Dose Finding Study of Nemiralisib (GSK2269557) in Subject... | NCT03345407 | Trialant
NCT03345407
Sponsor
GlaxoSmithKline
Status
Terminated
Last Update Posted
Jul 14, 2021Actual
Enrollment
943Actual
Phase
Phase 2
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Placebo ELLIPTA
Nemiralisib ELLIPTA 50 µg
Nemiralisib ELLIPTA 100 µg
Nemiralisib ELLIPTA 250 µg
Nemiralisib ELLIPTA 500 µg
Nemiralisib ELLIPTA 750 µg
Albuterol (Salbutamol) MDI or nebules
Standard of care therapy
Countries
United States
Argentina
Australia
Canada
France
Germany
Italy
Mexico
Netherlands
Poland
Romania
Russia
South Korea
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03345407
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
200879
Secondary IDs
ID
Type
Description
Link
2017-001074-42
EudraCT Number
Brief Title
Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jul 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Unfavourable benefit:risk
Expanded Access Info
No
Start Date
Nov 28, 2017Actual
Primary Completion Date
Jan 10, 2019Actual
Completion Date
Jan 10, 2019Actual
First Submitted Date
Nov 14, 2017
First Submission Date that Met QC Criteria
Nov 14, 2017
First Posted Date
Nov 17, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 2, 2019
Results First Submitted that Met QC Criteria
Jan 15, 2020
Results First Posted Date
Feb 10, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 13, 2021
Last Update Posted Date
Jul 14, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses [up to 750 micrograms (µg)] compared with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in this double-blind study. Subjects will be randomized to receive different doses of nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Detailed Description
Not provided
Conditions Module
Conditions
Pulmonary Disease, Chronic Obstructive
Keywords
Nemiralisib
Dose-Finding
GSK2269557
Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
943Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
placebo once daily
Placebo Comparator
Eligible subjects will receive placebo ELLIPTA dry powder (blended with lactose) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.
Drug: Placebo ELLIPTA
Drug: Albuterol (Salbutamol) MDI or nebules
Drug: Standard of care therapy
Nemiralisib 50 µg once daily
Experimental
Eligible subjects will receive nemiralisib ELLIPTA 50 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.
Drug: Nemiralisib ELLIPTA 50 µg
Drug: Albuterol (Salbutamol) MDI or nebules
Drug: Standard of care therapy
Nemiralisib 100 µg once daily
Experimental
Eligible subjects will receive nemiralisib ELLIPTA 100 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.
Drug: Nemiralisib ELLIPTA 100 µg
Drug: Albuterol (Salbutamol) MDI or nebules
Drug: Standard of care therapy
Nemiralisib 250 µg once daily
Experimental
Eligible subjects will receive nemiralisib ELLIPTA 250 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo ELLIPTA
Drug
Placebo will be administered via oral inhalation route once daily in the morning.
placebo once daily
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 84 Measured Post Bronchodilator
FEV1 is maximal amount of air exhaled forcefully from lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered 4 inhalations of albuterol (salbutamol) via MDI using spacer/valved-holding chamber or via one nebulized treatment. Post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and post-bronchodilator. Change from Baseline in clinic visit trough FEV1 at Day 84 measured post-bronchodilator is FEV1 measured prior to dosing and post-bronchodilator on Day 84 minus post-bronchodilator Baseline FEV1. Bayesian repeated measure model adjusted for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender was used. Posterior adjusted median change from Baseline and 95% highest posterior density (HPD) credible interval (CrI) was presented.
Baseline and Day 84
Secondary Outcomes
Measure
Description
Time Frame
Rate of Moderate and Severe Exacerbations Over 12-week Treatment Period
Moderate COPD exacerbations are defined as worsening symptoms of COPD treated with short-acting bronchodilators (SABDs) plus antibiotics and/or oral/systemic corticosteroids. Severe COPD exacerbations are defined as worsening symptoms of COPD that require hospitalization or visit to the emergency room. Severe exacerbation may also be associated with acute respiratory failure. Rate of exacerbations was analyzed using Bayesian Poisson model adjusting for length of on-treatment follow-up, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Posterior median exacerbation rate and 95% HPD CrI has been presented.
Other Outcomes
Measure
Description
Time Frame
Area Under the Concentration Time Curve (AUC) From Time Zero to 24 Hours [AUC(0-24)] of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
AUC From Time Zero to Time 't' [AUC(0-t)] of Nemiralisib
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
40 to 80 years of age, inclusive, at Screening (Visit 1).
An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [ global initiative for chronic obstructive lung disease (GOLD), 2017] as follows: "Chronic obstructive pulmonary disease is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases."
Current or former cigarette smoker with a history of cigarette smoking of >=10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (Visit 1). Number of pack years = (number of cigarettes per day / 20) x number of years smoked).
Acute exacerbation of COPD requiring an escalation in therapy to include oral/systemic corticosteroid(s) (prednisone 40 mg/day or equivalent) for 5 days and antibiotic(s) for 7 days; the dose and/or duration of prednisone (40 mg/day or equivalent) and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice. Acute exacerbation to be confirmed by an experienced physician and to represent a recent worsening of at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms. Major symptoms include subjective increase in dyspnea, increase in sputum volume or change in sputum color. Minor symptoms include increased cough, increased wheeze, sore throat, colds or fever (oral temperature >37.5 degree Celsius) without other cause.
Body weight >=45 kilogram (kg) and body mass index (BMI) within the range 16 - 35 kg per meter square (kg/m^2) (inclusive)
Male and female subjects are eligible to participate in the study. 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 the contraceptive guidance during the 12-Week Double-Blind Treatment Period and for at least 5 half-lives (10 days) after the last of double-blind study treatment.
Capable of giving signed informed consent.
Exclusion Criteria:
Current diagnosis of asthma, according to the Global Initiative for Asthma (GINA, 2017). Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
Potential of hydrogen (pH) < 7.30 or the need for invasive mechanical ventilation.
Moderate/severe exacerbation of COPD for which SoC was started >48 hours since diagnosis.
A chest X-ray [or computed tomography (CT) scan] that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray (or CT scan) must be taken at Screening (Visit 1). For sites in Germany: if a chest X-ray (or CT scan) within 1 year of Screening (Visit 1) is not available, approval to conduct a diagnostic chest X-ray (CT scan) will need to be obtained from the Federal Office for Radiation Protection (BfS).
Clinically significant pneumonia, identified by chest X-ray (CT scan) at Screening.
A diagnosis of alpha 1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, clinically overt bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), primary pulmonary hypertension, interstitial lung diseases,or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results.
A history or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., subjects requiring implanted cardioverter defibrillator [ICD], pacemaker requiring a rate set >60 beats per minute (bpm), uncontrolled hypertension, New Your Heart Association Class IV [NYHA, 1994], known left ventricular ejection fraction <30 percent) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or hematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. (Note: subjects with adequately treated and well controlled concurrent medical conditions (e.g. hypertension or noninsulin-dependent diabetes mellitus [NIDDM]) are permitted to be entered into the study).
Having undergone lung volume reduction surgery or lung resection for any other reason e.g. lung carcinoma
Liver diseases including ALT>2x upper limit of normal (ULN); Total bilirubin >1.5xULN (Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to first dose of study treatment; Positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study treatment.
Positive hepatitis C ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
Carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin are not excluded if the subject has been considered cured within 5 years since diagnosis.
History of allergy or hypersensitivity to any of the study medications [e.g. beta-agonists, Phosphoinositide 3-Kinase Delta (PI3Kd) inhibitors] or components of the inhalation powder (e.g., lactose). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation are excluded.
Strong inhibitors of cytochrome P450 3A4 (CYP3A4) including antiretrovirals including protease inhibitors; Oral antifungal treatments such as ketoconazole and itraconazole. It is recommended that posaconazole is used as the oral antifungal treatment of choice. Short courses of up to 14 days are allowed for fluconazole and voriconazole, but chronic administrations are not permitted; Antibiotics such as telithromycin and troleandomycin (macrolide). It is recommended that azithromycin is used as the macrolide antibiotic of choice. Short courses up to 14 days are allowed for mibefradil (calcium channel blocker), erythromycin and clarithromycin (including intravenous clarithromycin) but chronic administrations are not permitted; Anti-epileptic treatments; and anti-tuberculosis therapy. These medications must all have been stopped at least 14 days prior to first dose of study treatment. Use of sensitive narrow therapeutic index CYP3A4 substrates including alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus; Intravenous theophylline will be allowed but only under strict therapeutic drug monitoring for signs of theophylline toxicity as a result of co-administration with nemiralisib; Subjects may be recruited into the study already under treatment with theophylline or started on theophylline following the start of treatment and before the end of 14 days post last dose.
Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for >15 hours a day. Oxygen prn use (<=15 hours per day) is not exclusionary. Oxygen use during an exacerbation is permitted.
Chronic treatment with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), or any other immunosuppressive therapy within 60 days prior to the first dose of double-blind study treatment.
Clinically significant sleep apnea that requires the use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) for > 48 hours.
Any other investigational treatment within the following time periods prior to the first dose of double-blind study treatment in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer. Note: subjects who participated in a previously completed study and/or were withdrawn from an ongoing study that included/includes nemiralisib are excluded from participating in this study.
Exposure to more than 4 investigational medicinal products within 12 months prior to the first dose of double-blind study treatment in the current study.
A clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the exclusion criteria, outside of the reference range for the population being studied may be included if the Investigator [in consultation with the GlaxoSmithKline (GSK) Medical Monitor if required] documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Abnormal, clinically significant ECG finding (e.g. myocardial Infarction or demonstrating a clinically significant arrhythmia requiring treatment) at Screening (Visit 1) or upon repeat prior to randomization.
QT interval corrected for heart rate according to Fridericia's formula (QTcF) >480 milliseconds (msec) for subjects with or without Bundle Branch Block, based on single QTcF value.
A positive test for human immunodeficiency virus (HIV) antibody at Screening.
Known or suspected history of alcohol or drug abuse within the last 2 years.
History of regular alcohol consumption defined as an average weekly intake of >28 units for males or >21 units for females within 6 months of Screening (Visit 1). One unit is equivalent to 8 grams of alcohol: a half-pint [approximately 240 milliliter (mL)] of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
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.
Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
Fahy WA, Homayoun-Valiani F, Cahn A, Robertson J, Templeton A, Meeraus WH, Wilson R, Lowings M, Marotti M, West SL, Tabberer M, Hessel EM. Nemiralisib in Patients with an Acute Exacerbation of COPD: Placebo-Controlled, Dose-Ranging Study. Int J Chron Obstruct Pulmon Dis. 2021 Jun 3;16:1637-1646. doi: 10.2147/COPD.S309320. eCollection 2021.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study is available via the Clinical Study Data Request site
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 943 participants were randomized, and 938 participants who received at least one dose of study treatment were included in the modified intent to treat (MITT) Population. The study included participants enrolled from 16 countries.
Recruitment Details
This was a Phase IIb, multicenter, randomized, stratified, double-blind (sponsor open), placebo controlled parallel-group study in participants who presented with an acute moderate or severe exacerbation of chronic obstructive pulmonary disease (COPD) requiring Standard of Care (SoC).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
FG001
Nemiralisib 12.5 mcg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 14, 2017
Nov 26, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects will be randomized to receive either nemiralisib (50-750 µg) or placebo in a parallel group.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
This will be a double blind, sponsor- open study.
Who Masked
ParticipantInvestigator
Drug: Nemiralisib ELLIPTA 250 µg
Drug: Albuterol (Salbutamol) MDI or nebules
Drug: Standard of care therapy
Nemiralisib 500 µg once daily
Experimental
Eligible subjects will receive nemiralisib ELLIPTA 500 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.
Drug: Nemiralisib ELLIPTA 500 µg
Drug: Albuterol (Salbutamol) MDI or nebules
Drug: Standard of care therapy
Nemiralisib 750 µg once daily
Experimental
Eligible subjects will receive nemiralisib ELLIPTA 750 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.
Drug: Nemiralisib ELLIPTA 750 µg
Drug: Albuterol (Salbutamol) MDI or nebules
Drug: Standard of care therapy
Nemiralisib ELLIPTA 50 µg
Drug
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 50 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib 50 µg once daily
Nemiralisib ELLIPTA 100 µg
Drug
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 100 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib 100 µg once daily
Nemiralisib ELLIPTA 250 µg
Drug
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 250 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib 250 µg once daily
Nemiralisib ELLIPTA 500 µg
Drug
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 500 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib 500 µg once daily
Nemiralisib ELLIPTA 750 µg
Drug
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 750 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib 750 µg once daily
Albuterol (Salbutamol) MDI or nebules
Drug
Albuterol (Salbutamol) MDI or nebules will be provided to all subjects as a rescue medication.
Nemiralisib 100 µg once daily
Nemiralisib 250 µg once daily
Nemiralisib 50 µg once daily
Nemiralisib 500 µg once daily
Nemiralisib 750 µg once daily
placebo once daily
Standard of care therapy
Drug
SoC therapy for the index exacerbation is defined as treatment with oral/systemic corticosteroid (prednisone 40 mg/day or equivalent) for 5 days and antibiotic for 7 days. Subjects will receive SoC as prescribed by the Investigator or medically qualified designee. The dose and/or duration of prednisone and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice.
Nemiralisib 100 µg once daily
Nemiralisib 250 µg once daily
Nemiralisib 50 µg once daily
Nemiralisib 500 µg once daily
Nemiralisib 750 µg once daily
placebo once daily
Up to Week 12
Number of Participants With Time to Next Moderate/Severe Exacerbation Following Index Exacerbation
Number of participants with time to next (on-treatment) moderate/severe exacerbation following index exacerbation during the 12-Week Treatment Period was defined as time from the date of randomization until the date of onset of the first moderate/severe exacerbation whilst on study treatment. Participants who did not have an exacerbation whilst on study treatment were censored at the date of their last dose of study treatment. Time to next exacerbation was analyzed using a Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.
Up to Week 12
Change From Baseline in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator
Pulmonary function was measured by FEV1, defined as maximal amount of air exhaled forcefully from the lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered with 4 inhalations of albuterol via MDI using a spacer/valved-holding chamber or via 1 nebulized treatment. Pre-bronchodilator and post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and pre-bronchodilator and post-bronchodilator, respectively. Change from Baseline in clinic visit trough FEV1 at Days 14, 28, 56 and 84 measured pre-bronchodilator is defined as FEV1 measured prior to dosing and pre-bronchodilator on Days 14, 28, 56 and 84 minus pre-bronchodilator Baseline FEV1.
Baseline and Days 14, 28, 56 (pre and post bronchodilaor), 84 (pre-bronchodilator) and at hospital discharge (maximum 24 Weeks)
Change From Hospital Discharge in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator
Pulmonary function was measured by FEV1, defined as maximal amount of air exhaled forcefully from the lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10 to 30 minutes after participant was administered with 4 inhalations of albuterol via MDI using a spacer/valved-holding chamber or via 1 nebulized treatment. Pre-bronchodilator and post-bronchodilator Baseline FEV1 is defined as latest FEV1 measured prior to first dose of study treatment and pre-bronchodilator and post-bronchodilator, respectively. Change from hospital discharge in clinic visit trough FEV1 at Days 14, 28, 56 and 84 measured pre- and post-bronchodilator is defined as FEV1 measured prior to dosing and pre- and post-bronchodilator on Days 14, 28, 56 and 84 minus pre and post-bronchodilator Baseline FEV1.
Baseline and pre- and post-bronchodilator on Days 14, 28, 56 and 84
Percentage of Participants Achieving the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Definition of Recovery From the Index Exacerbation
EXACT patient-reported outcome (EXACT-PRO), 14-item instrument to capture occurrence, frequency, severity, and duration of exacerbations using an electronic diary (eDiary). Total score ranges from 0-100, higher score indicates more severe condition. Participants were required to complete EXACT-PRO every evening; however, on the day of randomization it was to be completed in the morning. Response was decrease in rolling average EXACT Total Score >=9 points from maximum observed value, sustained for >=7 days, with first of 7 days defined as recovery day. Analysis was performed using Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender.
Days 14, 28, 56 and 84
Number of Participants With Time to Recovery From Index Exacerbation Using EXACT- PRO Tool
Time to EXACT-defined recovery from index exacerbation is defined as time from the date of randomization until date of the first EXACT-defined recovery day during the 12-Week Treatment Period. EXACT-defined recovery from the index exacerbation is defined as a decrease in the Rolling Average EXACT total Score >=9 points from the Maximum Observed Value, sustained for >=7 days, with the first of the 7 days defined as the recovery day. Analysis was performed using a Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Number of participants reporting events is presented.
From randomization to Week 12
Mean Severity of Subsequent Health Care Resource Use (HCRU) Exacerbations Defined by EXACT
Severity of subsequent HCRU-defined exacerbations defined by EXACT was defined as the highest EXACT Total Score (not using the 3-day Rolling Average) during the period from date of onset of the subsequent HCRU-exacerbation until date of EXACT-defined recovery of subsequent exacerbation. EXACT-PRO, 14-item instrument to capture occurrence, frequency, severity, and duration of exacerbations using an eDiary. Total score ranges from 0-100, higher score indicates more severe condition. For participants with more than one subsequent exacerbation, severity was calculated for each subsequent exacerbation.
Up to Week 12
Percentage of Responders Using the COPD Assessment Test (CAT) on Treatment Days 28, 56, and 84, and Following EXACT Defined Recovery From the Index Exacerbation
The CAT is a short, self-completed, 8-item questionnaire, each item was rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating severe condition. The percentage of responders using the CAT is defined as number of participants with a decrease from Baseline in CAT Total Score >=2 on or before Days 28, 56 and 84 divided by total number of participants in the MITT population. Percentage of responders using CAT was derived only for participants with a Baseline CAT Total Score >=2. Analysis was performed using a separate Bayesian logistic regression for each time point adjusting for treatment group, smoking status at baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.
Days 28, 56 and 84
Change From Baseline in CAT Total Score
The CAT is a short, self-completed, 8-item questionnaire, each item was rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score was calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating more severe condition. Baseline (Day 1) is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in CAT Total Score is defined as CAT Total Score on Days 28, 56 and 84 minus Baseline CAT Total Score. Analysis was performed using Bayesian repeated measures model adjusting for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Posterior adjusted median change from Baseline and 95% HPD CrI has been presented.
Baseline and at Days 28, 56 and 84
Percentage of Responders on the St. George's Respiratory Questionnaire (SGRQ) Total Score as Measured by the SGRQ for COPD Participants (SGRQ-C) at Days 28, 56, and 84
SGRQ-C is a 40-item questionnaire designed specifically to focus on COPD participants and was scored equivalent to the SGRQ Total Score, ranging from 0 to 100, where higher scores reflect worse health-related quality of life. The percentage of responders on the SGRQ Total Score was derived for participants with a Baseline SGRQ Total Score >=4. Percentage of responders on the SGRQ Total Score is defined as number of participants with a decrease from Baseline in SGRQ Total Score >=4 on or before Days 28, 56 and 84 divided by total number of participants in the MITT population. Analysis was performed using a separate Bayesian logistic regression for each time point adjusting for treatment group, smoking status at baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.
