Standard Deviation 0.817 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week10; n=29, 41 | -0.99 Scores on a scale | Standard Deviation 0.729 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week12; n=23, 38 | -1.16 Scores on a scale | Standard Deviation 0.795 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week13; n=17,32 | -1.06 Scores on a scale | Standard Deviation 0.773 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week14; n=17, 31 | -1.14 Scores on a scale | Standard Deviation 0.82 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week15; n=17, 27 | -1.21 Scores on a scale | Standard Deviation 0.814 |
| GSK3772847 | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score | Week11; n=22, 38 | -1.07 Scores on a scale | Standard Deviation 0.77 |
Secondary
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Blood samples were collected for the analysis of Troponin I at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 1: n=78,74 | 0.000 Micrograms per liter | Standard Deviation 0 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 2: n=73, 73 | 0.000 Micrograms per liter | Standard Deviation 0.0016 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 4: n=49, 58 | 0.001 Micrograms per liter | Standard Deviation 0.0059 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 6: n=45, 57 | 0.000 Micrograms per liter | Standard Deviation 0.0021 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 8: n=34, 46 | 0.000 Micrograms per liter | Standard Deviation 0.0017 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 10: n=34, 38 | 0.006 Micrograms per liter | Standard Deviation 0.0344 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 12: n=24, 39 | 0.000 Micrograms per liter | Standard Deviation 0 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 14: n=24, 39 | 0.000 Micrograms per liter | Standard Deviation 0 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 16: n=24, 39 | 0.000 Micrograms per liter | Standard Deviation 0 |
| Placebo | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 28: n=63, 63 | 0.000 Micrograms per liter | Standard Deviation 0.0013 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 14: n=24, 39 | 0.000 Micrograms per liter | Standard Deviation 0.0016 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 1: n=78,74 | 0.000 Micrograms per liter | Standard Deviation 0.0023 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 10: n=34, 38 | 0.000 Micrograms per liter | Standard Deviation 0 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 2: n=73, 73 | 0.000 Micrograms per liter | Standard Deviation 0.0023 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 28: n=63, 63 | -0.001 Micrograms per liter | Standard Deviation 0.005 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 4: n=49, 58 | 0.000 Micrograms per liter | Standard Deviation 0 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 12: n=24, 39 | 0.000 Micrograms per liter | Standard Deviation 0 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 6: n=45, 57 | 0.000 Micrograms per liter | Standard Deviation 0 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 16: n=24, 39 | 0.000 Micrograms per liter | Standard Deviation 0 |
| GSK3772847 | Change From Baseline in Cardiac Marker: Cardiac Troponin I | Week 8: n=34, 46 | 0.000 Micrograms per liter | Standard Deviation 0 |
Secondary
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Blood samples were collected for the analysis of N-Terminal ProB-type Natriuretic Peptide at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 1: n=79,75 | -14.8442 Nanograms per liter | Standard Deviation 61.92992 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 2: n=73,75 | -10.8134 Nanograms per liter | Standard Deviation 71.40009 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 4: n=49, 59 | -17.9849 Nanograms per liter | Standard Deviation 68.85651 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 6: n=45, 57 | -5.0620 Nanograms per liter | Standard Deviation 53.06025 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 8: n=34, 47 | -8.6398 Nanograms per liter | Standard Deviation 49.58134 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 10: n=34, 46 | -12.7377 Nanograms per liter | Standard Deviation 80.51666 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 12: n=24, 38 | -13.6951 Nanograms per liter | Standard Deviation 53.70314 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 14: n=24, 39 | -4.8082 Nanograms per liter | Standard Deviation 57.47926 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 16: n=24, 39 | -19.4899 Nanograms per liter | Standard Deviation 58.89689 |
| Placebo | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 28: n=65, 65 | -6.1970 Nanograms per liter | Standard Deviation 62.26132 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 14: n=24, 39 | 20.0149 Nanograms per liter | Standard Deviation 74.94234 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 1: n=79,75 | 8.4023 Nanograms per liter | Standard Deviation 54.37938 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 10: n=34, 46 | 14.9119 Nanograms per liter | Standard Deviation 58.17102 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 2: n=73,75 | -2.5196 Nanograms per liter | Standard Deviation 42.06499 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 28: n=65, 65 | 0.9810 Nanograms per liter | Standard Deviation 64.44446 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 4: n=49, 59 | -4.5560 Nanograms per liter | Standard Deviation 44.12297 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 12: n=24, 38 | 8.8531 Nanograms per liter | Standard Deviation 58.15689 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 6: n=45, 57 | 3.6194 Nanograms per liter | Standard Deviation 53.96329 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 16: n=24, 39 | 4.7760 Nanograms per liter | Standard Deviation 60.56438 |
| GSK3772847 | Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide | Week 8: n=34, 47 | 9.6509 Nanograms per liter | Standard Deviation 66.34546 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
Blood samples were collected for the analysis of clinical chemistry parameters including AST, ALT, ALP, GGT and CK at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 12, n=24, 36 | -1.8 International units per liter | Standard Deviation 4.91 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 8; n=34, 47 | 0.9 International units per liter | Standard Deviation 7.37 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 16, n=24, 39 | -1.4 International units per liter | Standard Deviation 6.01 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT:Week 4; n=47,59 | -0.5 International units per liter | Standard Deviation 9.5 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 28, n=74, 74 | -2.3 International units per liter | Standard Deviation 6.96 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 12; n =24, 36 | 2.4 International units per liter | Standard Deviation 8.79 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK: Week 2, n=72, 74 | -12.5 International units per liter | Standard Deviation 92 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 28; n=74, 74 | -1.1 International units per liter | Standard Deviation 9.57 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 4, n=47,59 | -30.3 International units per liter | Standard Deviation 68.86 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 16; n=24, 39 | 1.0 International units per liter | Standard Deviation 9.33 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 8, n=34,47 | -26.6 International units per liter | Standard Deviation 57.01 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 12; n=24, 36 | -1.6 International units per liter | Standard Deviation 6.86 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 12, n=24, 36 | -5.0 International units per liter | Standard Deviation 73.56 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 28; n=74, 74 | -0.4 International units per liter | Standard Deviation 12.33 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 16, n=24, 39 | -20.8 International units per liter | Standard Deviation 81.02 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP: Week 2; n=72, 74 | -1.9 International units per liter | Standard Deviation 8.32 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 28, n=74, 74 | -8.5 International units per liter | Standard Deviation 131.56 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST: Week 2; n=72, 74 | -0.8 International units per liter | Standard Deviation 9.3 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT: Week 2, n=72, 74 | -3.2 International units per liter | Standard Deviation 9.61 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 8; n=34,47 | -0.1 International units per liter | Standard Deviation 6.93 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 4, n=47,59 | -3.9 International units per liter | Standard Deviation 14 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 4; n=47,59 | -1.0 International units per liter | Standard Deviation 6.02 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 8, n=34,47 | -3.5 International units per liter | Standard Deviation 13.5 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 4; n=47, 59 | -0.8 International units per liter | Standard Deviation 13.18 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 12, 24, 36 | -0.3 International units per liter | Standard Deviation 5.87 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 8, n=34,47 | -1.6 International units per liter | Standard Deviation 6.58 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 16, n=24, 39 | -1.1 International units per liter | Standard Deviation 4.41 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 16; n=24, 39 | -1.2 International units per liter | Standard Deviation 7.97 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 28, n=74, 73 | -3.2 International units per liter | Standard Deviation 13.8 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 2; n=72, 74 | -0.9 International units per liter | Standard Deviation 8.88 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 28, n=74, 73 | -0.7 International units per liter | Standard Deviation 16.06 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 2; n=72, 74 | -0.2 International units per liter | Standard Deviation 7.07 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT:Week 4; n=47,59 | -2.6 International units per liter | Standard Deviation 7.24 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 8; n=34,47 | -2.4 International units per liter | Standard Deviation 7.3 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 12; n=24, 36 | -2.4 International units per liter | Standard Deviation 7.77 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 16; n=24, 39 | -2.6 International units per liter | Standard Deviation 6.54 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALT: Week 28; n=74, 74 | -0.9 International units per liter | Standard Deviation 10.51 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP: Week 2; n=72, 74 | -0.8 International units per liter | Standard Deviation 8.96 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 4; n=47, 59 | -1.0 International units per liter | Standard Deviation 8.17 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 8; n=34, 47 | -2.3 International units per liter | Standard Deviation 8.64 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 12; n =24, 36 | -3.0 International units per liter | Standard Deviation 14.01 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 16; n=24, 39 | -2.3 International units per liter | Standard Deviation 9.75 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | ALP:Week 28; n=74, 74 | -1.2 International units per liter | Standard Deviation 13.25 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST: Week 2; n=72, 74 | -1.5 International units per liter | Standard Deviation 6.59 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 4; n=47,59 | -2.5 International units per liter | Standard Deviation 6.75 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 8, n=34,47 | -2.7 International units per liter | Standard Deviation 6.36 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 12, n=24, 36 | -4.1 International units per liter | Standard Deviation 6.59 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 16, n=24, 39 | -3.3 International units per liter | Standard Deviation 6.7 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | AST:Week 28, n=74, 74 | -1.7 International units per liter | Standard Deviation 8.64 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK: Week 2, n=72, 74 | -18.8 International units per liter | Standard Deviation 207.72 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 4, n=47,59 | -45.1 International units per liter | Standard Deviation 231.07 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 8, n=34,47 | -32.9 International units per liter | Standard Deviation 242.98 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 12, n=24, 36 | -54.5 International units per liter | Standard Deviation 282.17 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 16, n=24, 39 | -46.8 International units per liter | Standard Deviation 272.08 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | CK:Week 28, n=74, 74 | -30.7 International units per liter | Standard Deviation 199.41 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT: Week 2, n=72, 74 | -1.2 International units per liter | Standard Deviation 12.16 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 4, n=47,59 | -2.5 International units per liter | Standard Deviation 21.35 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 8, n=34,47 | -2.8 International units per liter | Standard Deviation 15.61 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 12, 24, 36 | -5.4 International units per liter | Standard Deviation 19.48 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK) | GGT:Week 16, n=24, 39 | -3.9 International units per liter | Standard Deviation 14.64 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including total bilirubin, creatinine and direct bilirubin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine: Week 2; n=72, 74 | 2.35 Micromoles per liter | Standard Deviation 6.911 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 4; n=47, 59 | 2.35 Micromoles per liter | Standard Deviation 8.319 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 8; n=34, 47 | 1.18 Micromoles per liter | Standard Deviation 7.677 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 12; n=24, 36 | 2.42 Micromoles per liter | Standard Deviation 6.521 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 16; n=24, 39 | 2.50 Micromoles per liter | Standard Deviation 8.685 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 28; n=74, 73 | 4.32 Micromoles per liter | Standard Deviation 6.81 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin : Week 2; n=72, 74 | -0.1 Micromoles per liter | Standard Deviation 3.22 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 4; n=47, 59 | -0.3 Micromoles per liter | Standard Deviation 3.24 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 8; n=34, 47 | -0.1 Micromoles per liter | Standard Deviation 2.46 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 12; n=24, 36 | -0.6 Micromoles per liter | Standard Deviation 2.32 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 16; n=24, 39 | 0.0 Micromoles per liter | Standard Deviation 2.83 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 28; n=74, 74 | 0.1 Micromoles per liter | Standard Deviation 2.77 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin : Week 2; n=72, 74 | -0.1 Micromoles per liter | Standard Deviation 1.18 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 4; n=47,59 | -0.1 Micromoles per liter | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 8; n=34, 47 | -0.1 Micromoles per liter | Standard Deviation 1.04 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 12; n=24, 36 | -0.4 Micromoles per liter | Standard Deviation 1.18 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 16; n=24, 39 | 0.1 Micromoles per liter | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 28; n=74, 74 | 0.1 Micromoles per liter | Standard Deviation 1.17 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 4; n=47,59 | 0.1 Micromoles per liter | Standard Deviation 1.11 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine: Week 2; n=72, 74 | 1.71 Micromoles per liter | Standard Deviation 8.321 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 12; n=24, 36 | 0.1 Micromoles per liter | Standard Deviation 4.56 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 4; n=47, 59 | 0.72 Micromoles per liter | Standard Deviation 6.61 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 28; n=74, 74 | 0.1 Micromoles per liter | Standard Deviation 1.13 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 8; n=34, 47 | 1.76 Micromoles per liter | Standard Deviation 6.072 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 16; n=24, 39 | -0.3 Micromoles per liter | Standard Deviation 3.39 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 12; n=24, 36 | 0.02 Micromoles per liter | Standard Deviation 5.866 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 8; n=34, 47 | 0.2 Micromoles per liter | Standard Deviation 1.17 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 16; n=24, 39 | 0.91 Micromoles per liter | Standard Deviation 6.105 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 28; n=74, 74 | -0.5 Micromoles per liter | Standard Deviation 3.94 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine:Week 28; n=74, 73 | 2.9 Micromoles per liter | Standard Deviation 6.356 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 16; n=24, 39 | 0.1 Micromoles per liter | Standard Deviation 1.07 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin : Week 2; n=72, 74 | 0.1 Micromoles per liter | Standard Deviation 2.83 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin : Week 2; n=72, 74 | 0.0 Micromoles per liter | Standard Deviation 1.02 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 4; n=47, 59 | -0.4 Micromoles per liter | Standard Deviation 2.98 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin :Week 12; n=24, 36 | 0.2 Micromoles per liter | Standard Deviation 1.11 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin | Total Bilirubin :Week 8; n=34, 47 | -0.2 Micromoles per liter | Standard Deviation 4.04 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Blood samples were collected at given time points to assess clinical chemistry parameters including glucose, potassium, sodium, calcium, Phosphate, chloride, urea and CO2 levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium: Week 2; n=72, 74 | 0.3 Millimoles per liter | Standard Deviation 2.19 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 4; n=47,59 | 0.18 Millimoles per liter | Standard Deviation 0.784 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 8; n=34,47 | 0.26 Millimoles per liter | Standard Deviation 1.008 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 12; n=24, 36 | -0.04 Millimoles per liter | Standard Deviation 0.796 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 16; n=24, 39 | -0.10 Millimoles per liter | Standard Deviation 1.057 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 28; n=74, 73 | 0.30 Millimoles per liter | Standard Deviation 1.245 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium: Week 2; n=72, 74 | 0.14 Millimoles per liter | Standard Deviation 0.366 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 4; n=47,59 | 0.04 Millimoles per liter | Standard Deviation 0.361 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 8; n=34,47 | -0.01 Millimoles per liter | Standard Deviation 0.352 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 12; n=24, 36 | 0.02 Millimoles per liter | Standard Deviation 0.363 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 16; n=24, 39 | -0.09 Millimoles per liter | Standard Deviation 0.403 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 28; n=74, 73 | 0.01 Millimoles per liter | Standard Deviation 0.407 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose: Week 2; n=72, 74 | 0.13 Millimoles per liter | Standard Deviation 0.996 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 4; n=47,59 | 0.0 Millimoles per liter | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 8; n=34,47 | -0.1 Millimoles per liter | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 12; n=24, 36 | -0.3 Millimoles per liter | Standard Deviation 2.17 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 16; n=24, 39 | -0.2 Millimoles per liter | Standard Deviation 2.14 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 28; n=74, 73 | 0.5 Millimoles per liter | Standard Deviation 2.55 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium: Week 2; n=72, 74 | -0.006 Millimoles per liter | Standard Deviation 0.0691 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 4; n=47,59 | -0.013 Millimoles per liter | Standard Deviation 0.0873 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 8; n=34,47 | -0.005 Millimoles per liter | Standard Deviation 0.0648 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 12; n=24, 36 | 0.018 Millimoles per liter | Standard Deviation 0.0962 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 16; n=24, 39 | 0.014 Millimoles per liter | Standard Deviation 0.095 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 28; n=74, 73 | 0.001 Millimoles per liter | Standard Deviation 0.0776 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate: Week 2; n=72, 74 | 0.031 Millimoles per liter | Standard Deviation 0.1467 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 4; n=47,59 | 0.003 Millimoles per liter | Standard Deviation 0.1312 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 8; n=34,47 | 0.006 Millimoles per liter | Standard Deviation 0.1678 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 12; n=24, 36 | 0.025 Millimoles per liter | Standard Deviation 0.1133 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 16; n=24, 39 | -0.006 Millimoles per liter | Standard Deviation 0.137 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 28; n=74, 73 | -0.013 Millimoles per liter | Standard Deviation 0.1854 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride: Week 2; n=72, 74 | 0.3 Millimoles per liter | Standard Deviation 2.47 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 4; n=47,59 | 0.0 Millimoles per liter | Standard Deviation 2.04 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 8; n=34,47 | -0.2 Millimoles per liter | Standard Deviation 1.97 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 12; n=24, 36 | -0.1 Millimoles per liter | Standard Deviation 2.61 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 16; n=24, 39 | -0.4 Millimoles per liter | Standard Deviation 2.95 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 28; n=74, 73 | 0.6 Millimoles per liter | Standard Deviation 2.65 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2: Week 2; n=72, 74 | -0.4 Millimoles per liter | Standard Deviation 2.71 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 4; n=47,59 | -0.4 Millimoles per liter | Standard Deviation 2.26 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 8; n=34,46 | -0.3 Millimoles per liter | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 12; n=24, 36 | -0.5 Millimoles per liter | Standard Deviation 2.6 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 16; n=24, 39 | -0.5 Millimoles per liter | Standard Deviation 2.34 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 28; n=74, 73 | -0.1 Millimoles per liter | Standard Deviation 2.28 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea: Week 2; n=72, 74 | 0.08 Millimoles per liter | Standard Deviation 1.311 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 4; n=47,59 | 0.16 Millimoles per liter | Standard Deviation 1.344 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 8; n=34,47 | -0.04 Millimoles per liter | Standard Deviation 1.264 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 12; n=24, 36 | 0.58 Millimoles per liter | Standard Deviation 1.537 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 16; n=24, 39 | 0.48 Millimoles per liter | Standard Deviation 1.379 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 28; n=74, 73 | 0.08 Millimoles per liter | Standard Deviation 1.089 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 16; n=24, 39 | 0.03 Millimoles per liter | Standard Deviation 1.287 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose: Week 2; n=72, 74 | 0.05 Millimoles per liter | Standard Deviation 1.273 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate: Week 2; n=72, 74 | -0.023 Millimoles per liter | Standard Deviation 0.1502 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 4; n=47,59 | 0.19 Millimoles per liter | Standard Deviation 1.156 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2: Week 2; n=72, 74 | 0.4 Millimoles per liter | Standard Deviation 2.1 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 8; n=34,47 | 0.00 Millimoles per liter | Standard Deviation 1.4 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 4; n=47,59 | -0.011 Millimoles per liter | Standard Deviation 0.1362 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 12; n=24, 36 | 0.20 Millimoles per liter | Standard Deviation 1.516 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea: Week 2; n=72, 74 | -0.14 Millimoles per liter | Standard Deviation 1.108 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 16; n=24, 39 | 0.12 Millimoles per liter | Standard Deviation 0.984 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 8; n=34,47 | -0.049 Millimoles per liter | Standard Deviation 0.142 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Glucose:Week 28; n=74, 73 | 0.04 Millimoles per liter | Standard Deviation 1.78 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 4; n=47,59 | 0.3 Millimoles per liter | Standard Deviation 2.82 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium: Week 2; n=72, 74 | 0.13 Millimoles per liter | Standard Deviation 0.596 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 12; n=24, 36 | -0.013 Millimoles per liter | Standard Deviation 0.1495 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 4; n=47,59 | 0.05 Millimoles per liter | Standard Deviation 0.402 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 12; n=24, 36 | -0.06 Millimoles per liter | Standard Deviation 1.346 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 8; n=34,47 | -0.04 Millimoles per liter | Standard Deviation 0.397 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 16; n=24, 39 | -0.019 Millimoles per liter | Standard Deviation 0.1503 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 12; n=24, 36 | 0.00 Millimoles per liter | Standard Deviation 0.439 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 8; n=34,46 | -0.3 Millimoles per liter | Standard Deviation 1.84 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 16; n=24, 39 | 0.00 Millimoles per liter | Standard Deviation 0.439 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Phosphate:Week 28; n=74, 73 | -0.018 Millimoles per liter | Standard Deviation 0.1743 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Potassium:Week 28; n=74, 73 | 0.01 Millimoles per liter | Standard Deviation 0.416 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 4; n=47,59 | -0.14 Millimoles per liter | Standard Deviation 1.102 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium: Week 2; n=72, 74 | -0.1 Millimoles per liter | Standard Deviation 2.31 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride: Week 2; n=72, 74 | 0.1 Millimoles per liter | Standard Deviation 2.22 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 4; n=47,59 | -0.9 Millimoles per liter | Standard Deviation 2.34 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 12; n=24, 36 | -0.1 Millimoles per liter | Standard Deviation 2.1 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 8; n=34,47 | -0.6 Millimoles per liter | Standard Deviation 1.51 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 4; n=47,59 | -0.3 Millimoles per liter | Standard Deviation 2.18 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 12; n=24, 36 | -1.1 Millimoles per liter | Standard Deviation 1.71 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 28; n=74, 73 | 0.16 Millimoles per liter | Standard Deviation 1.121 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 16; n=24, 39 | -0.3 Millimoles per liter | Standard Deviation 2.01 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 8; n=34,47 | 0.0 Millimoles per liter | Standard Deviation 2.03 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Sodium:Week 28; n=74, 73 | -0.2 Millimoles per liter | Standard Deviation 2.11 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 16; n=24, 39 | 0.1 Millimoles per liter | Standard Deviation 2.28 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium: Week 2; n=72, 74 | 0.001 Millimoles per liter | Standard Deviation 0.0925 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 12; n=24, 36 | -0.3 Millimoles per liter | Standard Deviation 2.13 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 4; n=47,59 | -0.005 Millimoles per liter | Standard Deviation 0.0743 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Urea:Week 8; n=34,47 | 0.27 Millimoles per liter | Standard Deviation 1.151 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 8; n=34,47 | -0.003 Millimoles per liter | Standard Deviation 0.0997 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 16; n=24, 39 | -0.2 Millimoles per liter | Standard Deviation 2.61 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 12; n=24, 36 | -0.004 Millimoles per liter | Standard Deviation 0.0949 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | CO2:Week 28; n=74, 73 | 0.3 Millimoles per liter | Standard Deviation 2.15 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 16; n=24, 39 | 0.017 Millimoles per liter | Standard Deviation 0.0963 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Chloride:Week 28; n=74, 73 | 0.7 Millimoles per liter | Standard Deviation 2.24 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2) | Calcium:Week 28; n=74, 73 | 0.001 Millimoles per liter | Standard Deviation 0.0994 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Blood samples were collected at given time points to assess clinical chemistry parameters including total protein and albumin levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein: Week 2, n=72, 74 | -0.5 Grams per liter | Standard Deviation 3.49 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 4, n=47,59 | -0.4 Grams per liter | Standard Deviation 3.44 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 8, n=34,47 | 0.1 Grams per liter | Standard Deviation 3.2 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 12, n=24, 36 | 0.2 Grams per liter | Standard Deviation 4.05 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 16, n=24, 39 | 0.5 Grams per liter | Standard Deviation 4.33 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 28, n=74, 73 | -0.8 Grams per liter | Standard Deviation 4.04 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin: Week 2, n=72, 74 | -0.5 Grams per liter | Standard Deviation 2.38 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 4, n=47,59 | -0.5 Grams per liter | Standard Deviation 2.29 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 8, n=34,47 | -0.4 Grams per liter | Standard Deviation 2.36 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 12, n=24, 36 | -0.3 Grams per liter | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 16, n=24, 39 | -0.1 Grams per liter | Standard Deviation 2.82 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 28, n=74, 73 | -0.6 Grams per liter | Standard Deviation 2.7 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 16, n=24, 39 | -0.4 Grams per liter | Standard Deviation 2.25 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein: Week 2, n=72, 74 | 0.4 Grams per liter | Standard Deviation 3.71 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin: Week 2, n=72, 74 | -0.4 Grams per liter | Standard Deviation 2.11 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 4, n=47,59 | -0.4 Grams per liter | Standard Deviation 3.76 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 12, n=24, 36 | -0.9 Grams per liter | Standard Deviation 2.69 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 8, n=34,47 | 0.8 Grams per liter | Standard Deviation 3.83 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 4, n=47,59 | -0.8 Grams per liter | Standard Deviation 2.62 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 12, n=24, 36 | -0.6 Grams per liter | Standard Deviation 4.79 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 28, n=74, 73 | -0.6 Grams per liter | Standard Deviation 2.99 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 16, n=24, 39 | 0.4 Grams per liter | Standard Deviation 3.34 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Albumin:Week 8, n=34,47 | 0.0 Grams per liter | Standard Deviation 2.38 |
| GSK3772847 | Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin | Total Protein:Week 28, n=74, 73 | -0.2 Grams per liter | Standard Deviation 4.27 |
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented.