Days 28, 56 and 84
Change From Baseline in SGRQ Total Score at Days 28, 56 and 84
SGRQ-C is a 40-item questionnaire designed specifically to focus on COPD participants and was scored equivalent to SGRQ Total Score, ranging from 0 to 100, where higher scores reflect worse health-related quality of life. Scores on a scale were calculated as 100 multiplied by summed weights from positive items in questionnaire divided by sum of weights of all items in questionnaire. Baseline (Day 1) is defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in SGRQ Total Score is defined as SGRQ Total Score on Days 28, 56 and 84 minus Baseline SGRQ Total Score. Analysis was performed using Bayesian repeated measures model adjusting for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender. Posterior adjusted median change from Baseline and 95% HPD CrI was presented
Baseline and Days 28, 56 and 84
Mean Number of Occasions of Rescue Medication Use Per Day
Albuterol (Salbutamol) MDI or nebules was used as a rescue medication. Rescue medication use was recorded as the number of occasions of rescue medication use each day. The mean number of occasions of rescue medication use per day is defined as sum of the number of occasions of rescue medication use each day within the time-period divided by the total number of days with non-missing values within the time-period. Over the 12-Week treatment period is defined as Day 1 to Day of last dose.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period
Percentage of Rescue-free Days
Albuterol (Salbutamol) MDI or nebules was used as a rescue medication. Percentage of Rescue-Free Days is defined as sum of the number of days where the number of occasions of rescue medication use is zero within the time-period divided by total number of days with non-missing values within the time-period multiplied by 100 where the time-period is defined as follows: Week 1: Day 1-7; Week 2: Day 8 - 14; Week 3: Day 15-21; Week 4: Day 22-28; Week 5: Day 29-35; Week 6: Day 36-42; Week 7: Day 43-49; Week 8: Day 50-56; Week 9: Day 57-63; Week 10: Day 64-70; Week 11: Day 71-77; Week 12: Day 78 to Day of last dose; Over the 12-Week: Day 1 to Day of last dose.
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period
Plasma Concentration of Nemiralisib
Plasma samples were collected at indicated time points and analyzed for concentrations of Nemiralisb. Pharmacokinetic (PK) Population consists of all participants in the Safety population who had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values will be considered as non-missing values). Participants were summarized according to the treatment that they actually received.
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
Number of Participants Reporting Non-serious Adverse Events (Non-SAEs), SAEs and AE of Special Interest (AESI)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect and other important medical events. Safety Population consists of all randomized participants who received at least one dose of study treatment. Participants were summarized according to treatment that they actually received.
Up to Week 24
Number of Participants With Worst Case Post Baseline Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP) and Pulse Rate
The DBP, SBP and pulse rate were measured with participants seated at least 5 minutes before the assessments. Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the "To w/in Range or No Change" category. Participants are counted twice if the participant has values that changed "To Low" and "To High", so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value.
Up to Week 16
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
A single 12-lead ECG with a 15-second rhythm strip was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. Abnormal ECG findings are presented.
Screening, Days 14, 84, 112 and at early withdrawal
Number of Participants With Worst Case Post Baseline Clinical Chemistry Values
Blood samples were collected for the analysis of clinical chemistry parameters including: blood urea nitrogen (BUN), creatinine (Crt), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total and direct bilirubin, total protein and albumin (Alb). Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the "To w/in Range or No Change" category. Participants are counted twice if the participant has values that changed "To Low" and "To High", so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value.
Upto Week 16
Number of Participants With Worst Case Post Baseline Hematology Values
Blood samples were collected for the analysis of hematology parameters including: platelets (Pla), red blood cells count, Hemoglobin (Hb), Hematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), percentage reticulocytes, neutrophils (Neu), lymphocytes (Lym), monocytes, eosinophils, leukocytes (Leu) and basophils. Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the "To w/in Range or No Change" category. Participants are counted twice if the participant has values that changed "To Low" and "To High", so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value.
Upto Week 16
Number of Participants Reporting COPD Exacerbations
Participants reporting acute COPD exacerbations during the study period has been presented.
Up to Week 16
Plasma samples were collected at indicated time points and analyzed.
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
Maximum Observed Plasma Drug Concentration (Cmax) of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
Time to Reach Cmax (Tmax) of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
Plasma Drug Concentration at Pre-dose (Ctrough) of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
FG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
FG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
FG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
FG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
FG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
FG000276 subjects
FG00122 subjects
FG00291 subjects
FG00392 subjects
FG00490 subjects
FG00589 subjects
FG006278 subjects
COMPLETED
FG000244 subjects
FG00119 subjects
FG00279 subjects
FG00381 subjects
FG00475 subjects
FG00573 subjects
FG006233 subjects
NOT COMPLETED
FG00032 subjects
FG0013 subjects
FG00212 subjects
FG00311 subjects
FG00415 subjects
FG00516 subjects
FG00645 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00011 subjects
FG0011 subjects
FG0025 subjects
FG0036 subjects
FG0043 subjects
FG0056 subjects
FG00616 subjects
Physician Decision
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol-defined stopping criteria
FG0009 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Adverse Event
FG0004 subjects
FG0010 subjects
FG0025 subjects
FG0034 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
BG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
BG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
BG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
BG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
BG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
BG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000276
BG00122
BG00291
BG00392
BG00490
BG00589
BG006278
BG007938
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00065.4± 7.94
BG00167.8± 7.20
BG00263.1± 7.61
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00086
BG0016
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0002
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 84 Measured Post Bronchodilator
FEV1 is maximal amount of air exhaled forcefully from lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered 4 inhalations of albuterol (salbutamol) via MDI using spacer/valved-holding chamber or via one nebulized treatment. Post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and post-bronchodilator. Change from Baseline in clinic visit trough FEV1 at Day 84 measured post-bronchodilator is FEV1 measured prior to dosing and post-bronchodilator on Day 84 minus post-bronchodilator Baseline FEV1. Bayesian repeated measure model adjusted for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender was used. Posterior adjusted median change from Baseline and 95% highest posterior density (HPD) credible interval (CrI) was presented.
MITT Population consisted of all randomized participants who received at least 1 dose of study treatment.. Only those participants with data available at the specified data points were analyzed.
Posted
Median
95% Confidence Interval
Liters
Baseline and Day 84
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000215
OG00116
OG00272
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.052(0.018 to 0.091)
OG0010.031(-0.090 to 0.149)
OG0020.026(-0.036 to 0.084)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior adjusted median difference
-0.022
2-Sided
95
-0.143
0.103
Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.
Other
OG000
OG002
Secondary
Rate of Moderate and Severe Exacerbations Over 12-week Treatment Period
Moderate COPD exacerbations are defined as worsening symptoms of COPD treated with short-acting bronchodilators (SABDs) plus antibiotics and/or oral/systemic corticosteroids. Severe COPD exacerbations are defined as worsening symptoms of COPD that require hospitalization or visit to the emergency room. Severe exacerbation may also be associated with acute respiratory failure. Rate of exacerbations was analyzed using Bayesian Poisson model adjusting for length of on-treatment follow-up, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Posterior median exacerbation rate and 95% HPD CrI has been presented.
MITT Population.
Posted
Median
95% Confidence Interval
No.of exacerbation per 84 Days
Up to Week 12
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Number of Participants With Time to Next Moderate/Severe Exacerbation Following Index Exacerbation
Number of participants with time to next (on-treatment) moderate/severe exacerbation following index exacerbation during the 12-Week Treatment Period was defined as time from the date of randomization until the date of onset of the first moderate/severe exacerbation whilst on study treatment. Participants who did not have an exacerbation whilst on study treatment were censored at the date of their last dose of study treatment. Time to next exacerbation was analyzed using a Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.
MITT Population.
Posted
Count of Participants
Participants
Up to Week 12
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Change From Baseline in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator
Pulmonary function was measured by FEV1, defined as maximal amount of air exhaled forcefully from the lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered with 4 inhalations of albuterol via MDI using a spacer/valved-holding chamber or via 1 nebulized treatment. Pre-bronchodilator and post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and pre-bronchodilator and post-bronchodilator, respectively. Change from Baseline in clinic visit trough FEV1 at Days 14, 28, 56 and 84 measured pre-bronchodilator is defined as FEV1 measured prior to dosing and pre-bronchodilator on Days 14, 28, 56 and 84 minus pre-bronchodilator Baseline FEV1.
MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Liters
Baseline and Days 14, 28, 56 (pre and post bronchodilaor), 84 (pre-bronchodilator) and at hospital discharge (maximum 24 Weeks)
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Secondary
Change From Hospital Discharge in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator
Pulmonary function was measured by FEV1, defined as maximal amount of air exhaled forcefully from the lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10 to 30 minutes after participant was administered with 4 inhalations of albuterol via MDI using a spacer/valved-holding chamber or via 1 nebulized treatment. Pre-bronchodilator and post-bronchodilator Baseline FEV1 is defined as latest FEV1 measured prior to first dose of study treatment and pre-bronchodilator and post-bronchodilator, respectively. Change from hospital discharge in clinic visit trough FEV1 at Days 14, 28, 56 and 84 measured pre- and post-bronchodilator is defined as FEV1 measured prior to dosing and pre- and post-bronchodilator on Days 14, 28, 56 and 84 minus pre and post-bronchodilator Baseline FEV1.
MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Liters
Baseline and pre- and post-bronchodilator on Days 14, 28, 56 and 84
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Secondary
Percentage of Participants Achieving the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Definition of Recovery From the Index Exacerbation
EXACT patient-reported outcome (EXACT-PRO), 14-item instrument to capture occurrence, frequency, severity, and duration of exacerbations using an electronic diary (eDiary). Total score ranges from 0-100, higher score indicates more severe condition. Participants were required to complete EXACT-PRO every evening; however, on the day of randomization it was to be completed in the morning. Response was decrease in rolling average EXACT Total Score >=9 points from maximum observed value, sustained for >=7 days, with first of 7 days defined as recovery day. Analysis was performed using Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender.
MITT Population.
Posted
Number
Percentage of participants
Days 14, 28, 56 and 84
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Number of Participants With Time to Recovery From Index Exacerbation Using EXACT- PRO Tool
Time to EXACT-defined recovery from index exacerbation is defined as time from the date of randomization until date of the first EXACT-defined recovery day during the 12-Week Treatment Period. EXACT-defined recovery from the index exacerbation is defined as a decrease in the Rolling Average EXACT total Score >=9 points from the Maximum Observed Value, sustained for >=7 days, with the first of the 7 days defined as the recovery day. Analysis was performed using a Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Number of participants reporting events is presented.
MITT Population.
Posted
Count of Participants
Participants
From randomization to Week 12
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Mean Severity of Subsequent Health Care Resource Use (HCRU) Exacerbations Defined by EXACT
Severity of subsequent HCRU-defined exacerbations defined by EXACT was defined as the highest EXACT Total Score (not using the 3-day Rolling Average) during the period from date of onset of the subsequent HCRU-exacerbation until date of EXACT-defined recovery of subsequent exacerbation. EXACT-PRO, 14-item instrument to capture occurrence, frequency, severity, and duration of exacerbations using an eDiary. Total score ranges from 0-100, higher score indicates more severe condition. For participants with more than one subsequent exacerbation, severity was calculated for each subsequent exacerbation.
Severity was derived for participants from MITT Population who had reported subsequent exacerbation. Only those participants with data available at specified data points were analyzed (represented by n=X in the category title).
Posted
Mean
Standard Deviation
Scores on a scale
Up to Week 12
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Percentage of Responders Using the COPD Assessment Test (CAT) on Treatment Days 28, 56, and 84, and Following EXACT Defined Recovery From the Index Exacerbation
The CAT is a short, self-completed, 8-item questionnaire, each item was rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating severe condition. The percentage of responders using the CAT is defined as number of participants with a decrease from Baseline in CAT Total Score >=2 on or before Days 28, 56 and 84 divided by total number of participants in the MITT population. Percentage of responders using CAT was derived only for participants with a Baseline CAT Total Score >=2. Analysis was performed using a separate Bayesian logistic regression for each time point adjusting for treatment group, smoking status at baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.
MITT Population.
Posted
Number
Percentage of responders
Days 28, 56 and 84
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Secondary
Change From Baseline in CAT Total Score
The CAT is a short, self-completed, 8-item questionnaire, each item was rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score was calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating more severe condition. Baseline (Day 1) is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in CAT Total Score is defined as CAT Total Score on Days 28, 56 and 84 minus Baseline CAT Total Score. Analysis was performed using Bayesian repeated measures model adjusting for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Posterior adjusted median change from Baseline and 95% HPD CrI has been presented.
MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Median
95% Confidence Interval
Scores on a scale
Baseline and at Days 28, 56 and 84
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Secondary
Percentage of Responders on the St. George's Respiratory Questionnaire (SGRQ) Total Score as Measured by the SGRQ for COPD Participants (SGRQ-C) at Days 28, 56, and 84
SGRQ-C is a 40-item questionnaire designed specifically to focus on COPD participants and was scored equivalent to the SGRQ Total Score, ranging from 0 to 100, where higher scores reflect worse health-related quality of life. The percentage of responders on the SGRQ Total Score was derived for participants with a Baseline SGRQ Total Score >=4. Percentage of responders on the SGRQ Total Score is defined as number of participants with a decrease from Baseline in SGRQ Total Score >=4 on or before Days 28, 56 and 84 divided by total number of participants in the MITT population. Analysis was performed using a separate Bayesian logistic regression for each time point adjusting for treatment group, smoking status at baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.
MITT Population.
Posted
Number
Percentage of responders
Days 28, 56 and 84
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Change From Baseline in SGRQ Total Score at Days 28, 56 and 84
SGRQ-C is a 40-item questionnaire designed specifically to focus on COPD participants and was scored equivalent to SGRQ Total Score, ranging from 0 to 100, where higher scores reflect worse health-related quality of life. Scores on a scale were calculated as 100 multiplied by summed weights from positive items in questionnaire divided by sum of weights of all items in questionnaire. Baseline (Day 1) is defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in SGRQ Total Score is defined as SGRQ Total Score on Days 28, 56 and 84 minus Baseline SGRQ Total Score. Analysis was performed using Bayesian repeated measures model adjusting for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender. Posterior adjusted median change from Baseline and 95% HPD CrI was presented
MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Median
95% Confidence Interval
Scores on a scale
Baseline and Days 28, 56 and 84
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Secondary
Mean Number of Occasions of Rescue Medication Use Per Day
Albuterol (Salbutamol) MDI or nebules was used as a rescue medication. Rescue medication use was recorded as the number of occasions of rescue medication use each day. The mean number of occasions of rescue medication use per day is defined as sum of the number of occasions of rescue medication use each day within the time-period divided by the total number of days with non-missing values within the time-period. Over the 12-Week treatment period is defined as Day 1 to Day of last dose.
MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
No. of occasions of rescue use per day
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Percentage of Rescue-free Days
Albuterol (Salbutamol) MDI or nebules was used as a rescue medication. Percentage of Rescue-Free Days is defined as sum of the number of days where the number of occasions of rescue medication use is zero within the time-period divided by total number of days with non-missing values within the time-period multiplied by 100 where the time-period is defined as follows: Week 1: Day 1-7; Week 2: Day 8 - 14; Week 3: Day 15-21; Week 4: Day 22-28; Week 5: Day 29-35; Week 6: Day 36-42; Week 7: Day 43-49; Week 8: Day 50-56; Week 9: Day 57-63; Week 10: Day 64-70; Week 11: Day 71-77; Week 12: Day 78 to Day of last dose; Over the 12-Week: Day 1 to Day of last dose.
MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Mean
Standard Deviation
Percentage of rescue free days
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Plasma Concentration of Nemiralisib
Plasma samples were collected at indicated time points and analyzed for concentrations of Nemiralisb. Pharmacokinetic (PK) Population consists of all participants in the Safety population who had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values will be considered as non-missing values). Participants were summarized according to the treatment that they actually received.
PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Picograms per milliliter
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
ID
Title
Description
OG000
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 100 mcg
Other Pre-specified
Area Under the Concentration Time Curve (AUC) From Time Zero to 24 Hours [AUC(0-24)] of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*picograms per milliliter
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
ID
Title
Description
OG000
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Other Pre-specified
AUC From Time Zero to Time 't' [AUC(0-t)] of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*picograms per milliliter
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
ID
Title
Description
OG000
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Other Pre-specified
Maximum Observed Plasma Drug Concentration (Cmax) of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Picograms per milliliter
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
ID
Title
Description
OG000
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Other Pre-specified
Time to Reach Cmax (Tmax) of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
PK Population.
Posted
Median
Full Range
Hours
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
ID
Title
Description
OG000
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Other Pre-specified
Plasma Drug Concentration at Pre-dose (Ctrough) of Nemiralisib
Plasma samples were collected at indicated time points and analyzed.
PK Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Picograms per milliliter
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
ID
Title
Description
OG000
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Number of Participants Reporting Non-serious Adverse Events (Non-SAEs), SAEs and AE of Special Interest (AESI)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect and other important medical events. Safety Population consists of all randomized participants who received at least one dose of study treatment. Participants were summarized according to treatment that they actually received.
Safety Population.
Posted
Count of Participants
Participants
Up to Week 24
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Number of Participants With Worst Case Post Baseline Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP) and Pulse Rate
The DBP, SBP and pulse rate were measured with participants seated at least 5 minutes before the assessments. Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the "To w/in Range or No Change" category. Participants are counted twice if the participant has values that changed "To Low" and "To High", so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value.
Safety Population. Only those participants with data available at the specified data points were analyzed.
Posted
Count of Participants
Participants
Up to Week 16
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
A single 12-lead ECG with a 15-second rhythm strip was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. Abnormal ECG findings are presented.
Safety Population.
Posted
Count of Participants
Participants
Screening, Days 14, 84, 112 and at early withdrawal
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Secondary
Number of Participants With Worst Case Post Baseline Clinical Chemistry Values
Blood samples were collected for the analysis of clinical chemistry parameters including: blood urea nitrogen (BUN), creatinine (Crt), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total and direct bilirubin, total protein and albumin (Alb). Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the "To w/in Range or No Change" category. Participants are counted twice if the participant has values that changed "To Low" and "To High", so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Count of Participants
Participants
Upto Week 16
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Secondary
Number of Participants With Worst Case Post Baseline Hematology Values
Blood samples were collected for the analysis of hematology parameters including: platelets (Pla), red blood cells count, Hemoglobin (Hb), Hematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), percentage reticulocytes, neutrophils (Neu), lymphocytes (Lym), monocytes, eosinophils, leukocytes (Leu) and basophils. Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the "To w/in Range or No Change" category. Participants are counted twice if the participant has values that changed "To Low" and "To High", so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value.