Time frame: Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28
Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-DoseWeek8; n=34, 47 | -2.7 Millimeters of Mercury (mmHg) | Standard Deviation 9.81 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-dose: Week12; n=24, 39 | -0.7 Millimeters of Mercury (mmHg) | Standard Deviation 6.34 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-dose: Week0; n=82, 83 | -2.0 Millimeters of Mercury (mmHg) | Standard Deviation 8.05 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week1; n=79, 75 | -0.9 Millimeters of Mercury (mmHg) | Standard Deviation 9.61 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week2; n=73, 75 | -1.3 Millimeters of Mercury (mmHg) | Standard Deviation 10.73 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Pre-dose: Week4; n=49, 59 | -2.0 Millimeters of Mercury (mmHg) | Standard Deviation 8.88 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-dose: Week4; n=48, 59 | -2.0 Millimeters of Mercury (mmHg) | Standard Deviation 9.46 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP:Week6; n=45, 57 | -1.7 Millimeters of Mercury (mmHg) | Standard Deviation 9.33 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Pre-Dose:Week8; n=34, 47 | -1.9 Millimeters of Mercury (mmHg) | Standard Deviation 7.85 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week10; n=34, 46 | -2.5 Millimeters of Mercury (mmHg) | Standard Deviation 10.2 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Pre-dose: Week12; n=24, 39 | 0.3 Millimeters of Mercury (mmHg) | Standard Deviation 8.34 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week14; n=24, 39 | -1.6 Millimeters of Mercury (mmHg) | Standard Deviation 9.17 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week16; n=24, 39 | -2.8 Millimeters of Mercury (mmHg) | Standard Deviation 9.16 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week20; n=76, 78 | -1.0 Millimeters of Mercury (mmHg) | Standard Deviation 10.72 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week24; n=75, 76 | -2.4 Millimeters of Mercury (mmHg) | Standard Deviation 10.78 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week28; n=74, 77 | -1.3 Millimeters of Mercury (mmHg) | Standard Deviation 9.95 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-dose: Week0; n=82,83 | -0.7 Millimeters of Mercury (mmHg) | Standard Deviation 6.58 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week1; n=79, 75 | 0.3 Millimeters of Mercury (mmHg) | Standard Deviation 6.96 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week2; n=73, 75 | -0.7 Millimeters of Mercury (mmHg) | Standard Deviation 8.61 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Pre-dose: Week4; n=49, 59 | -1.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.26 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-dose: Week4; n=48, 59 | -0.4 Millimeters of Mercury (mmHg) | Standard Deviation 7.93 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP:Week6; n=45, 57 | 0.6 Millimeters of Mercury (mmHg) | Standard Deviation 7.72 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Pre-Dose:Week8; n=34, 47 | -0.4 Millimeters of Mercury (mmHg) | Standard Deviation 7.66 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-DoseWeek8; n=34, 47 | -0.1 Millimeters of Mercury (mmHg) | Standard Deviation 7.54 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week10; n=34, 46 | -0.1 Millimeters of Mercury (mmHg) | Standard Deviation 9.36 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Pre-dose: Week12; n=24, 39 | 0.3 Millimeters of Mercury (mmHg) | Standard Deviation 7.27 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-dose: Week12; n=24, 39 | 0.0 Millimeters of Mercury (mmHg) | Standard Deviation 8.08 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week14; n=24, 39 | 0.0 Millimeters of Mercury (mmHg) | Standard Deviation 5.28 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week24; n=75, 76 | 0.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.15 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week16; n=24, 39 | -0.3 Millimeters of Mercury (mmHg) | Standard Deviation 8.37 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week20; n=76, 78 | -0.4 Millimeters of Mercury (mmHg) | Standard Deviation 8.61 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week28; n=74, 77 | -0.3 Millimeters of Mercury (mmHg) | Standard Deviation 9.74 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week20; n=76, 78 | 0.7 Millimeters of Mercury (mmHg) | Standard Deviation 6.6 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-dose: Week0; n=82,83 | -0.3 Millimeters of Mercury (mmHg) | Standard Deviation 5.67 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week10; n=34, 46 | -0.2 Millimeters of Mercury (mmHg) | Standard Deviation 7.94 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-dose: Week0; n=82, 83 | 1.3 Millimeters of Mercury (mmHg) | Standard Deviation 7.19 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week1; n=79, 75 | 0.7 Millimeters of Mercury (mmHg) | Standard Deviation 8.29 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week1; n=79, 75 | 0.4 Millimeters of Mercury (mmHg) | Standard Deviation 9.67 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week24; n=75, 76 | 0.3 Millimeters of Mercury (mmHg) | Standard Deviation 7.06 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week2; n=73, 75 | -1.3 Millimeters of Mercury (mmHg) | Standard Deviation 10.58 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week2; n=73, 75 | -0.8 Millimeters of Mercury (mmHg) | Standard Deviation 7.04 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Pre-dose: Week4; n=49, 59 | -0.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.84 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Pre-dose: Week12; n=24, 39 | 0.6 Millimeters of Mercury (mmHg) | Standard Deviation 6.52 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-dose: Week4; n=48, 59 | 2.2 Millimeters of Mercury (mmHg) | Standard Deviation 10.72 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Pre-dose: Week4; n=49, 59 | 0.4 Millimeters of Mercury (mmHg) | Standard Deviation 7.72 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP:Week6; n=45, 57 | 0.9 Millimeters of Mercury (mmHg) | Standard Deviation 9.38 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week16; n=24, 39 | -0.5 Millimeters of Mercury (mmHg) | Standard Deviation 5.59 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Pre-Dose:Week8; n=34, 47 | 0.4 Millimeters of Mercury (mmHg) | Standard Deviation 7.91 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Pre-dose: Week12; n=24, 39 | 1.5 Millimeters of Mercury (mmHg) | Standard Deviation 10.19 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-DoseWeek8; n=34, 47 | 2.3 Millimeters of Mercury (mmHg) | Standard Deviation 9.46 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-dose: Week4; n=48, 59 | 0.3 Millimeters of Mercury (mmHg) | Standard Deviation 7.79 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week10; n=34, 46 | 0.7 Millimeters of Mercury (mmHg) | Standard Deviation 11.74 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-dose: Week12; n=24, 39 | -0.5 Millimeters of Mercury (mmHg) | Standard Deviation 6.79 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Post-dose: Week12; n=24, 39 | 3.3 Millimeters of Mercury (mmHg) | Standard Deviation 11.23 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP:Week6; n=45, 57 | -1.0 Millimeters of Mercury (mmHg) | Standard Deviation 7.32 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week14; n=24, 39 | 2.1 Millimeters of Mercury (mmHg) | Standard Deviation 10.47 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week28; n=74, 77 | -0.4 Millimeters of Mercury (mmHg) | Standard Deviation 7.62 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week16; n=24, 39 | 1.5 Millimeters of Mercury (mmHg) | Standard Deviation 10.37 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Pre-Dose:Week8; n=34, 47 | -2.0 Millimeters of Mercury (mmHg) | Standard Deviation 7.79 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week20; n=76, 78 | 1.7 Millimeters of Mercury (mmHg) | Standard Deviation 10.32 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Week14; n=24, 39 | 0.5 Millimeters of Mercury (mmHg) | Standard Deviation 6.84 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week24; n=75, 76 | 1.7 Millimeters of Mercury (mmHg) | Standard Deviation 10.46 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Post-DoseWeek8; n=34, 47 | -1.2 Millimeters of Mercury (mmHg) | Standard Deviation 7.21 |
| GSK3772847 | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Week28; n=74, 77 | 1.0 Millimeters of Mercury (mmHg) | Standard Deviation 9.77 |
Secondary
Change From Baseline in ECG Heart Rate
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16
Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in ECG Heart Rate | Post-dose: Week0; n=82, 83 | -1.6 Beats per minute | Standard Deviation 7.57 |
| Placebo | Change From Baseline in ECG Heart Rate | Pre-dose: Week4; n=49, 59 | 0.4 Beats per minute | Standard Deviation 9.06 |
| Placebo | Change From Baseline in ECG Heart Rate | Post-dose: Week4; n=48, 59 | -2.4 Beats per minute | Standard Deviation 9.09 |
| Placebo | Change From Baseline in ECG Heart Rate | Pre-dose: Week8; n=34, 47 | 1.5 Beats per minute | Standard Deviation 11.81 |
| Placebo | Change From Baseline in ECG Heart Rate | Post-dose: Week8; n=33, 47 | -0.3 Beats per minute | Standard Deviation 15.59 |
| Placebo | Change From Baseline in ECG Heart Rate | Pre-dose:Week12; n=24, 39 | 0.6 Beats per minute | Standard Deviation 8.98 |
| Placebo | Change From Baseline in ECG Heart Rate | Post-dose Week12; n=24, 39 | 0.4 Beats per minute | Standard Deviation 12.44 |
| Placebo | Change From Baseline in ECG Heart Rate | Week16; n=24, 39 | 0.5 Beats per minute | Standard Deviation 10.04 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Week16; n=24, 39 | 3.1 Beats per minute | Standard Deviation 8.12 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Post-dose: Week0; n=82, 83 | 0.2 Beats per minute | Standard Deviation 6.93 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Post-dose: Week8; n=33, 47 | -0.4 Beats per minute | Standard Deviation 7.57 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Pre-dose: Week4; n=49, 59 | 0.7 Beats per minute | Standard Deviation 7.94 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Post-dose Week12; n=24, 39 | 0.5 Beats per minute | Standard Deviation 9.28 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Post-dose: Week4; n=48, 59 | -1.0 Beats per minute | Standard Deviation 8.48 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Pre-dose:Week12; n=24, 39 | 1.6 Beats per minute | Standard Deviation 7.56 |
| GSK3772847 | Change From Baseline in ECG Heart Rate | Pre-dose: Week8; n=34, 47 | 1.9 Beats per minute | Standard Deviation 6.98 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Blood samples were collected for the analysis of erythrocyte mean corpuscular volume at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed . Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 4: n=49, 57 | -0.4 Femtoliters | Standard Deviation 1.62 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 10: n=34, 45 | -1.1 Femtoliters | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 2: n=71, 74 | 0.2 Femtoliters | Standard Deviation 1.44 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 12: n=24, 39 | -0.7 Femtoliters | Standard Deviation 1.46 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 6: n=44, 56 | -0.3 Femtoliters | Standard Deviation 1.29 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 14: n=24, 39 | -0.7 Femtoliters | Standard Deviation 1.63 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 1: n=78,74 | 0.3 Femtoliters | Standard Deviation 1.59 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 16: n=24, 39 | -0.6 Femtoliters | Standard Deviation 1.58 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 8: n=34, 47 | -0.9 Femtoliters | Standard Deviation 1.37 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 28: n=65, 63 | -1.6 Femtoliters | Standard Deviation 2.76 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 8: n=34, 47 | -0.6 Femtoliters | Standard Deviation 2.13 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 1: n=78,74 | -0.1 Femtoliters | Standard Deviation 1.46 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 2: n=71, 74 | -0.2 Femtoliters | Standard Deviation 1.62 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 4: n=49, 57 | -0.6 Femtoliters | Standard Deviation 1.98 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 6: n=44, 56 | -0.4 Femtoliters | Standard Deviation 2.33 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 28: n=65, 63 | -2.9 Femtoliters | Standard Deviation 5.2 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 10: n=34, 45 | -0.9 Femtoliters | Standard Deviation 2.52 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 12: n=24, 39 | -1.3 Femtoliters | Standard Deviation 2.61 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 14: n=24, 39 | -1.5 Femtoliters | Standard Deviation 2.46 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Week 16: n=24, 39 | -2.3 Femtoliters | Standard Deviation 2.67 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected for the analysis of erythrocytes at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 1: n=78,74 | -0.01 10^12 cells per liter | Standard Deviation 0.22 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 8: n=34, 47 | 0.02 10^12 cells per liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 16: n=24, 39 | 0.00 10^12 cells per liter | Standard Deviation 0.184 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 2: n=71, 74 | 0.01 10^12 cells per liter | Standard Deviation 0.232 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 4: n=49, 57 | 0.05 10^12 cells per liter | Standard Deviation 0.298 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 6: n=44, 56 | 0.05 10^12 cells per liter | Standard Deviation 0.181 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 10: n=34, 45 | 0.00 10^12 cells per liter | Standard Deviation 0.228 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 12: n=24, 39 | 0.06 10^12 cells per liter | Standard Deviation 0.226 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 14: n=24, 39 | 0.03 10^12 cells per liter | Standard Deviation 0.206 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes | Week 28: n=65, 63 | 0.09 10^12 cells per liter | Standard Deviation 0.26 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 12: n=24, 39 | -0.03 10^12 cells per liter | Standard Deviation 0.297 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 6: n=44, 56 | -0.04 10^12 cells per liter | Standard Deviation 0.17 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 8: n=34, 47 | 0.02 10^12 cells per liter | Standard Deviation 0.234 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 28: n=65, 63 | 0.09 10^12 cells per liter | Standard Deviation 0.381 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 16: n=24, 39 | 0.03 10^12 cells per liter | Standard Deviation 0.236 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 1: n=78,74 | -0.03 10^12 cells per liter | Standard Deviation 0.232 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 10: n=34, 45 | -0.02 10^12 cells per liter | Standard Deviation 0.201 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 2: n=71, 74 | 0.01 10^12 cells per liter | Standard Deviation 0.2 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 14: n=24, 39 | 0.04 10^12 cells per liter | Standard Deviation 0.253 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes | Week 4: n=49, 57 | -0.01 10^12 cells per liter | Standard Deviation 0.169 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Blood samples were collected for the analysis of Erythrocytes Distribution Width (%) at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 1: n=78,74 | -0.06 Percentage (%) of Erythrocytes | Standard Deviation 0.747 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 2: n=71, 74 | -0.02 Percentage (%) of Erythrocytes | Standard Deviation 0.478 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 4: n=49, 57 | -0.22 Percentage (%) of Erythrocytes | Standard Deviation 0.555 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 6: n=44, 56 | -0.33 Percentage (%) of Erythrocytes | Standard Deviation 0.545 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 8: n=34, 47 | -0.40 Percentage (%) of Erythrocytes | Standard Deviation 0.669 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 10: n=34, 45 | -0.35 Percentage (%) of Erythrocytes | Standard Deviation 0.791 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 12: n=24, 39 | -0.27 Percentage (%) of Erythrocytes | Standard Deviation 0.717 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 14: n=24, 39 | -0.28 Percentage (%) of Erythrocytes | Standard Deviation 0.873 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 16: n=24, 39 | -0.25 Percentage (%) of Erythrocytes | Standard Deviation 0.727 |
| Placebo | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 28: n=65, 63 | -0.09 Percentage (%) of Erythrocytes | Standard Deviation 1.028 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 14: n=24, 39 | -0.38 Percentage (%) of Erythrocytes | Standard Deviation 0.897 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 1: n=78,74 | -0.08 Percentage (%) of Erythrocytes | Standard Deviation 0.604 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 10: n=34, 45 | -0.38 Percentage (%) of Erythrocytes | Standard Deviation 1.049 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 2: n=71, 74 | -0.20 Percentage (%) of Erythrocytes | Standard Deviation 0.652 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 28: n=65, 63 | -0.01 Percentage (%) of Erythrocytes | Standard Deviation 1.202 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 4: n=49, 57 | -0.33 Percentage (%) of Erythrocytes | Standard Deviation 0.844 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 12: n=24, 39 | -0.34 Percentage (%) of Erythrocytes | Standard Deviation 0.916 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 6: n=44, 56 | -0.37 Percentage (%) of Erythrocytes | Standard Deviation 0.861 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 16: n=24, 39 | -0.41 Percentage (%) of Erythrocytes | Standard Deviation 0.995 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%) | Week 8: n=34, 47 | -0.29 Percentage (%) of Erythrocytes | Standard Deviation 0.96 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit Level
Blood samples were collected for the analysis of hematocrit at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 1: n=78,74 | 0.0007 Proportion of red blood cells in blood | Standard Deviation 0.02255 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 2: n=71, 74 | 0.0024 Proportion of red blood cells in blood | Standard Deviation 0.02213 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 4: n=49, 57 | 0.0038 Proportion of red blood cells in blood | Standard Deviation 0.02957 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 6: n=44, 56 | 0.0024 Proportion of red blood cells in blood | Standard Deviation 0.01557 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 8: n=34, 47 | -0.0019 Proportion of red blood cells in blood | Standard Deviation 0.01645 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 10: n=34, 45 | -0.0050 Proportion of red blood cells in blood | Standard Deviation 0.01897 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 12: n=24, 39 | 0.0009 Proportion of red blood cells in blood | Standard Deviation 0.0174 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 14: n=24, 39 | -0.0018 Proportion of red blood cells in blood | Standard Deviation 0.01699 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 16: n=24, 39 | -0.0042 Proportion of red blood cells in blood | Standard Deviation 0.01474 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 28: n=65, 63 | 0.0016 Proportion of red blood cells in blood | Standard Deviation 0.02283 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 14: n=24, 39 | -0.0038 Proportion of red blood cells in blood | Standard Deviation 0.02277 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 1: n=78,74 | -0.0025 Proportion of red blood cells in blood | Standard Deviation 0.02114 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 10: n=34, 45 | -0.0061 Proportion of red blood cells in blood | Standard Deviation 0.02175 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 2: n=71, 74 | -0.0046 Proportion of red blood cells in blood | Standard Deviation 0.04223 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 28: n=65, 63 | -0.0041 Proportion of red blood cells in blood | Standard Deviation 0.03153 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 4: n=49, 57 | -0.0033 Proportion of red blood cells in blood | Standard Deviation 0.01665 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 12: n=24, 39 | -0.0088 Proportion of red blood cells in blood | Standard Deviation 0.03342 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 6: n=44, 56 | -0.0050 Proportion of red blood cells in blood | Standard Deviation 0.0206 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 16: n=24, 39 | -0.0071 Proportion of red blood cells in blood | Standard Deviation 0.02232 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hematocrit Level | Week 8: n=34, 47 | -0.0015 Proportion of red blood cells in blood | Standard Deviation 0.02212 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected for the analysis of hemoglobin level at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 2: n=71, 74 | 0.5 Grams per liter | Standard Deviation 7.01 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 1: n=78,74 | 0.5 Grams per liter | Standard Deviation 7.08 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 12: n=24, 39 | 1.0 Grams per liter | Standard Deviation 6.5 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 4: n=49, 57 | 1.6 Grams per liter | Standard Deviation 8.84 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 14: n=24, 39 | -0.6 Grams per liter | Standard Deviation 6.08 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 10: n=34, 45 | -0.4 Grams per liter | Standard Deviation 5.71 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 16: n=24, 39 | -0.5 Grams per liter | Standard Deviation 5.44 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 6: n=44, 56 | 1.5 Grams per liter | Standard Deviation 4.6 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 28: n=65, 63 | 1.0 Grams per liter | Standard Deviation 8.2 |
| Placebo | Change From Baseline in Hematology Parameter: Hemoglobin | Week 8: n=34, 47 | 0.5 Grams per liter | Standard Deviation 6.16 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 28: n=65, 63 | -0.7 Grams per liter | Standard Deviation 10.24 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 8: n=34, 47 | -0.1 Grams per liter | Standard Deviation 6.72 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 1: n=78,74 | -0.7 Grams per liter | Standard Deviation 6.3 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 2: n=71, 74 | 0.0 Grams per liter | Standard Deviation 5.64 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 4: n=49, 57 | -0.4 Grams per liter | Standard Deviation 5.16 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 6: n=44, 56 | -1.2 Grams per liter | Standard Deviation 5.17 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 10: n=34, 45 | -0.8 Grams per liter | Standard Deviation 5.28 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 12: n=24, 39 | -1.8 Grams per liter | Standard Deviation 10.05 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 14: n=24, 39 | -0.3 Grams per liter | Standard Deviation 6.35 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Hemoglobin | Week 16: n=24, 39 | 0.0 Grams per liter | Standard Deviation 6.14 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Blood samples were collected for the analysis of mean corpuscular hemoglobin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 1: n=78,74 | 0.17 Picogram | Standard Deviation 0.725 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 2: n=71, 74 | 0.01 Picogram | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 4: n=49, 57 | 0.01 Picogram | Standard Deviation 0.461 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 6: n=44, 56 | 0.06 Picogram | Standard Deviation 0.416 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 8: n=34, 47 | 0.02 Picogram | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 10: n=34, 45 | -0.06 Picogram | Standard Deviation 0.59 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 12: n=24, 39 | -0.07 Picogram | Standard Deviation 0.543 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 14: n=24, 39 | -0.23 Picogram | Standard Deviation 0.421 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 16: n=24, 39 | -0.05 Picogram | Standard Deviation 0.475 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 28: n=65, 63 | -0.40 Picogram | Standard Deviation 0.649 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 14: n=24, 39 | -0.29 Picogram | Standard Deviation 0.785 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 1: n=78,74 | 0.01 Picogram | Standard Deviation 0.453 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 10: n=34, 45 | -0.01 Picogram | Standard Deviation 0.863 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 2: n=71, 74 | -0.07 Picogram | Standard Deviation 0.471 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 28: n=65, 63 | -0.78 Picogram | Standard Deviation 1.773 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 4: n=49, 57 | -0.04 Picogram | Standard Deviation 0.432 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 12: n=24, 39 | -0.12 Picogram | Standard Deviation 0.776 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 6: n=44, 56 | 0.00 Picogram | Standard Deviation 0.551 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 16: n=24, 39 | -0.26 Picogram | Standard Deviation 0.839 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | Week 8: n=34, 47 | -0.11 Picogram | Standard Deviation 0.567 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Blood samples were collected for the analysis of mean corpuscular hemoglobin concentration at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 4: n=49, 57 | 1.2 Grams per liter | Standard Deviation 7.01 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 1: n=78,74 | 0.8 Grams per liter | Standard Deviation 8.29 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 2: n=71, 74 | -0.6 Grams per liter | Standard Deviation 6.04 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 6: n=44, 56 | 1.9 Grams per liter | Standard Deviation 5.33 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 8: n=34, 47 | 3.0 Grams per liter | Standard Deviation 7.65 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 10: n=34, 45 | 3.3 Grams per liter | Standard Deviation 6.68 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 12: n=24, 39 | 2.3 Grams per liter | Standard Deviation 6.29 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 14: n=24, 39 | 0.4 Grams per liter | Standard Deviation 6.47 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 16: n=24, 39 | 2.1 Grams per liter | Standard Deviation 7.01 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 28: n=65, 63 | 1.2 Grams per liter | Standard Deviation 8.36 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 14: n=24, 39 | 2.4 Grams per liter | Standard Deviation 8.97 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 4: n=49, 57 | 1.5 Grams per liter | Standard Deviation 7.32 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 10: n=34, 45 | 3.4 Grams per liter | Standard Deviation 10.17 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 1: n=78,74 | 0.5 Grams per liter | Standard Deviation 6.65 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 28: n=65, 63 | 1.5 Grams per liter | Standard Deviation 8.78 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 2: n=71, 74 | 0.2 Grams per liter | Standard Deviation 7.09 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 12: n=24, 39 | 3.2 Grams per liter | Standard Deviation 10.32 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 6: n=44, 56 | 1.3 Grams per liter | Standard Deviation 9.33 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 16: n=24, 39 | 5.7 Grams per liter | Standard Deviation 9.6 |
| GSK3772847 | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration | Week 8: n=34, 47 | 1.1 Grams per liter | Standard Deviation 7.56 |
Secondary
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Blood samples were collected at given time points to assess hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, leutrophils, monocytes, and platelets . Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 10; n=32, 44 | 0.103 10^9 cells per liter | Standard Deviation 0.4275 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 16; n=23, 39 | -0.018 10^9 cells per liter | Standard Deviation 0.2456 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 12; n=24, 39 | 0.098 10^9 cells per liter | Standard Deviation 0.3657 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 10; n= 32, 44 | 0.004 10^9 cells per liter | Standard Deviation 0.0345 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 14; n=23, 39 | 0.009 10^9 cells per liter | Standard Deviation 0.359 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 28; n= 65, 60 | 0.010 10^9 cells per liter | Standard Deviation 0.2077 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 16; n=23, 39 | 0.02 10^9 cells per liter | Standard Deviation 0.3825 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil: Week 1; n=77, 74 | -0.031 10^9 cells per liter | Standard Deviation 0.2868 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 28; n=65, 60 | 0.065 10^9 cells per liter | Standard Deviation 0.4601 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes: Week 1; n=78, 74 | 0.14 10^9 cells per liter | Standard Deviation 1.614 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils: Week 1; n=77, 74 | 0.079 10^9 cells per liter | Standard Deviation 1.4665 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 6; n=43, 54 | 0.006 10^9 cells per liter | Standard Deviation 0.042 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 2; n=68, 72 | 0.023 10^9 cells per liter | Standard Deviation 1.0414 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 2; n= 68, 73 | 0.01 10^9 cells per liter | Standard Deviation 1.202 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 4; n=48, 57 | 0.187 10^9 cells per liter | Standard Deviation 1.2738 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 2; n=68, 72 | -0.050 10^9 cells per liter | Standard Deviation 0.2105 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 6; n=43, 54 | 0.203 10^9 cells per liter | Standard Deviation 1.3952 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 4; n =48, 57 | 0.24 10^9 cells per liter | Standard Deviation 1.406 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 8; n=33, 46 | -0.080 10^9 cells per liter | Standard Deviation 0.9654 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 12; n=24, 39 | 0.010 10^9 cells per liter | Standard Deviation 0.0262 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 10; n=32, 44 | -0.192 10^9 cells per liter | Standard Deviation 0.9739 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 6; n=43, 54 | 0.37 10^9 cells per liter | Standard Deviation 1.346 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 12; n=24, 39 | -0.013 10^9 cells per liter | Standard Deviation 1.2306 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 4; n=48, 57 | -0.048 10^9 cells per liter | Standard Deviation 0.2585 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 14; n=23, 39 | -0.263 10^9 cells per liter | Standard Deviation 1.3117 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 8; n=33, 47 | 0.08 10^9 cells per liter | Standard Deviation 1.045 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 16; n=23, 39 | -0.448 10^9 cells per liter | Standard Deviation 1.1201 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 4; n=48, 57 | 0.005 10^9 cells per liter | Standard Deviation 0.0341 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 28; n=65, 60 | -0.201 10^9 cells per liter | Standard Deviation 1.5148 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 10; n=33, 45 | 0.01 10^9 cells per liter | Standard Deviation 1.102 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes: Week 1; n=77, 74 | 0.026 10^9 cells per liter | Standard Deviation 0.1595 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 6; n =43, 54 | -0.023 10^9 cells per liter | Standard Deviation 0.2714 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 2; n=68, 72 | 0.020 10^9 cells per liter | Standard Deviation 0.1226 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 12; n=24, 39 | 0.13 10^9 cells per liter | Standard Deviation 1.257 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 4; n=48, 57 | 0.051 10^9 cells per liter | Standard Deviation 0.1869 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 14; n=23, 39 | -0.003 10^9 cells per liter | Standard Deviation 0.0255 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 6; n=43, 54 | 0.050 10^9 cells per liter | Standard Deviation 0.1353 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 14; n= 23, 39 | -0.17 10^9 cells per liter | Standard Deviation 1.324 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 8; n=33, 46 | 0.045 10^9 cells per liter | Standard Deviation 0.1152 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 8; n= 33, 46 | -0.014 10^9 cells per liter | Standard Deviation 0.2069 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 10; n=32, 44 | 0.090 10^9 cells per liter | Standard Deviation 0.1463 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 16; n=23, 39 | -0.41 10^9 cells per liter | Standard Deviation 1.296 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 12; n=24, 39 | 0.073 10^9 cells per liter | Standard Deviation 0.1362 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 8; n=33, 46 | 0.002 10^9 cells per liter | Standard Deviation 0.0449 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 14; n=23, 39 | 0.059 10^9 cells per liter | Standard Deviation 0.1301 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 28; n=65, 63 | -0.08 10^9 cells per liter | Standard Deviation 1.545 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 16; n=23, 39 | 0.040 10^9 cells per liter | Standard Deviation 0.1087 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 10 n=32, 44 | 0.000 10^9 cells per liter | Standard Deviation 0.2387 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 28; n=65, 60 | 0.041 10^9 cells per liter | Standard Deviation 0.1431 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes: Week 1; n=77, 74 | 0.036 10^9 cells per liter | Standard Deviation 0.4248 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets: Week 1; n=78, 74 | 1.5 10^9 cells per liter | Standard Deviation 31.89 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 16; n=23, 39 | -0.005 10^9 cells per liter | Standard Deviation 0.0316 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 2; n=71, 74 | 7.6 10^9 cells per liter | Standard Deviation 35.72 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 2; n=68, 72 | 0.006 10^9 cells per liter | Standard Deviation 0.3437 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 4; n=49, 57 | 4.0 10^9 cells per liter | Standard Deviation 27.64 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 12; n=24, 39 | -0.039 10^9 cells per liter | Standard Deviation 0.2621 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 6; n=44, 56 | 18.2 10^9 cells per liter | Standard Deviation 46.02 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 4; n=48, 57 | 0.043 10^9 cells per liter | Standard Deviation 0.4048 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 8; n=34, 47 | 8.6 10^9 cells per liter | Standard Deviation 38.79 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 2; n= 68, 72 | 0.003 10^9 cells per liter | Standard Deviation 0.035 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 10; n=34, 45 | 10.9 10^9 cells per liter | Standard Deviation 45.93 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 6; n=43, 54 | 0.140 10^9 cells per liter | Standard Deviation 0.4994 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 12; n=24, 39 | 3.6 10^9 cells per liter | Standard Deviation 46.24 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 14; n=23, 39 | 0.018 10^9 cells per liter | Standard Deviation 0.1888 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 14; n=24, 39 | -6.4 10^9 cells per liter | Standard Deviation 45.37 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 8; n=33, 46 | 0.132 10^9 cells per liter | Standard Deviation 0.3257 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 16; n=24, 38 | -0.5 10^9 cells per liter | Standard Deviation 37.57 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 28; n= 65, 60 | 0.006 10^9 cells per liter | Standard Deviation 0.0364 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 28; n=64, 62 | -3.5 10^9 cells per liter | Standard Deviation 35.52 |