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Posted
Count of Participants
Participants
Upto Week 16
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Secondary
Number of Participants Reporting COPD Exacerbations
Participants reporting acute COPD exacerbations during the study period has been presented.
Safety Population.
Posted
Count of Participants
Participants
Up to Week 16
ID
Title
Description
OG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
OG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Time Frame
Non-serious AEs and SAEs were collected up to Week 24
Description
Non-serious AEs and SAEs were summarized for the Safety Population.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants were administered a single oral inhalation of placebo via ELLIPTA dry powder inhaler (DPI) once daily in the morning for 12 weeks. Albuterol (salbutamol) metered-dose inhaler (MDI) or nebules were also provided to all participants as rescue medication.
1
276
23
276
31
276
EG001
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
0
22
2
22
1
22
EG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
3
91
9
91
14
91
EG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
1
92
13
92
19
92
EG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
0
90
16
90
25
90
EG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
0
89
6
89
36
89
EG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
1
278
26
278
101
278
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chroni obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0008 events8 affected276 at risk
EG0011 events1 affected22 at risk
EG0027 events6 affected91 at risk
EG0034 events4 affected92 at risk
EG004
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0004 events4 affected276 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected91 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected91 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Cystitis klebsiella
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected91 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Sinus arrhythmia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected91 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Neuroendocrine tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Enterocele
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected91 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Arterial thrombosis
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Swelling
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected91 at risk
EG003
Intracranial hematoma
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG00013 events13 affected276 at risk
EG0010 events0 affected22 at risk
EG00212 events10 affected91 at risk
EG00317 events11 affected92 at risk
EG00427 events23 affected90 at risk
EG00558 events31 affected89 at risk
EG006141 events96 affected278 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected276 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected91 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG00041 events23 affected276 at risk
EG0011 events1 affected22 at risk
EG0028 events6 affected91 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
75
OG00469
OG00558
OG006216
0.014
(-0.044 to 0.073)
OG0040.058(-0.002 to 0.118)
OG0050.049(-0.017 to 0.113)
OG0060.049(0.012 to 0.086)
Posterior adjusted median difference
-0.027
2-Sided
95
-0.098
0.036
Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.
Other
OG000
OG003
Posterior adjusted median difference
-0.038
2-Sided
95
-0.102
0.028
Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.
Other
OG000
OG004
Posterior adjusted median difference
0.005
2-Sided
95
-0.064
0.071
Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.
Other
OG000
OG005
Posterior adjusted median difference
-0.003
2-Sided
95
-0.075
0.061
Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.
Other
OG000
OG006
Posterior adjusted median difference
-0.004
2-Sided
95
-0.051
0.042
Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.
Other
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Title
Measurements
OG0000.31(0.25 to 0.39)
OG001NA(NA to NA)The participants randomized to Nemiralisib 12.5 mcg were excluded from this analysis due to insufficient participants with data.
OG0020.29(0.20 to 0.39)
OG0030.28(0.20 to 0.38)
OG0040.32(0.23 to 0.43)
OG0050.20(0.13 to 0.29)
OG0060.36(0.29 to 0.43)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Posterior median exacerbation rate ratio
0.92
2-Sided
95
0.60
1.40
Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for moderate/severe exacerbations has been presented.
Other
OG000
OG003
Posterior median exacerbation rate ratio
0.89
2-Sided
95
0.57
1.35
Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for moderate/severe exacerbations has been presented.
Other
OG000
OG004
Posterior median exacerbation rate ratio
1.01
2-Sided
95
0.65
1.50
Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for moderate/severe exacerbations has been presented.
Other
OG000
OG005
Posterior median exacerbation rate ratio
0.63
2-Sided
95
0.37
1.02
Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for moderate/severe exacerbations has been presented.
Other
OG000
OG006
Posterior median exacerbation rate ratio
1.13
2-Sided
95
0.85
1.52
Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for moderate/severe exacerbations has been presented.
Other
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Title
Measurements
OG00072
OG0013
OG00224
OG00325
OG00426
OG00515
OG00680
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior median hazard ratio
0.455
2-Sided
95
0.054
1.103
Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for time to next moderate/severe exacerbations has been presented.
Other
OG000
OG002
Posterior median hazard ratio
0.991
2-Sided
95
0.580
1.500
Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for time to next moderate/severe exacerbations has been presented.
Other
OG000
OG003
Posterior median hazard ratio
0.975
2-Sided
95
0.581
1.467
Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for time to next moderate/severe exacerbations has been presented.
Other
OG000
OG004
Posterior median hazard ratio
1.132
2-Sided
95
0.682
1.709
Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for time to next moderate/severe exacerbations has been presented.
Other
OG000
OG005
Posterior median hazard ratio
0.556
2-Sided
95
0.268
0.902
Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for time to next moderate/severe exacerbations has been presented.
Other
OG000
OG006
Posterior median hazard ratio
1.149
2-Sided
95
0.800
1.539
Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for time to next moderate/severe exacerbations has been presented.
Other
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Day 14, Pre, n=240, 20, 85, 83, 76, 76, 238
ParticipantsOG000240
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG00383
ParticipantsOG00476
ParticipantsOG00576
ParticipantsOG006238
Title
Measurements
OG0000.008± 0.2729
OG0010.100± 0.2511
OG002-0.021± 0.2657
OG003
Day 14, Post, n=248, 20, 86, 83, 77, 78, 241
ParticipantsOG000248
ParticipantsOG00120
ParticipantsOG00286
ParticipantsOG00383
Day 28, Pre, n=239, 20, 82, 79, 75, 71, 232
ParticipantsOG000239
ParticipantsOG00120
ParticipantsOG00282
ParticipantsOG00379
Day 28, Post, n=245, 19, 83, 81, 76, 72, 232
ParticipantsOG000245
ParticipantsOG00119
ParticipantsOG00283
ParticipantsOG00381
Day 56, Pre, n=230, 20, 78, 76, 73, 67, 224
ParticipantsOG000230
ParticipantsOG00120
ParticipantsOG00278
ParticipantsOG00376
Day 56, Post, n=237, 19, 78, 77, 74, 69, 224
ParticipantsOG000237
ParticipantsOG00119
ParticipantsOG00278
ParticipantsOG00377
Day 84, Pre, n=210, 17, 71, 73, 66, 58, 212
ParticipantsOG000210
ParticipantsOG00117
ParticipantsOG00271
ParticipantsOG00373
Hospital discharge, Pre, n=23, 2, 8, 8, 7, 3, 22
ParticipantsOG00023
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0038
Hospital discharge, Post, n=8, 2, 1, 1, 1, 0, 6
ParticipantsOG0008
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Day 14, Pre, n=20, 2, 8, 8, 6, 4, 20
ParticipantsOG00020
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG00620
Title
Measurements
OG0000.082± 0.2783
OG0010.355± 0.4207
OG0020.069± 0.3012
OG003
Day 14, Post, n=5, 2, 1, 1, 1, 0, 5
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Day 28, Pre, n=37, 2, 14, 8, 10, 9, 37
ParticipantsOG00037
ParticipantsOG0012
ParticipantsOG00214
ParticipantsOG0038
Day 28, Post, n=22, 2, 8, 1, 4, 4, 22
ParticipantsOG00022
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0031
Day 56, Pre, n=37, 2, 14, 8, 9, 10, 36
ParticipantsOG00037
ParticipantsOG0012
ParticipantsOG00214
ParticipantsOG0038
Day 56, Post, n=22, 2, 7, 1, 4, 5, 21
ParticipantsOG00022
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0031
Day 84, Pre, n=37, 2, 12, 8, 7, 10, 35
ParticipantsOG00037
ParticipantsOG0012
ParticipantsOG00212
ParticipantsOG0038
Day 84, Post, n=22, 2, 6, 1, 4, 5, 22
ParticipantsOG00022
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0031
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Day 14
Title
Measurements
OG00029
OG00127
OG00237
OG00329
OG00428
OG00524
OG00632
Day 28
Title
Measurements
OG00040
OG00141
OG00252
OG003
Day 56
Title
Measurements
OG00049
OG00145
OG00259
OG003
Day 84
Title
Measurements
OG00051
OG00150
OG00259
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior median odds ratio
1.01
2-Sided
95
0.21
2.30
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.37
2-Sided
95
0.76
2.17
Treatment comparison between placebo and nemiralisib 50 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
0.99
2-Sided
95
0.54
1.61
Treatment comparison between placebo and nemiralisib 100 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
0.94
2-Sided
95
0.50
1.49
Treatment comparison between placebo and nemiralisib 250 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
0.75
2-Sided
95
0.38
1.25
Treatment comparison between placebo and nemiralisib 500 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
1.16
2-Sided
95
0.77
1.63
Treatment comparison between placebo and nemiralisib 750 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior median odds ratio
1.21
2-Sided
95
0.36
2.69
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.53
2-Sided
95
0.82
2.33
Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
1.16
2-Sided
95
0.67
1.79
Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.12
2-Sided
95
0.63
1.74
Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
0.55
2-Sided
95
0.28
0.88
Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
1.08
2-Sided
95
0.72
1.49
Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior median odds ratio
1.00
2-Sided
95
0.30
2.17
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.46
2-Sided
95
0.84
2.27
Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
1.15
2-Sided
95
0.65
1.78
Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.09
2-Sided
95
0.62
1.67
Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
0.49
2-Sided
95
0.26
0.77
Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
1.04
2-Sided
95
0.71
1.42
Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior median odds ratio
1.08
2-Sided
95
0.32
2.38
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.29
2-Sided
95
0.70
2.00
Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
1.12
2-Sided
95
0.63
1.71
Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
0.95
2-Sided
95
0.55
1.48
Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
0.56
2-Sided
95
0.31
0.87
Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
1.08
2-Sided
95
0.73
1.47
Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Title
Measurements
OG000141
OG00111
OG00254
OG00350
OG00445
OG00534
OG006149
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior median hazard ratio
1.053
2-Sided
95
0.477
1.765
Treatment comparison between placebo and Nemiralisib 12.5 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median hazard ratio
1.200
2-Sided
95
0.840
1.597
Treatment comparison between placebo and Nemiralisib 50 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median hazard ratio
1.060
2-Sided
95
0.734
1.432
Treatment comparison between placebo and Nemiralisib 100 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median hazard ratio
1.030
2-Sided
95
0.719
1.413
Treatment comparison between placebo and Nemiralisib 250 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median hazard ratio
0.751
2-Sided
95
0.487
1.057
Treatment comparison between placebo and Nemiralisib 500 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median hazard ratio
1.149
2-Sided
95
0.899
1.426
Treatment comparison between placebo and Nemiralisib 750 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.