| Placebo | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil: Week 1; n=77, 74 | 0.001 10^9 cells per liter | Standard Deviation 0.0361 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 28; n=64, 62 | 3.0 10^9 cells per liter | Standard Deviation 52.16 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil: Week 1; n=77, 74 | -0.001 10^9 cells per liter | Standard Deviation 0.0396 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 2; n= 68, 72 | 0.005 10^9 cells per liter | Standard Deviation 0.0346 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 4; n=48, 57 | 0.004 10^9 cells per liter | Standard Deviation 0.0409 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 6; n=43, 54 | 0.007 10^9 cells per liter | Standard Deviation 0.0363 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 8; n=33, 46 | -0.001 10^9 cells per liter | Standard Deviation 0.0366 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 10; n= 32, 44 | 0.010 10^9 cells per liter | Standard Deviation 0.0367 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 12; n=24, 39 | 0.010 10^9 cells per liter | Standard Deviation 0.0312 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 14; n=23, 39 | 0.012 10^9 cells per liter | Standard Deviation 0.0338 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 16; n=23, 39 | 0.006 10^9 cells per liter | Standard Deviation 0.0409 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophil:Week 28; n= 65, 60 | 0.007 10^9 cells per liter | Standard Deviation 0.0353 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil: Week 1; n=77, 74 | -0.038 10^9 cells per liter | Standard Deviation 0.1424 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 2; n=68, 72 | -0.051 10^9 cells per liter | Standard Deviation 0.1892 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 4; n=48, 57 | -0.119 10^9 cells per liter | Standard Deviation 0.1522 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 6; n =43, 54 | -0.119 10^9 cells per liter | Standard Deviation 0.195 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 8; n= 33, 46 | -0.096 10^9 cells per liter | Standard Deviation 0.2134 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 10 n=32, 44 | -0.041 10^9 cells per liter | Standard Deviation 0.2371 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 12; n=24, 39 | -0.066 10^9 cells per liter | Standard Deviation 0.1939 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 14; n=23, 39 | -0.034 10^9 cells per liter | Standard Deviation 0.2481 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 16; n=23, 39 | -0.093 10^9 cells per liter | Standard Deviation 0.235 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophil:Week 28; n= 65, 60 | -0.087 10^9 cells per liter | Standard Deviation 0.1865 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes: Week 1; n=78, 74 | 0.07 10^9 cells per liter | Standard Deviation 1.314 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 2; n= 68, 73 | 0.09 10^9 cells per liter | Standard Deviation 1.117 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 4; n =48, 57 | 0.19 10^9 cells per liter | Standard Deviation 1.401 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 6; n=43, 54 | -0.12 10^9 cells per liter | Standard Deviation 1.04 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 8; n=33, 47 | 0.14 10^9 cells per liter | Standard Deviation 2.248 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 10; n=33, 45 | 0.03 10^9 cells per liter | Standard Deviation 1.259 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 12; n=24, 39 | 0.18 10^9 cells per liter | Standard Deviation 1.038 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 14; n= 23, 39 | 0.26 10^9 cells per liter | Standard Deviation 1.22 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 16; n=23, 39 | 0.18 10^9 cells per liter | Standard Deviation 1.511 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes:Week 28; n=65, 63 | 0.09 10^9 cells per liter | Standard Deviation 1.392 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes: Week 1; n=77, 74 | -0.008 10^9 cells per liter | Standard Deviation 0.3292 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 2; n=68, 72 | 0.039 10^9 cells per liter | Standard Deviation 0.4112 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 4; n=48, 57 | 0.061 10^9 cells per liter | Standard Deviation 0.2995 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 6; n=43, 54 | 0.086 10^9 cells per liter | Standard Deviation 0.3986 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 8; n=33, 46 | 0.033 10^9 cells per liter | Standard Deviation 0.3477 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 10; n=32, 44 | 0.105 10^9 cells per liter | Standard Deviation 0.4105 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 12; n=24, 39 | 0.044 10^9 cells per liter | Standard Deviation 0.3546 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 14; n=23, 39 | 0.119 10^9 cells per liter | Standard Deviation 0.4346 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 16; n=23, 39 | 0.075 10^9 cells per liter | Standard Deviation 0.4397 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes:Week 28; n=65, 60 | 0.162 10^9 cells per liter | Standard Deviation 0.4794 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils: Week 1; n=77, 74 | 0.092 10^9 cells per liter | Standard Deviation 1.1019 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 2; n=68, 72 | 0.035 10^9 cells per liter | Standard Deviation 0.8299 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 4; n=48, 57 | 0.217 10^9 cells per liter | Standard Deviation 1.2788 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 6; n=43, 54 | -0.126 10^9 cells per liter | Standard Deviation 0.8524 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 8; n=33, 46 | 0.331 10^9 cells per liter | Standard Deviation 2.0776 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 10; n=32, 44 | 0.041 10^9 cells per liter | Standard Deviation 0.9173 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 12; n=24, 39 | 0.158 10^9 cells per liter | Standard Deviation 0.863 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 14; n=23, 39 | 0.073 10^9 cells per liter | Standard Deviation 0.9305 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 16; n=23, 39 | 0.142 10^9 cells per liter | Standard Deviation 1.2595 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils:Week 28; n=65, 60 | -0.045 10^9 cells per liter | Standard Deviation 1.1145 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes: Week 1; n=77, 74 | 0.015 10^9 cells per liter | Standard Deviation 0.1209 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 2; n=68, 72 | 0.022 10^9 cells per liter | Standard Deviation 0.0965 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 4; n=48, 57 | 0.027 10^9 cells per liter | Standard Deviation 0.1014 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 6; n=43, 54 | 0.038 10^9 cells per liter | Standard Deviation 0.1083 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 8; n=33, 46 | 0.023 10^9 cells per liter | Standard Deviation 0.1038 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 10; n=32, 44 | 0.038 10^9 cells per liter | Standard Deviation 0.1 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 12; n=24, 39 | 0.025 10^9 cells per liter | Standard Deviation 0.0948 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 14; n=23, 39 | 0.082 10^9 cells per liter | Standard Deviation 0.103 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 16; n=23, 39 | 0.053 10^9 cells per liter | Standard Deviation 0.1075 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes:Week 28; n=65, 60 | 0.066 10^9 cells per liter | Standard Deviation 0.1218 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets: Week 1; n=78, 74 | 8.7 10^9 cells per liter | Standard Deviation 44.52 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 2; n=71, 74 | 9.8 10^9 cells per liter | Standard Deviation 44.42 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 4; n=49, 57 | 5.3 10^9 cells per liter | Standard Deviation 33.05 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 6; n=44, 56 | 3.9 10^9 cells per liter | Standard Deviation 35.62 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 8; n=34, 47 | -1.1 10^9 cells per liter | Standard Deviation 30.31 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 10; n=34, 45 | 4.7 10^9 cells per liter | Standard Deviation 30.88 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 12; n=24, 39 | 6.6 10^9 cells per liter | Standard Deviation 27.79 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 14; n=24, 39 | 5.5 10^9 cells per liter | Standard Deviation 32.66 |
| GSK3772847 | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets:Week 16; n=24, 38 | 6.3 10^9 cells per liter | Standard Deviation 40.13 |
Secondary
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Using a Holter monitor, maximum, minimum and average changes in heart rate was recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 0, 4 and 12
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Mean Heart Rate: Week4; n=49, 58 | 76.8 Beats per minute | Standard Deviation 10.6 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Maximum Heart Rate: Week12; n=24, 37 | 128.5 Beats per minute | Standard Deviation 15.21 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Maximum Heart Rate: Week0; n=81, 80 | -0.3 Beats per minute | Standard Deviation 13.13 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Minimum Heart Rate: Week0; n=81, 80 | -0.8 Beats per minute | Standard Deviation 5.08 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Mean Heart Rate: Week12; n=24, 37 | 78.8 Beats per minute | Standard Deviation 11.12 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Minimum Heart Rate: Week4; n=49, 58 | 50.6 Beats per minute | Standard Deviation 7.49 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Maximum Heart Rate: Week4; n=49, 58 | 128.3 Beats per minute | Standard Deviation 13.03 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Minimum Heart Rate: Week12; n=24, 37 | 53.6 Beats per minute | Standard Deviation 7.49 |
| Placebo | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Mean Heart Rate: Week0; n=81, 80 | -1.1 Beats per minute | Standard Deviation 6.56 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Minimum Heart Rate: Week12; n=24, 37 | 53.4 Beats per minute | Standard Deviation 9.09 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Mean Heart Rate: Week0; n=81, 80 | -2.0 Beats per minute | Standard Deviation 6 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Mean Heart Rate: Week4; n=49, 58 | 80.0 Beats per minute | Standard Deviation 10.8 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Mean Heart Rate: Week12; n=24, 37 | 79.9 Beats per minute | Standard Deviation 10.08 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Maximum Heart Rate: Week0; n=81, 80 | -5.0 Beats per minute | Standard Deviation 14.55 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Maximum Heart Rate: Week4; n=49, 58 | 130.3 Beats per minute | Standard Deviation 16.41 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Maximum Heart Rate: Week12; n=24, 37 | 132.1 Beats per minute | Standard Deviation 15.8 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Minimum Heart Rate: Week0; n=81, 80 | -0.8 Beats per minute | Standard Deviation 4.55 |
| GSK3772847 | Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate | Minimum Heart Rate: Week4; n=49, 58 | 53.8 Beats per minute | Standard Deviation 8.15 |
Secondary
Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol)
The mean number of inhalation of rescue medication (albuterol/salbutamol) used to relieve symptoms immediately during the day and night was recorded in eDiary from Baseline until Week 16. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean rescue medication use was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 13-16, n=24, 37 | 0.01 Inhalations per day | Standard Deviation 2.005 |
| Placebo | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 1-4, n=78, 75 | -0.52 Inhalations per day | Standard Deviation 2.554 |
| Placebo | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 5-8, n=56, 57 | -0.52 Inhalations per day | Standard Deviation 1.74 |
| Placebo | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 9-12, n=32, 42 | -0.17 Inhalations per day | Standard Deviation 0.945 |
| GSK3772847 | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 9-12, n=32, 42 | -1.59 Inhalations per day | Standard Deviation 5.934 |
| GSK3772847 | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 13-16, n=24, 37 | -1.90 Inhalations per day | Standard Deviation 6.624 |
| GSK3772847 | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 5-8, n=56, 57 | -1.24 Inhalations per day | Standard Deviation 5.18 |
| GSK3772847 | Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol) | Weeks 1-4, n=78, 75 | -1.09 Inhalations per day | Standard Deviation 4.687 |
Secondary
Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period
Asthma symptoms experienced by participants during the day was recorded in e-Diary every evening before going to bed in form of scores on a 5-point rating scale. Scores ranged from 0=no daytime asthma symptoms to 4=very severe daytime asthma symptoms. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean asthma symptom score was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 1-4, n=77, 78 | -0.09 Scores on a scale | Standard Deviation 0.472 |
| Placebo | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 5-8, n=52, 59 | -0.18 Scores on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 9-12 ,n=33,34 | -0.29 Scores on a scale | Standard Deviation 0.631 |
| Placebo | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 13-16, n=21, 38 | -0.29 Scores on a scale | Standard Deviation 0.692 |
| GSK3772847 | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 13-16, n=21, 38 | -0.17 Scores on a scale | Standard Deviation 0.458 |
| GSK3772847 | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 1-4, n=77, 78 | -0.02 Scores on a scale | Standard Deviation 0.337 |
| GSK3772847 | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 9-12 ,n=33,34 | -0.08 Scores on a scale | Standard Deviation 0.473 |
| GSK3772847 | Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period | Weeks 5-8, n=52, 59 | -0.09 Scores on a scale | Standard Deviation 0.46 |
Secondary
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
PEF is maximum speed of expiration measured, using spirometer. The device was distributed to participants at Visit 1, to measure PEF twice-daily (morning upon waking & in the evening just before going to bed). Participants were encouraged to perform morning & evening PEF measurements before the use of any long-acting beta-agonists (LABAs) or rescue medication. Highest of 3 values were recorded in eDairy.Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mean PEF was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16).Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment
Time frame: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16.
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 1-4,n=76, 76 | 4.13 Liters/minute | Standard Deviation 35.492 |
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 5-8,n=50, 56 | -1.84 Liters/minute | Standard Deviation 65.222 |
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 9-12,n=31, 43 | -4.15 Liters/minute | Standard Deviation 46.588 |
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 13-16,n=20, 38 | -7.88 Liters/minute | Standard Deviation 47.19 |
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 1-4,n=76, 77 | 0.43 Liters/minute | Standard Deviation 36.087 |
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 5-8,n=52, 58 | -6.96 Liters/minute | Standard Deviation 61.987 |
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 9-12,n=33, 44 | -0.77 Liters/minute | Standard Deviation 54.768 |
| Placebo | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 13-16,n=21, 38 | -10.81 Liters/minute | Standard Deviation 51.566 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 13-16,n=21, 38 | -1.16 Liters/minute | Standard Deviation 63.383 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 1-4,n=76, 76 | 4.32 Liters/minute | Standard Deviation 43.773 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 1-4,n=76, 77 | 2.45 Liters/minute | Standard Deviation 37.712 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 5-8,n=50, 56 | -3.82 Liters/minute | Standard Deviation 46.621 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 9-12,n=33, 44 | -0.58 Liters/minute | Standard Deviation 39.929 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 9-12,n=31, 43 | -1.69 Liters/minute | Standard Deviation 45.192 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Evening PEF: Weeks 5-8,n=52, 58 | -4.38 Liters/minute | Standard Deviation 49.076 |
| GSK3772847 | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF | Morning PEF: Weeks 13-16,n=20, 38 | -1.83 Liters/minute | Standard Deviation 69.866 |
Secondary
Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use
Participant captured night-time awakenings (yes/no) and use of rescue medication during these awakenings (yes/no) was recorded in e-Diary each morning. Percentage of night-time awakenings is calculated by number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data available\*100. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants having at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Night-time awakenings due to asthma symptoms requiring rescue medication was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 1-4, n=77, 76 | -3.80 Percentage of nights with awakenings | Standard Deviation 25.712 |
| Placebo | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 5-8,n=50, 56 | -7.85 Percentage of nights with awakenings | Standard Deviation 26.325 |
| Placebo | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 9-12,n=31, 43 | -5.67 Percentage of nights with awakenings | Standard Deviation 24.669 |
| Placebo | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 13-16,n=20, 38 | -2.31 Percentage of nights with awakenings | Standard Deviation 30.355 |
| GSK3772847 | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 13-16,n=20, 38 | -14.91 Percentage of nights with awakenings | Standard Deviation 33.544 |
| GSK3772847 | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 1-4, n=77, 76 | -7.42 Percentage of nights with awakenings | Standard Deviation 23.847 |
| GSK3772847 | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 9-12,n=31, 43 | -13.43 Percentage of nights with awakenings | Standard Deviation 26.962 |
| GSK3772847 | Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use | Weeks 5-8,n=50, 56 | -10.49 Percentage of nights with awakenings | Standard Deviation 31.081 |
Secondary
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Pre-bronchodilator FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the latest available assessment prior to first dose (Day 1) and change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 2, 4, 6, 8, 10, 12, 14 and 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week2; n=64, 66 | 0.094 Liters | Standard Deviation 0.2359 |
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week10; n=33, 43 | 0.047 Liters | Standard Deviation 0.2563 |
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week12; n=23, 36 | 0.061 Liters | Standard Deviation 0.2759 |
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week6; n=38, 50 | 0.078 Liters | Standard Deviation 0.261 |
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week14; n=21, 36 | 0.079 Liters | Standard Deviation 0.2824 |
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week4; n=48, 56 | 0.074 Liters | Standard Deviation 0.3077 |
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week16; n=15, 26 | 0.063 Liters | Standard Deviation 0.3383 |
| Placebo | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week8; n=33, 45 | 0.049 Liters | Standard Deviation 0.2888 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week16; n=15, 26 | 0.025 Liters | Standard Deviation 0.3008 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week2; n=64, 66 | 0.089 Liters | Standard Deviation 0.2443 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week4; n=48, 56 | 0.086 Liters | Standard Deviation 0.2325 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week6; n=38, 50 | 0.135 Liters | Standard Deviation 0.3758 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week8; n=33, 45 | 0.089 Liters | Standard Deviation 0.2236 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week12; n=23, 36 | 0.037 Liters | Standard Deviation 0.2637 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week14; n=21, 36 | 0.047 Liters | Standard Deviation 0.32 |
| GSK3772847 | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Week10; n=33, 43 | 0.066 Liters | Standard Deviation 0.2372 |
Secondary
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Post-dose: Week4; n=48, 59 | 1.2 milliseconds | Standard Deviation 9.74 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Pre-dose: Week8; n=33, 47 | 6.7 milliseconds | Standard Deviation 30.69 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS: Post-dose:Week4; n=48, 59 | -0.2 milliseconds | Standard Deviation 6.1 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT Pre-dose:Week12; n=24, 39 | 1.5 milliseconds | Standard Deviation 22.31 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Pre-dose:Week12; n=24, 39 | -1.3 milliseconds | Standard Deviation 9.51 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Post-dose:Week12; n=24, 39 | 3.3 milliseconds | Standard Deviation 24.38 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Pre-dose:Week8; n=34, 47 | 0.2 milliseconds | Standard Deviation 5.86 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Week16; n=24,39 | -2.2 milliseconds | Standard Deviation 21.15 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Pre-dose: Week4; n=49, 59 | -0.4 milliseconds | Standard Deviation 7.91 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose:Week0; n=80, 80 | 4.2 milliseconds | Standard Deviation 12.56 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Pre-dose:Week8; n=34, 47 | -17.4 milliseconds | Standard Deviation 135.17 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Pre-dose:Week4; n=49, 59 | -1.4 milliseconds | Standard Deviation 11.35 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Post-dose:Week8; n=33, 47 | 0.5 milliseconds | Standard Deviation 7.02 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose:Week4; n=48, 59 | 4.0 milliseconds | Standard Deviation 13.57 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Post-dose Week12; n=24, 39 | 1.3 milliseconds | Standard Deviation 10.85 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Pre-dose:Week8; n=34, 47 | 6.4 milliseconds | Standard Deviation 13 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Pre-dose: Week12; n=24, 39 | -1.3 milliseconds | Standard Deviation 4.83 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose:Week8; n=33, 47 | 5.5 milliseconds | Standard Deviation 12.86 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Pre-dose: Week8; n=34, 47 | 0.0 milliseconds | Standard Deviation 8.69 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Pre-dose:Week12; n=24, 39 | 3.3 milliseconds | Standard Deviation 13.45 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Post-dose: Week12; n=24, 39 | -0.7 milliseconds | Standard Deviation 6.03 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose: Week12; n=24, 39 | 4.4 milliseconds | Standard Deviation 13.91 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Week16; n=24, 39 | -0.6 milliseconds | Standard Deviation 10.22 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF: Week16; n=24, 39 | -0.5 milliseconds | Standard Deviation 11.87 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Week16; n=24, 39 | -1.6 milliseconds | Standard Deviation 6.19 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose: Week0; n=80, 80 | 24.0 milliseconds | Standard Deviation 104.42 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Post-dose: Week0; n=80, 80 | 1.8 milliseconds | Standard Deviation 9.77 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Pre-dose: Week4; n=49, 59 | -1.3 milliseconds | Standard Deviation 114.81 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Post-dose: Week0; n=80, 80 | 7.4 milliseconds | Standard Deviation 19.67 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose: Week4; n=48, 59 | 36.2 milliseconds | Standard Deviation 118.51 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Post-dose Week0; n=80, 80 | 0.0 milliseconds | Standard Deviation 5.75 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Pre-dose: Week4; n=49, 59 | -1.7 milliseconds | Standard Deviation 21.48 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose:Week8; n=33, 47 | 10.8 milliseconds | Standard Deviation 176.36 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR:Post-dose: Week8; n=33, 47 | 0.5 milliseconds | Standard Deviation 11.47 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Pre-dose:Week12; n=24, 39 | -12.6 milliseconds | Standard Deviation 107.36 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Post-dose: Week4; n=48, 59 | 8.9 milliseconds | Standard Deviation 23.09 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose:Week12; n=24, 39 | -4.8 milliseconds | Standard Deviation 148.89 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Pre-dose Week4; n=49, 59 | -0.5 milliseconds | Standard Deviation 5.69 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Week16; n=24, 39 | -14.4 milliseconds | Standard Deviation 113.07 |
| Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Pre-dose: Week8; n=34, 47 | 3.5 milliseconds | Standard Deviation 23.67 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose:Week0; n=80, 80 | 3.8 milliseconds | Standard Deviation 11.21 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Post-dose: Week0; n=80, 80 | 3.1 milliseconds | Standard Deviation 9.28 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Pre-dose: Week4; n=49, 59 | 1.3 milliseconds | Standard Deviation 10.93 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Post-dose: Week4; n=48, 59 | 1.9 milliseconds | Standard Deviation 11.76 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Pre-dose: Week8; n=34, 47 | 1.4 milliseconds | Standard Deviation 11.7 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR:Post-dose: Week8; n=33, 47 | 1.5 milliseconds | Standard Deviation 11.3 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Pre-dose:Week12; n=24, 39 | -0.5 milliseconds | Standard Deviation 13.17 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Post-dose Week12; n=24, 39 | 2.2 milliseconds | Standard Deviation 12.59 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | PR: Week16; n=24, 39 | -0.7 milliseconds | Standard Deviation 12.91 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Post-dose Week0; n=80, 80 | 0.2 milliseconds | Standard Deviation 5.6 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Pre-dose Week4; n=49, 59 | 0.7 milliseconds | Standard Deviation 5.72 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS: Post-dose:Week4; n=48, 59 | 0.1 milliseconds | Standard Deviation 6.14 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Pre-dose:Week8; n=34, 47 | -0.1 milliseconds | Standard Deviation 4.9 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Post-dose:Week8; n=33, 47 | 0.1 milliseconds | Standard Deviation 4.87 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Pre-dose: Week12; n=24, 39 | -1.1 milliseconds | Standard Deviation 7.13 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Post-dose: Week12; n=24, 39 | -1.8 milliseconds | Standard Deviation 6.21 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QRS:Week16; n=24, 39 | -2.0 milliseconds | Standard Deviation 6.25 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Post-dose: Week0; n=80, 80 | 3.5 milliseconds | Standard Deviation 16.69 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Pre-dose: Week4; n=49, 59 | -1.8 milliseconds | Standard Deviation 17.93 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Post-dose: Week4; n=48, 59 | 5.1 milliseconds | Standard Deviation 18.78 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Pre-dose: Week8; n=34, 47 | -4.7 milliseconds | Standard Deviation 20.53 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Pre-dose: Week8; n=33, 47 | 7.0 milliseconds | Standard Deviation 23.49 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT Pre-dose:Week12; n=24, 39 | -3.1 milliseconds | Standard Deviation 23.54 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Post-dose:Week12; n=24, 39 | 2.4 milliseconds | Standard Deviation 23.16 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QT:Week16; n=24,39 | -7.3 milliseconds | Standard Deviation 20.68 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Pre-dose:Week4; n=49, 59 | -1.0 milliseconds | Standard Deviation 12.1 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose:Week4; n=48, 59 | 2.0 milliseconds | Standard Deviation 12.46 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Pre-dose:Week8; n=34, 47 | -0.9 milliseconds | Standard Deviation 14.54 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose:Week8; n=33, 47 | 5.8 milliseconds | Standard Deviation 16.08 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Pre-dose:Week12; n=24, 39 | 0.4 milliseconds | Standard Deviation 17.56 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF:Post-dose: Week12; n=24, 39 | 2.9 milliseconds | Standard Deviation 14.33 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | QTcF: Week16; n=24, 39 | -2.2 milliseconds | Standard Deviation 14.83 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose: Week0; n=80, 80 | -0.2 milliseconds | Standard Deviation 89.38 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Pre-dose: Week4; n=49, 59 | -2.0 milliseconds | Standard Deviation 96.2 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose: Week4; n=48, 59 | 26.7 milliseconds | Standard Deviation 110.84 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Pre-dose:Week8; n=34, 47 | -24.2 milliseconds | Standard Deviation 92.65 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose:Week8; n=33, 47 | 10.7 milliseconds | Standard Deviation 97.02 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Pre-dose:Week12; n=24, 39 | -21.6 milliseconds | Standard Deviation 100.97 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Post-dose:Week12; n=24, 39 | 1.3 milliseconds | Standard Deviation 118.83 |
| GSK3772847 | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval | RR:Week16; n=24, 39 | -33.9 milliseconds | Standard Deviation 102.02 |
Secondary
Change From Baseline in Pulse Rate (PR)
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented.