Other
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG00066
OG0013
OG00223
OG00325
OG00426
OG00515
OG00678
Title
Denominators
Categories
Moderate/Severe, n=66, 3, 23, 25, 26, 15, 78
ParticipantsOG00066
ParticipantsOG0013
ParticipantsOG00223
ParticipantsOG00325
ParticipantsOG00426
ParticipantsOG00515
ParticipantsOG00678
Title
Measurements
OG00053.3± 12.16
OG00164.6± 25.20
OG00259.8± 12.82
OG003
Moderate, n=55, 3, 15, 23, 17, 10, 63
ParticipantsOG00055
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00323
Severe, n=13, 1, 9, 3, 10, 6, 20
ParticipantsOG00013
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0033
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Day 28
Title
Measurements
OG00032
OG00136
OG00234
OG00339
OG00438
OG00534
OG00625
Day 56
Title
Measurements
OG00063
OG00150
OG00273
OG003
Day 84
Title
Measurements
OG00070
OG00155
OG00278
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior median odds ratio
1.22
2-Sided
95
0.35
2.70
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.11
2-Sided
95
0.63
1.77
Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
1.41
2-Sided
95
0.77
2.17
Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.28
2-Sided
95
0.71
2.00
Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
1.11
2-Sided
95
0.61
1.75
Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
0.70
2-Sided
95
0.46
0.99
Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior median odds ratio
0.64
2-Sided
95
0.20
1.41
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.53
2-Sided
95
0.84
2.46
Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
0.95
2-Sided
95
0.53
1.48
Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.36
2-Sided
95
0.74
2.16
Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
0.76
2-Sided
95
0.43
1.17
Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
0.93
2-Sided
95
0.63
1.27
Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior median odds ratio
0.54
2-Sided
95
0.16
1.20
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.53
2-Sided
95
0.79
2.56
Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
0.83
2-Sided
95
0.46
1.30
Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.16
2-Sided
95
0.62
1.86
Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
0.65
2-Sided
95
0.36
1.02
Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
0.85
2-Sided
95
0.57
1.17
Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Day 28, n=234, 19, 86, 80, 77, 74, 229
ParticipantsOG000234
ParticipantsOG00119
ParticipantsOG00286
ParticipantsOG00380
ParticipantsOG00477
ParticipantsOG00574
ParticipantsOG006229
Title
Measurements
OG000-4.7(-5.6 to -3.8)
OG001-2.3(-5.1 to 0.5)
OG002-4.0(-5.4 to -2.7)
OG003
Day 56, n=231, 20, 78, 77, 76, 69, 222
ParticipantsOG000231
ParticipantsOG00120
ParticipantsOG00278
ParticipantsOG00377
Day 84, n=218, 17, 75, 75, 69, 62, 213
ParticipantsOG000218
ParticipantsOG00117
ParticipantsOG00275
ParticipantsOG00375
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior adjusted median difference
2.4
2-Sided
95
-0.5
5.2
Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior adjusted median difference
0.7
2-Sided
95
-0.8
2.3
Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior adjusted median difference
0.8
2-Sided
95
-0.8
2.4
Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior adjusted median difference
-0.3
2-Sided
95
-2.0
1.2
Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior adjacent median difference
1.6
2-Sided
95
0.0
3.3
Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior adjusted median difference
0.0
2-Sided
95
-1.1
1.1
Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior adjusted median difference
2.3
2-Sided
95
-0.5
5.4
Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior adjusted median difference
0.8
2-Sided
95
-0.9
2.4
Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior adjusted median difference
-0.3
2-Sided
95
-1.9
1.4
Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior adjusted median difference
-0.5
2-Sided
95
-2.3
1.0
Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior adjusted median difference
0.4
2-Sided
95
-1.2
2.2
Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior adjusted median difference
-0.2
2-Sided
95
-1.4
1.0
Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior adjusted median difference
1.9
2-Sided
95
-1.4
5.1
Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior adjusted median difference
1.1
2-Sided
95
-0.7
2.8
Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior adjusted median difference
-0.5
2-Sided
95
-2.3
1.1
Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjsted median difference and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior adjusted median difference
-0.1
2-Sided
95
-1.9
1.7
Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior adjusted median difference
0.8
2-Sided
95
-0.9
2.8
Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior adjusted median difference
0.4
2-Sided
95
-0.8
1.7
Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Day 28
ParticipantsOG000234
ParticipantsOG00119
ParticipantsOG00286
ParticipantsOG00380
ParticipantsOG00477
ParticipantsOG00574
ParticipantsOG006229
Title
Measurements
OG00021
OG00114
OG00219
OG003
Day 56
ParticipantsOG000231
ParticipantsOG00120
ParticipantsOG00278
ParticipantsOG00377
Day 84
ParticipantsOG000218
ParticipantsOG00117
ParticipantsOG00275
ParticipantsOG00375
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior median odds ratio
0.51
2-Sided
95
0.03
1.41
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
0.87
2-Sided
95
0.42
1.47
Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
1.37
2-Sided
95
0.69
2.24
Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.78
2-Sided
95
0.95
2.91
Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
1.24
2-Sided
95
0.61
2.08
Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
0.95
2-Sided
95
0.60
1.40
Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior median odds ratio
0.54
2-Sided
95
0.14
1.16
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.27
2-Sided
95
0.74
1.98
Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
1.29
2-Sided
95
0.73
1.97
Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.47
2-Sided
95
0.83
2.27
Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
1.04
2-Sided
95
0.57
1.62
Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
1.10
2-Sided
95
0.75
1.50
Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior median odds ratio
0.63
2-Sided
95
0.17
1.39
Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior median odds ratio
1.27
2-Sided
95
0.72
2.01
Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior median odds ratio
1.13
2-Sided
95
0.64
1.79
Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior median odds ratio
1.35
2-Sided
95
0.75
2.14
Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior median odds ratio
0.94
2-Sided
95
0.53
1.45
Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior median odds ratio
1.03
2-Sided
95
0.71
1.43
Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.
Other
Nemiralisib 12.5 mcg
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Day 28, n=232, 19, 86, 78, 77, 72, 225
ParticipantsOG000232
ParticipantsOG00119
ParticipantsOG00286
ParticipantsOG00378
ParticipantsOG00477
ParticipantsOG00572
ParticipantsOG006225
Title
Measurements
OG000-7.7(-9.8 to -5.7)
OG001-5.7(-12.2 to 0.5)
OG002-8.2(-11.4 to -5.1)
OG003
Day 56, n=227, 20, 78, 77, 74, 68, 219
ParticipantsOG000227
ParticipantsOG00120
ParticipantsOG00278
ParticipantsOG00377
Day 84, n=218, 17, 74, 74, 69, 60, 209
ParticipantsOG000218
ParticipantsOG00117
ParticipantsOG00274
ParticipantsOG00374
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Posterior adjusted median difference
2.0
2-Sided
95
-4.8
8.3
Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior adjusted median difference
-0.5
2-Sided
95
-4.0
3.1
Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior adjusted median difference
-2.9
2-Sided
95
-6.2
1.1
Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior adjusted median difference
-3.2
2-Sided
95
-6.7
0.4
Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior adjusted median difference
-0.1
2-Sided
95
-4.0
3.5
Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior adjusted median difference
-0.2
2-Sided
95
-2.7
2.3
Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior adjusted median difference
4.1
2-Sided
95
-2.5
11.0
Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior adjusted median difference
-1.2
2-Sided
95
-4.8
2.5
Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior adjusted median difference
-2.7
2-Sided
95
-6.3
1.1
Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior adjusted median difference
-3.3
2-Sided
95
-7.3
0.4
Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior adjusted median difference
-0.8
2-Sided
95
-4.6
3.0
Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior adjusted median difference
-0.4
2-Sided
95
-2.9
2.5
Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG001
Posterior adjusted median difference
2.4
2-Sided
95
-4.8
9.4
Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG002
Posterior adjusted median difference
-0.2
2-Sided
95
-4.1
3.6
Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG003
Posterior adjusted median difference
-2.3
2-Sided
95
-6.1
1.8
Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG004
Posterior adjusted median difference
-1.8
2-Sided
95
-5.7
2.3
Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG005
Posterior adjusted median difference
-0.3
2-Sided
95
-4.5
3.8
Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG000
OG006
Posterior adjusted median difference
1.2
2-Sided
95
-1.7
4.0
Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.