Time frame: Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28
Population: Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate (PR) | Post-dose: Week0; n=82, 83 | -2.2 Beats per minute | Standard Deviation 7.2 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week1; n=79, 75 | 0.8 Beats per minute | Standard Deviation 6.12 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week2; n=73, 75 | 2.9 Beats per minute | Standard Deviation 7.31 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Pre-dose:Week4; n=49, 59 | -0.3 Beats per minute | Standard Deviation 9.73 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Post-dose:Week4; n=48, 59 | -2.0 Beats per minute | Standard Deviation 10 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week6; n=45, 57 | 3.3 Beats per minute | Standard Deviation 11.85 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Pre-dose: Week8; n=34, 47 | -0.3 Beats per minute | Standard Deviation 9.11 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Post-dose: Week8; n=34, 47 | -0.9 Beats per minute | Standard Deviation 10.39 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week10; n=34, 46 | 2.6 Beats per minute | Standard Deviation 8.86 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Pre-dose: Week12; n=24, 39 | 2.8 Beats per minute | Standard Deviation 8.04 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week16; n=24, 39 | 3.5 Beats per minute | Standard Deviation 9.14 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Post-dose: Week12; n=24, 39 | 0.9 Beats per minute | Standard Deviation 8.84 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week14; n=24, 39 | 3.1 Beats per minute | Standard Deviation 9.81 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week20; n=76, 78 | 2.1 Beats per minute | Standard Deviation 8.34 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week24; n=75, 76 | 2.3 Beats per minute | Standard Deviation 8 |
| Placebo | Change From Baseline in Pulse Rate (PR) | Week28; n=74, 77 | 2.5 Beats per minute | Standard Deviation 8.5 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week14; n=24, 39 | 3.6 Beats per minute | Standard Deviation 6.62 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Post-dose: Week0; n=82, 83 | -0.1 Beats per minute | Standard Deviation 6.54 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Post-dose:Week4; n=48, 59 | -1.0 Beats per minute | Standard Deviation 10.93 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week10; n=34, 46 | 2.4 Beats per minute | Standard Deviation 6.72 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week1; n=79, 75 | 3.1 Beats per minute | Standard Deviation 7.95 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week16; n=24, 39 | 2.6 Beats per minute | Standard Deviation 8.3 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week2; n=73, 75 | 1.7 Beats per minute | Standard Deviation 7.86 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Pre-dose: Week12; n=24, 39 | 1.7 Beats per minute | Standard Deviation 7.53 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Pre-dose:Week4; n=49, 59 | 0.1 Beats per minute | Standard Deviation 9.72 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week24; n=75, 76 | 2.5 Beats per minute | Standard Deviation 7.98 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week20; n=76, 78 | 3.6 Beats per minute | Standard Deviation 9.48 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week6; n=45, 57 | 2.8 Beats per minute | Standard Deviation 9.26 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Post-dose: Week12; n=24, 39 | -1.2 Beats per minute | Standard Deviation 10.57 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Pre-dose: Week8; n=34, 47 | 1.0 Beats per minute | Standard Deviation 7.62 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Week28; n=74, 77 | 2.3 Beats per minute | Standard Deviation 7.98 |
| GSK3772847 | Change From Baseline in Pulse Rate (PR) | Post-dose: Week8; n=34, 47 | -0.6 Beats per minute | Standard Deviation 9.71 |
Secondary
Change From Baseline in QRS Axis
Triplicate 12-lead ECGs were recorded with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in QRS Axis | Post-dose: Week0; n=80, 80 | -0.8 Degrees | Standard Deviation 10.76 |
| Placebo | Change From Baseline in QRS Axis | Pre-dose: Week4; n=49, 59 | 0.7 Degrees | Standard Deviation 14.3 |
| Placebo | Change From Baseline in QRS Axis | Post-dose: Week4; n=48, 59 | -0.1 Degrees | Standard Deviation 16.72 |
| Placebo | Change From Baseline in QRS Axis | Pre-dose: Week8; n=34, 47 | -0.2 Degrees | Standard Deviation 10.56 |
| Placebo | Change From Baseline in QRS Axis | Post-dose: Week8; n=33, 47 | 1.0 Degrees | Standard Deviation 9.88 |
| Placebo | Change From Baseline in QRS Axis | Pre-dose:Week12; n=24, 39 | 0.2 Degrees | Standard Deviation 8.59 |
| Placebo | Change From Baseline in QRS Axis | Post-dose Week12; n=24, 39 | -1.3 Degrees | Standard Deviation 9.49 |
| Placebo | Change From Baseline in QRS Axis | Week16; n=24, 39 | 2.3 Degrees | Standard Deviation 11.35 |
| GSK3772847 | Change From Baseline in QRS Axis | Week16; n=24, 39 | -1.4 Degrees | Standard Deviation 10.88 |
| GSK3772847 | Change From Baseline in QRS Axis | Post-dose: Week0; n=80, 80 | 1.9 Degrees | Standard Deviation 6.75 |
| GSK3772847 | Change From Baseline in QRS Axis | Post-dose: Week8; n=33, 47 | -1.2 Degrees | Standard Deviation 8.37 |
| GSK3772847 | Change From Baseline in QRS Axis | Pre-dose: Week4; n=49, 59 | 2.3 Degrees | Standard Deviation 13.77 |
| GSK3772847 | Change From Baseline in QRS Axis | Post-dose Week12; n=24, 39 | -1.2 Degrees | Standard Deviation 15.73 |
| GSK3772847 | Change From Baseline in QRS Axis | Post-dose: Week4; n=48, 59 | 1.4 Degrees | Standard Deviation 11.95 |
| GSK3772847 | Change From Baseline in QRS Axis | Pre-dose:Week12; n=24, 39 | 2.0 Degrees | Standard Deviation 31.39 |
| GSK3772847 | Change From Baseline in QRS Axis | Pre-dose: Week8; n=34, 47 | -1.0 Degrees | Standard Deviation 9.34 |
Secondary
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on Health-related quality of life (HRQoL) of participants with Chronic Obstructive Pulmonary Disease (COPD). It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 4, 8, 12 and 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week4; n=43, 52 | -10.0 Scores on a scale | Standard Deviation 14.98 |
| Placebo | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week8; n=31, 42 | -10.7 Scores on a scale | Standard Deviation 15.32 |
| Placebo | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week12; n=23, 35 | -15.8 Scores on a scale | Standard Deviation 21.42 |
| Placebo | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week16; n=16, 26 | -12.4 Scores on a scale | Standard Deviation 20.75 |
| GSK3772847 | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week16; n=16, 26 | -16.5 Scores on a scale | Standard Deviation 18.51 |
| GSK3772847 | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week4; n=43, 52 | -7.0 Scores on a scale | Standard Deviation 11.41 |
| GSK3772847 | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week12; n=23, 35 | -12.9 Scores on a scale | Standard Deviation 14.91 |
| GSK3772847 | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score | Week8; n=31, 42 | -7.2 Scores on a scale | Standard Deviation 17.08 |
Secondary
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
Using a Holter monitor, supraventricular couplets, supraventricular ectopics, supraventricular runs, supraventricular singles, ventricular couplets, ventricular ectopics, ventricular runs, ventricular singles were recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline and Weeks 0, 4 and 12
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular couplets: Week4; n=49, 58 | -1.9 Events per hour | Standard Deviation 14.11 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular runs: Week12; n=24, 37 | 0.0 Events per hour | Standard Deviation 0.29 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular singles: Week0; n=81, 80 | 44.0 Events per hour | Standard Deviation 228.09 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular singles: Week4; n=49, 58 | -10.4 Events per hour | Standard Deviation 104.12 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular singles: Week12; n=24, 37 | -5.4 Events per hour | Standard Deviation 53.23 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular couplets: Week0; n=81, 80 | -2.0 Events per hour | Standard Deviation 21.68 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular couplets: Week12; n=24, 37 | -3.9 Events per hour | Standard Deviation 35.82 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular ectopics: Week0; n=81, 80 | 2.6 Events per hour | Standard Deviation 369.71 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular ectopics: Week4; n=49, 58 | -30.9 Events per hour | Standard Deviation 445.93 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular ectopics: Week12; n=24, 37 | 34.9 Events per hour | Standard Deviation 300.07 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular runs: Week0; n=81, 80 | -0.5 Events per hour | Standard Deviation 3.62 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular runs: Week4; n=49, 58 | -0.1 Events per hour | Standard Deviation 2.37 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular runs: Week12; n=24, 37 | -1.1 Events per hour | Standard Deviation 6.3 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular singles: Week0; n=81, 80 | 9.0 Events per hour | Standard Deviation 349.81 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular singles: Week4; n=49, 58 | -25.3 Events per hour | Standard Deviation 425.2 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular singles: Week12; n=24, 37 | 45.5 Events per hour | Standard Deviation 263.03 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular couplets: Week0; n=81, 80 | 0.7 Events per hour | Standard Deviation 3.8 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular couplets: Week4; n=49, 58 | 0.2 Events per hour | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular couplets: Week12; n=24, 37 | 0.0 Events per hour | Standard Deviation 0 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular ectopics: Week0; n=81, 80 | 44.6 Events per hour | Standard Deviation 265.28 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular ectopics: Week4; n=49, 58 | -10.7 Events per hour | Standard Deviation 105.24 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular ectopics: Week12; n=24, 37 | -5.3 Events per hour | Standard Deviation 52.78 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular runs: Week0; n=81, 80 | 0.0 Events per hour | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular runs: Week4; n=49, 58 | 0.0 Events per hour | Standard Deviation 0.29 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular runs: Week4; n=49, 58 | -0.6 Events per hour | Standard Deviation 3.01 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular runs: Week4; n=49, 58 | 0.0 Events per hour | Standard Deviation 0 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular couplets: Week4; n=49, 58 | 0.1 Events per hour | Standard Deviation 0.65 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular runs: Week12; n=24, 37 | 0.0 Events per hour | Standard Deviation 0 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular runs: Week12; n=24, 37 | -0.4 Events per hour | Standard Deviation 1.83 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular singles: Week0; n=81, 80 | -12.2 Events per hour | Standard Deviation 139.28 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular ectopics: Week4; n=49, 58 | 6.4 Events per hour | Standard Deviation 54.8 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular singles: Week4; n=49, 58 | 6.3 Events per hour | Standard Deviation 53.79 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular singles: Week0; n=81, 80 | -13.1 Events per hour | Standard Deviation 120.73 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular singles: Week12; n=24, 37 | 174.5 Events per hour | Standard Deviation 921.42 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular couplets: Week12; n=24, 37 | 0.3 Events per hour | Standard Deviation 1.43 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular couplets: Week0; n=81, 80 | 16.5 Events per hour | Standard Deviation 144.04 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular ectopics: Week0; n=81, 80 | 6.8 Events per hour | Standard Deviation 188.46 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular couplets: Week4; n=49, 58 | -2.2 Events per hour | Standard Deviation 9.86 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular singles: Week4; n=49, 58 | -3.1 Events per hour | Standard Deviation 138.3 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular couplets: Week12; n=24, 37 | -0.5 Events per hour | Standard Deviation 3.48 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular runs: Week0; n=81, 80 | 0.0 Events per hour | Standard Deviation 0.19 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular singles: Week12; n=24, 37 | 8.4 Events per hour | Standard Deviation 89.64 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular ectopics: Week4; n=49, 58 | -7.3 Events per hour | Standard Deviation 148.2 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular ectopics: Week0; n=81, 80 | -12.2 Events per hour | Standard Deviation 141.39 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular ectopics: Week12; n=24, 37 | 9.4 Events per hour | Standard Deviation 94.82 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular couplets: Week0; n=81, 80 | -0.1 Events per hour | Standard Deviation 1.59 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | supraventricular runs: Week0; n=81, 80 | 0.2 Events per hour | Standard Deviation 2.09 |
| GSK3772847 | Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles | ventricular ectopics: Week12; n=24, 37 | 176.0 Events per hour | Standard Deviation 926.75 |
Secondary
Number of Hospitalizations or Emergency Room Visits Per Participants
The number of hospitalization or emergency room visit made by per participant due to loss of asthma control have been presented in category titles. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Hospitalizations or Emergency Room Visits Per Participants | 0 | 77 Participants |
| Placebo | Number of Hospitalizations or Emergency Room Visits Per Participants | 1 | 1 Participants |
| Placebo | Number of Hospitalizations or Emergency Room Visits Per Participants | 2 | 0 Participants |
| Placebo | Number of Hospitalizations or Emergency Room Visits Per Participants | >=3 | 0 Participants |
| GSK3772847 | Number of Hospitalizations or Emergency Room Visits Per Participants | >=3 | 0 Participants |
| GSK3772847 | Number of Hospitalizations or Emergency Room Visits Per Participants | 0 | 78 Participants |
| GSK3772847 | Number of Hospitalizations or Emergency Room Visits Per Participants | 2 | 0 Participants |
| GSK3772847 | Number of Hospitalizations or Emergency Room Visits Per Participants | 1 | 0 Participants |
Secondary
Number of Participants Experiencing Asthma Related Hospitalization During the Study Period
Hospitalization is defined as an inpatient stay or least an overnight stay at the hospital or emergency ward for observation or other equivalent facility. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat (mITT) population consisted of all randomized participants who took at least 1 dose of study treatment and were analyzed according to the treatment they received \>=50% of the time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Experiencing Asthma Related Hospitalization During the Study Period | 1 Participants |
| GSK3772847 | Number of Participants Experiencing Asthma Related Hospitalization During the Study Period | 0 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
A non-SAE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment were categorized as SAE.