Other
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Week 1, n=254, 21, 87, 88, 80, 79, 254
ParticipantsOG000254
ParticipantsOG00121
ParticipantsOG00287
ParticipantsOG00388
ParticipantsOG00480
ParticipantsOG00579
ParticipantsOG006254
Title
Measurements
OG0001.699± 1.7674
OG0012.112± 2.2977
OG0021.633± 1.4320
OG003
Week 2, n=259, 21, 88, 89, 80, 82, 252
ParticipantsOG000259
ParticipantsOG00121
ParticipantsOG00288
ParticipantsOG00389
Week 3, n=256, 21, 90, 88, 80, 81, 245
ParticipantsOG000256
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG00388
Week 4, n=250, 21, 89, 87, 81, 77, 243
ParticipantsOG000250
ParticipantsOG00121
ParticipantsOG00289
ParticipantsOG00387
Week 5, n=251, 20, 88, 85, 78, 76, 240
ParticipantsOG000251
ParticipantsOG00120
ParticipantsOG00288
ParticipantsOG00385
Week 6, n=250, 20, 86, 84, 78, 72, 234
ParticipantsOG000250
ParticipantsOG00120
ParticipantsOG00286
ParticipantsOG00384
Week 7, n=250, 20, 85, 83, 77, 71, 231
ParticipantsOG000250
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG00383
Week 8, n=250, 20, 84, 83, 77, 71, 231
ParticipantsOG000250
ParticipantsOG00120
ParticipantsOG00284
ParticipantsOG00383
Week 9, n=244, 20, 82, 81, 76, 71, 229
ParticipantsOG000244
ParticipantsOG00120
ParticipantsOG00282
ParticipantsOG00381
Week 10, n=241, 20, 81, 80, 73, 71, 227
ParticipantsOG000241
ParticipantsOG00120
ParticipantsOG00281
ParticipantsOG00380
Week 11, n=241, 20, 79, 80, 73, 71, 226
ParticipantsOG000241
ParticipantsOG00120
ParticipantsOG00279
ParticipantsOG00380
Week 12, n=240, 20, 78, 80, 73, 70, 225
ParticipantsOG000240
ParticipantsOG00120
ParticipantsOG00278
ParticipantsOG00380
Over 12 Week, n=273, 21, 91, 91, 86, 83, 268
ParticipantsOG000273
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00391
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Week 1, n=254, 21, 87, 88, 80, 79, 254
ParticipantsOG000254
ParticipantsOG00121
ParticipantsOG00287
ParticipantsOG00388
ParticipantsOG00480
ParticipantsOG00579
ParticipantsOG006254
Title
Measurements
OG00034.898± 37.7118
OG00136.076± 44.3182
OG00229.849± 38.3385
OG003
Week 2, n=259, 21, 88, 89, 80, 82, 252
ParticipantsOG000259
ParticipantsOG00121
ParticipantsOG00288
ParticipantsOG00389
Week 3, n=256, 21, 90, 88, 80, 81, 245
ParticipantsOG000256
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG00388
Week 4, n=250, 21, 89, 87, 81, 77, 243
ParticipantsOG000250
ParticipantsOG00121
ParticipantsOG00289
ParticipantsOG00387
Week 5, n=251, 20, 88, 85, 78, 76, 240
ParticipantsOG000251
ParticipantsOG00120
ParticipantsOG00288
ParticipantsOG00385
Week 6, n=250, 20, 86, 84, 78, 72, 234
ParticipantsOG000250
ParticipantsOG00120
ParticipantsOG00286
ParticipantsOG00384
Week 7, n=250, 20, 85, 83, 77, 71, 231
ParticipantsOG000250
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG00383
Week 8, n=250, 20, 84, 83, 77, 71, 231
ParticipantsOG000250
ParticipantsOG00120
ParticipantsOG00284
ParticipantsOG00383
Week 9, n=244, 20, 82, 81, 76, 71, 229
ParticipantsOG000244
ParticipantsOG00120
ParticipantsOG00282
ParticipantsOG00381
Week 10, n=241, 20, 81, 80, 73, 71, 227
ParticipantsOG000241
ParticipantsOG00120
ParticipantsOG00281
ParticipantsOG00380
Week 11, n=241, 20, 79, 80, 73, 71, 226
ParticipantsOG000241
ParticipantsOG00120
ParticipantsOG00279
ParticipantsOG00380
Week 12, n=240, 20, 78, 80, 73, 70, 225
ParticipantsOG000240
ParticipantsOG00120
ParticipantsOG00278
ParticipantsOG00380
Over 12 Week, n=273, 21, 91, 91, 86, 83, 268
ParticipantsOG000273
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00391
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG0005
OG00122
OG00224
OG00319
OG00420
OG00573
Title
Denominators
Categories
Day 14, Pre-dose, n=2, 19, 24, 16, 18, 69
ParticipantsOG0002
ParticipantsOG00119
ParticipantsOG00224
ParticipantsOG00316
ParticipantsOG00418
ParticipantsOG00569
Title
Measurements
OG000113.6± 6
OG00162.0± 46
OG002142.8± 44
OG003
Day 14, 0-1 hour, n=4, 19, 24, 15, 18, 67
ParticipantsOG0004
ParticipantsOG00119
ParticipantsOG00224
ParticipantsOG00315
Day 14, >1-6 hours, n=4, 20, 23, 15, 18, 65
ParticipantsOG0004
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00315
Day 28, Pre-dose, n=2, 18, 23, 16, 16, 67
ParticipantsOG0002
ParticipantsOG00118
ParticipantsOG00223
ParticipantsOG00316
Day 28, 0-1 hour, n=3, 19, 23, 16, 15, 63
ParticipantsOG0003
ParticipantsOG00119
ParticipantsOG00223
ParticipantsOG00316
Day 28, >1-6 hours, n=3, 18, 23, 16, 14, 64
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00223
ParticipantsOG00316
OG003
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG0005
OG00122
OG00224
OG00319
OG00420
OG00573
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary population pharmacokinetic (Pop PK) analyses were not conducted
OG001NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG002NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG004NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG005NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG0005
OG00122
OG00224
OG00319
OG00420
OG00573
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG001NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG002NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG004NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG005NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG0005
OG00122
OG00224
OG00319
OG00420
OG00573
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG001NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG002NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG004NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG005NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG0005
OG00122
OG00224
OG00319
OG00420
OG00573
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)This was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG001NA(NA to NA)This was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG002NA(NA to NA)This was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003NA(NA to NA)This was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG004NA(NA to NA)This was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG005NA(NA to NA)This was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG0005
OG00122
OG00224
OG00319
OG00420
OG00573
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG001NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG002NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG003NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG004NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG005NA± NAThis was a conditional secondary endpoint for which results are not available because development of the associated asset was terminated and therefore secondary Pop PK analyses were not conducted
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Any non-SAE
Title
Measurements
OG00031
OG0011
OG00214
OG00319
OG00425
OG00536
OG006101
Any SAE
Title
Measurements
OG00023
OG0012
OG0029
OG003
Any AESI
Title
Measurements
OG0009
OG0010
OG00210
OG003
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000271
OG00121
OG00291
OG00392
OG00488
OG00588
OG006266
Title
Denominators
Categories
DBP, To low
Title
Measurements
OG0008
OG0013
OG0023
OG0030
OG0044
OG0054
OG0067
DBP, To within range/no change
Title
Measurements
OG000260
OG00117
OG00285
OG003
DBP, To high
Title
Measurements
OG0003
OG0011
OG0023
OG003
Pulse rate, To low
Title
Measurements
OG0001
OG0010
OG0020
OG003
Pulse rate,To within range/no change
Title
Measurements
OG000265
OG00121
OG00284
OG003
Pulse rate, To high
Title
Measurements
OG0005
OG0010
OG0027
OG003
SBP, To low
Title
Measurements
OG00011
OG0011
OG0025
OG003
SBP, To withinn range/no change
Title
Measurements
OG000250
OG00118
OG00283
OG003
SBP, To high
Title
Measurements
OG00010
OG0012
OG0023
OG003
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Screening
Title
Measurements
OG00093
OG00110
OG00225
OG00337
OG00428
OG00521
OG00686
Day 14
Title
Measurements
OG00088
OG0018
OG00224
OG003
Day 84
Title
Measurements
OG00079
OG0018
OG00222
OG003
Day 112
Title
Measurements
OG00077
OG00111
OG00228
OG003
Early withdrawal
Title
Measurements
OG0003
OG0010
OG0022
OG003
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Alb,To low, n=266, 21, 91, 90, 87, 85, 263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
ParticipantsOG00487
ParticipantsOG00585
ParticipantsOG006263
Title
Measurements
OG0002
OG0010
OG0020
OG003
Alb,w/in range/no change,n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG003
Alb,To high,n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
Cal,To low, n=266, 21, 90, 90, 87, 85, 263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG00390
Cal,w/in range/no change,n=266,21,90,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG003
Cal,To high, n=266,21,90,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG00390
Crt,To low, n=266, 21, 91, 90, 87, 85, 263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
Crt,w/in range/no change,n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG003
Crt,To high, n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
Glu,To low, n=266, 21, 91, 90, 87, 85, 263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
Glu,w/in range/no change,n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG003