Time frame: Up to Week 16
Population: Safety Population consists of all randomized participants who took at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) | non-SAE | 20 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) | SAE | 1 Participants |
| GSK3772847 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) | non-SAE | 19 Participants |
| GSK3772847 | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) | SAE | 2 Participants |
Secondary
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Blood samples were collected at given time points and the presence of anti-GSK3772847 antibodies were assessed using a a tiered approach including a screening assay, a confirmation assay and calculation of titer. Data for participants who showed positive results for confirmation assay has been presented
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and 28
Population: Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week2; n=73, 74 | 0 Participants |
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week4; n=49, 59 | 0 Participants |
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week8; n=34, 47 | 0 Participants |
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week12; n=24, 39 | 0 Participants |
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week16; n=23, 39 | 0 Participants |
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week20; n=73, 75 | 1 Participants |
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week24; n=74, 75 | 0 Participants |
| Placebo | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week28; n=74, 74 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week28; n=74, 74 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week2; n=73, 74 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week16; n=23, 39 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week4; n=49, 59 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week24; n=74, 75 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week8; n=34, 47 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week20; n=73, 75 | 0 Participants |
| GSK3772847 | Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies | Week12; n=24, 39 | 0 Participants |
Secondary
Percentage of Participants Who Have Pre-bronchodilator FEV1 Decrease From Baseline >7.5 %
Pulmonary function is measured by FEV1. FEV1 is the amount of air expired in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. Baseline is defined as the latest available pre-dose assessment (Day 1). Decrease from Baseline \>7.5 % in score suggests worsening of condition.
Time frame: Baseline and up to Week 16
Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Have Pre-bronchodilator FEV1 Decrease From Baseline >7.5 % | 63 Percentage of participants |
| GSK3772847 | Percentage of Participants Who Have Pre-bronchodilator FEV1 Decrease From Baseline >7.5 % | 68 Percentage of participants |
Secondary
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath & wheeze) enquire about the frequency &/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A responder is defined as participants with change from Baseline of \<= -0.5 point at given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week4; n=54, 59 | 59 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week9; n=30, 42 | 70 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week5; n= 42, 52 | 62 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week10; n=29, 41 | 69 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week1; n=72, 73 | 38 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week6; n=40, 48 | 63 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week12; n=23, 38 | 57 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week3; n=61, 61 | 49 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week13; n=17,32 | 82 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week7; n=34, 46 | 74 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week14; n=17, 31 | 71 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week2; n=67, 68 | 46 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week15; n=17, 27 | 76 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week8; n=33, 44 | 70 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week16; n=12, 21 | 67 Percentage of participants |
| Placebo | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week11; n=22, 38 | 64 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week16; n=12, 21 | 81 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week1; n=72, 73 | 41 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week2; n=67, 68 | 56 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week3; n=61, 61 | 56 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week4; n=54, 59 | 61 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week5; n= 42, 52 | 65 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week6; n=40, 48 | 69 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week7; n=34, 46 | 65 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week8; n=33, 44 | 73 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week9; n=30, 42 | 71 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week10; n=29, 41 | 76 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week11; n=22, 38 | 79 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week12; n=23, 38 | 79 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week13; n=17,32 | 75 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week14; n=17, 31 | 74 Percentage of participants |
| GSK3772847 | Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder) | Week15; n=17, 27 | 74 Percentage of participants |
Secondary
Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline
The ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A change of \>=0.5 in score suggests a clinically important change in score. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment
Time frame: Baseline and up to Week 16
Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline | 39 Percentage of participants |
| GSK3772847 | Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline | 30 Percentage of participants |
Secondary
Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ)
SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). A responder is defined as a change from Baseline of \<= -4 at the given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 4, 8, 12 and 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week4; n=43, 52 | 60 Percentage of participants |
| Placebo | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week8; n=31, 42 | 61 Percentage of participants |
| Placebo | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week12; n=23, 35 | 70 Percentage of participants |
| Placebo | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week16; n=16, 26 | 69 Percentage of participants |
| GSK3772847 | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week16; n=16, 26 | 88 Percentage of participants |
| GSK3772847 | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week4; n=43, 52 | 58 Percentage of participants |
| GSK3772847 | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week12; n=23, 35 | 74 Percentage of participants |
| GSK3772847 | Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ) | Week8; n=31, 42 | 67 Percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Asthma Exacerbation
A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Clinically Significant Asthma Exacerbation | 7 Percentage of participants |
| GSK3772847 | Percentage of Participants With Clinically Significant Asthma Exacerbation | 13 Percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Asthma Exacerbation or Inability to Titrate
A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization. Participants with clinically significant asthma exacerbation or inability to titrate FP indicated loss of asthma control.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Clinically Significant Asthma Exacerbation or Inability to Titrate | 25 Percentage of participants |
| GSK3772847 | Percentage of Participants With Clinically Significant Asthma Exacerbation or Inability to Titrate | 40 Percentage of participants |
Secondary
Percentage of Participants With Inability to Titrate Inhaled Corticosteroids (ICS)
Corticosteroid titration allows overall clinical evaluation of the participant's asthma status taking into account both lung function and symptom control. Inability to titrate inhaled corticosteroids indicates loss of asthma control.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Inability to Titrate Inhaled Corticosteroids (ICS) | 23 Percentage of participants |
| GSK3772847 | Percentage of Participants With Inability to Titrate Inhaled Corticosteroids (ICS) | 30 Percentage of participants |
Secondary
Percentage of Participants With Loss of Asthma Control Over Weeks 0-6
Loss of asthma control is defined as: ACQ-5 score increase from Baseline \>=0.5 point or pre-bronchodilator FEV1 decrease from Baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral OCS and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 6 has been presented.
Time frame: Up to Week 6
Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Loss of Asthma Control Over Weeks 0-6 | 50 Percentage of participants |
| GSK3772847 | Percentage of Participants With Loss of Asthma Control Over Weeks 0-6 | 36 Percentage of participants |
95% CI: [0.44, 1.01]
Secondary
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
FeNO was assessed as a measure of airway inflammation using a handheld electronic device. The measurements recorded were according to standardized procedures by the American Thoracic Society and the European Respiratory Society Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide. FeNO measurements were obtained prior to FEV1 assessments. Participants did not use their rescue medication for at least 6 hours before each FeNO assessment, unless essential for clinical need. Baseline is defined as the latest available assessment prior to first dose (Day 1). Percent change from Baseline is calculated as ratio to Baseline minus one and multiplied by 100. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14 and 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week14; n=19, 30 | 28.1 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week1; n=60, 63 | -3.6 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week2; n=58, 59 | 15.4 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week4; n=41, 50 | 15.2 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week6; n=34, 46 | 5.0 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week8; n=29, 38 | 15.9 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week10; n=29, 37 | 13.8 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week12; n=19, 31 | 31.4 Percent Change |
| Placebo | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week16; n=13, 22 | 85.9 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week12; n=19, 31 | 8.8 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week8; n=29, 38 | -2.9 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week1; n=60, 63 | -4.9 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week14; n=19, 30 | 1.7 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week2; n=58, 59 | 0.0 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week10; n=29, 37 | 0.0 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week4; n=41, 50 | 3.3 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week16; n=13, 22 | 12.7 Percent Change |
| GSK3772847 | Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Week6; n=34, 46 | 0.0 Percent Change |
Secondary
Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Blood samples were collected at given time points to measure free soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100.
Time frame: Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week4; Pre-dose; n=48, 56 | -5.6 Percent change |
| Placebo | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week8; Pre-dose; n=33, 45 | -8.5 Percent change |
| Placebo | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week12; Pre-dose; n=23, 37 | 10.5 Percent change |
| Placebo | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week16; n=16, 26 | 19.8 Percent change |
| GSK3772847 | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week16; n=16, 26 | -92.0 Percent change |
| GSK3772847 | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week4; Pre-dose; n=48, 56 | -93.8 Percent change |
| GSK3772847 | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week12; Pre-dose; n=23, 37 | -92.5 Percent change |
| GSK3772847 | Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | Week8; Pre-dose; n=33, 45 | -93.5 Percent change |
p-value: <0.00195% CI: [-94.9, -91.7]mixed model repeated measures analysis
p-value: <0.00195% CI: [-94.8, -90.3]mixed model repeated measures analysis
p-value: <0.00195% CI: [-95.4, -90]mixed model repeated measures analysis
p-value: <0.00195% CI: [-95.3, -90.4]mixed model repeated measures analysis
Secondary
Percent Change From Baseline in Total Soluble ST2 Concentration
Blood samples were collected at given time points to measure total soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100.
Time frame: Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16
Population: Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Soluble ST2 Concentration | Week12; Pre-dose; n=23, 37 | -13.4 Percent change |
| Placebo | Percent Change From Baseline in Total Soluble ST2 Concentration | Week8; Pre-dose; n=33, 45 | -6.9 Percent change |
| Placebo | Percent Change From Baseline in Total Soluble ST2 Concentration | Week16; n=16, 26 | -12.0 Percent change |
| Placebo | Percent Change From Baseline in Total Soluble ST2 Concentration | Week4; Pre-dose; n=48, 56 | 16.3 Percent change |
| GSK3772847 | Percent Change From Baseline in Total Soluble ST2 Concentration | Week16; n=16, 26 | 2330.8 Percent change |
| GSK3772847 | Percent Change From Baseline in Total Soluble ST2 Concentration | Week8; Pre-dose; n=33, 45 | 2326.9 Percent change |
| GSK3772847 | Percent Change From Baseline in Total Soluble ST2 Concentration | Week12; Pre-dose; n=23, 37 | 1858.0 Percent change |
| GSK3772847 | Percent Change From Baseline in Total Soluble ST2 Concentration | Week4; Pre-dose; n=48, 56 | 2691.1 Percent change |
p-value: <0.00195% CI: [1833.9, 2879.3]mixed model repeated measures analysis
p-value: <0.00195% CI: [1924.2, 3259.4]mixed model repeated measures analysis
p-value: <0.00195% CI: [1489.1, 3120.3]mixed model repeated measures analysis
p-value: <0.00195% CI: [1994.6, 3544.8]mixed model repeated measures analysis
Secondary
Rate Per 1000 Person-years of Participants With Hospitalization
An event is defined as an on-treatment asthma-related hospitalization or emergency room visit and participants can contribute to more than one event. Rate is calculated as number of events \* 1000 divided by (number of participants in treatment group \* mean treatment exposure in years). Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Rate Per 1000 Person-years of Participants With Hospitalization | 70.5 Events per person-year |
| GSK3772847 | Rate Per 1000 Person-years of Participants With Hospitalization | 0 Events per person-year |
Secondary
Serum Concentrations of GSK3772847
Blood samples were collected at given time points to evaluate pharmacokinetics (PK) of GSK3772847 in participants with moderately severe asthma.
Time frame: Weeks 2, 4 (Pre-dose), 8 (Pre-dose), 12 (Pre-dose and Post-dose), 16, 20, 24 and 28
Population: PK Population consists of all randomized participants who received at least one dose of study medication, and for whom at least one pharmacokinetic sample was obtained, analyzed and was measurable. Participants with data available at specified time points were represented by n=x in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentrations of GSK3772847 | Week12; Post-dose; n=39 | 224.21 Micrograms per milliliter | Standard Deviation 151.78 |
| Placebo | Serum Concentrations of GSK3772847 | Week2; n=75 | 78.40 Micrograms per milliliter | Standard Deviation 30.934 |
| Placebo | Serum Concentrations of GSK3772847 | Week4; Pre-dose;n=59 | 44.42 Micrograms per milliliter | Standard Deviation 21.774 |
| Placebo | Serum Concentrations of GSK3772847 | Week8; Pre-dose; n= 47 | 61.44 Micrograms per milliliter | Standard Deviation 30.978 |
| Placebo | Serum Concentrations of GSK3772847 | Week12; Pre-dose; n=39 | 63.42 Micrograms per milliliter | Standard Deviation 34.42 |
| Placebo | Serum Concentrations of GSK3772847 | Week16; n=38 | 63.03 Micrograms per milliliter | Standard Deviation 36.328 |
| Placebo | Serum Concentrations of GSK3772847 | Week20; n=75 | 25.75 Micrograms per milliliter | Standard Deviation 19.074 |
| Placebo | Serum Concentrations of GSK3772847 | Week24; n=75 | 12.91 Micrograms per milliliter | Standard Deviation 16.061 |
| Placebo | Serum Concentrations of GSK3772847 | Week28; n=75 | 6.14 Micrograms per milliliter | Standard Deviation 16.005 |
Secondary
Time to Loss of Asthma Control
Time to loss of asthma control was analyzed using Kaplan-Meier analysis. In this analysis, participants were either be counted as an event or they were censored. An event is defined as participants who experience loss of asthma control during the study. Censoring is defined as participants who discontinued investigational product for reasons other than loss of asthma control. The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Participants who didn't experience loss of asthma control were also censored at day 113.
Time frame: Up to Week 16
Population: Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Loss of Asthma Control | 50 Days |
| GSK3772847 | Time to Loss of Asthma Control | 96 Days |
p-value: 0.044Log Rank