Glu,To high, n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
Pot,To low, n=266, 21, 90, 90, 87, 85, 263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG00390
Pot,w/in range/no change,n=266,21,90,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG003
Pot,To high, n=266,21,90,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00290
ParticipantsOG00390
Sod,To low, n=266, 21, 91, 90, 87, 85, 263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
Sod,w/in range/no change,n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG003
Sod,To high, n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
BUN,To low, n=266, 21, 91, 90, 87, 85, 263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
BUN,w/in range/no change,n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG003
BUN,To high, n=266,21,91,90,87,85,263
ParticipantsOG000266
ParticipantsOG00121
ParticipantsOG00291
ParticipantsOG00390
Participants were administered a single oral inhalation of 12.5 micrograms (mcg) nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG002
Nemiralisib 50 mcg
Participants were administered a single oral inhalation of 50 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG003
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Hb,To low, n=260, 20, 90, 90, 84, 81, 254
ParticipantsOG000260
ParticipantsOG00120
ParticipantsOG00290
ParticipantsOG00390
ParticipantsOG00484
ParticipantsOG00581
ParticipantsOG006254
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hb,w/in range/no change,n=260,20,90,90,84,81,254
ParticipantsOG000260
ParticipantsOG00120
ParticipantsOG00290
ParticipantsOG003
Hb,To high,n=260, 20, 90, 90, 84, 81, 254
ParticipantsOG000260
ParticipantsOG00120
ParticipantsOG00290
ParticipantsOG00390
Leu,To low,n=259, 20, 90, 90, 83, 78, 251
ParticipantsOG000259
ParticipantsOG00120
ParticipantsOG00290
ParticipantsOG00390
Leu,w/in range/no change,n=259,20,90,90,83,78,251
ParticipantsOG000259
ParticipantsOG00120
ParticipantsOG00290
ParticipantsOG003
Leu,To high, n=259,20,90,90,83,78,251
ParticipantsOG000259
ParticipantsOG00120
ParticipantsOG00290
ParticipantsOG00390
Lym,To low, n=256, 20, 85, 88, 82, 77, 249
ParticipantsOG000256
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG00388
Lym,w/in range/no change,n=256,20,85,88,82,77,249
ParticipantsOG000256
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG003
Lym,To high,n=256,20,85,88,82,77,249
ParticipantsOG000256
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG00388
Neu, To low, n=256,20,85,88,82,77,249
ParticipantsOG000256
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG00388
Neu,w/in range/no change,n=256,20,85,88,82,77,249
ParticipantsOG000256
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG003
Neu,To high, n=256,20,85,88,82,77,249
ParticipantsOG000256
ParticipantsOG00120
ParticipantsOG00285
ParticipantsOG00388
Pla,To low, n=253, 19, 88, 90, 84, 78, 245
ParticipantsOG000253
ParticipantsOG00119
ParticipantsOG00288
ParticipantsOG00390
Pla,w/in range/no change,n=253,19,88,90,84,78,245
ParticipantsOG000253
ParticipantsOG00119
ParticipantsOG00288
ParticipantsOG003
Pla,To high, n=253,19,88,90,84,78,245
ParticipantsOG000253
ParticipantsOG00119
ParticipantsOG00288
ParticipantsOG00390
Nemiralisib 100 mcg
Participants were administered a single oral inhalation of 100 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG004
Nemiralisib 250 mcg
Participants were administered a single oral inhalation of 250 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG005
Nemiralisib 500 mcg
Participants were administered a single oral inhalation of 500 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
OG006
Nemiralisib 750 mcg
Participants were administered a single oral inhalation of 750 mcg nemiralisib via ELLIPTA DPI once daily in the morning for 12 weeks. Albuterol (salbutamol) MDI or nebules were also provided to all participants as rescue medication.
Units
Counts
Participants
OG000276
OG00122
OG00291
OG00392
OG00490
OG00589
OG006278
Title
Denominators
Categories
Title
Measurements
OG0008
OG0011
OG0026
OG0034
OG0044
OG0053
OG00617
5 events
4 affected
90 at risk
EG0053 events3 affected89 at risk
EG00617 events17 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
2 events
2 affected
92 at risk
EG0043 events3 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
1 events
1 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
1 events
1 affected
92 at risk
EG0042 events2 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0051 events1 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0051 events1 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0051 events1 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0051 events1 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0051 events1 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0041 events1 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
1 events
1 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0061 events1 affected278 at risk
0 events
0 affected
92 at risk
EG0040 events0 affected90 at risk
EG0050 events0 affected89 at risk
EG0060 events0 affected278 at risk
2 events
2 affected
92 at risk
EG0043 events3 affected90 at risk
EG0055 events5 affected89 at risk
EG0062 events2 affected278 at risk
10 events
8 affected
92 at risk
EG0045 events4 affected90 at risk
EG0052 events2 affected89 at risk
EG00618 events15 affected278 at risk
-0.013
± 0.2509
OG0040.053± 0.2958
OG0050.041± 0.2738
OG0060.023± 0.2561
ParticipantsOG00477
ParticipantsOG00578
ParticipantsOG006241
Title
Measurements
OG0000.034± 0.2707
OG0010.075± 0.2425
OG0020.010± 0.2168
OG003-0.050± 0.2477
OG0040.054± 0.2983
OG0050.073± 0.2655
OG0060.044± 0.2216
ParticipantsOG00475
ParticipantsOG00571
ParticipantsOG006232
Title
Measurements
OG0000.017± 0.2585
OG0010.081± 0.2661
OG002-0.034± 0.2875
OG003-0.010± 0.2333
OG0040.064± 0.2592
OG0050.016± 0.2713
OG0060.020± 0.2512
ParticipantsOG00476
ParticipantsOG00572
ParticipantsOG006232
Title
Measurements
OG0000.036± 0.2647
OG0010.059± 0.2575
OG0020.004± 0.2183
OG003-0.034± 0.2401
OG0040.049± 0.2639
OG0050.027± 0.2369
OG0060.029± 0.2307
ParticipantsOG00473
ParticipantsOG00567
ParticipantsOG006224
Title
Measurements
OG0000.005± 0.2295
OG001-0.006± 0.2636
OG002-0.024± 0.3210
OG0030.011± 0.2415
OG0040.022± 0.2522
OG005-0.004± 0.2233
OG006-0.001± 0.2858
ParticipantsOG00474
ParticipantsOG00569
ParticipantsOG006224
Title
Measurements
OG0000.020± 0.2614
OG001-0.002± 0.2252
OG002-0.012± 0.2524
OG0030.004± 0.2373
OG0040.026± 0.2556
OG005-0.011± 0.2260
OG0060.011± 0.2470
ParticipantsOG00466
ParticipantsOG00558
ParticipantsOG006212
Title
Measurements
OG0000.000± 0.2566
OG0010.003± 0.2232
OG002-0.049± 0.2549
OG0030.005± 0.2668
OG0040.015± 0.2739
OG0050.007± 0.2461
OG0060.010± 0.2829
ParticipantsOG0047
ParticipantsOG0053
ParticipantsOG00622
Title
Measurements
OG0000.071± 0.1586
OG0010.168± 0.2652
OG0020.108± 0.3888
OG0030.056± 0.1782
OG0040.052± 0.3481
OG0050.162± 0.1426
OG0060.075± 0.1974
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.134± 0.1514
OG0010.153± 0.0933
OG0020.083± NANot applicable (NA) indicates standard deviation could not be calculated as single participant was analyzed.
OG003-0.076± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG0040.094± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG006-0.006± 0.1079
-0.049
± 0.1882
OG004-0.069± 0.4905
OG0050.173± 0.5137
OG0060.002± 0.2343
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG0000.056± 0.3372
OG0010.431± 0.5190
OG0020.119± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG0030.310± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG004-0.305± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG006-0.021± 0.1326
ParticipantsOG00410
ParticipantsOG0059
ParticipantsOG00637
Title
Measurements
OG0000.026± 0.2691
OG0010.261± 0.5204
OG0020.012± 0.2910
OG003-0.085± 0.2072
OG0040.012± 0.4020
OG0050.030± 0.4029
OG006-0.046± 0.2639
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG00622
Title
Measurements
OG0000.034± 0.2779
OG0010.334± 0.5614
OG0020.130± 0.2327
OG0030.130± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG0040.009± 0.2006
OG0050.007± 0.3237
OG006-0.094± 0.2293
ParticipantsOG0049
ParticipantsOG00510
ParticipantsOG00636
Title
Measurements
OG0000.019± 0.2282
OG0010.106± 0.6138
OG0020.019± 0.3509
OG0030.014± 0.1938
OG004-0.074± 0.3847
OG005-0.042± 0.1840
OG006-0.054± 0.2942
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG00621
Title
Measurements
OG000-0.014± 0.2896
OG0010.139± 0.6838
OG0020.042± 0.3068
OG0030.098± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG004-0.056± 0.3572
OG005-0.072± 0.1490
OG006-0.135± 0.2410
ParticipantsOG0047
ParticipantsOG00510
ParticipantsOG00635
Title
Measurements
OG0000.007± 0.2741
OG001-0.027± 0.4554
OG0020.121± 0.2770
OG003-0.081± 0.1738
OG004-0.072± 0.4391
OG0050.043± 0.2511
OG006-0.062± 0.2816
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG00622
Title
Measurements
OG000-0.039± 0.2610
OG0010.133± 0.5162
OG0020.037± 0.3341
OG0030.108± NANA indicates standard deviation could not be calculated as single participant was analyzed.
OG0040.021± 0.3151
OG0050.006± 0.2180
OG006-0.106± 0.2956
43
OG00442
OG00527
OG00642
52
OG00450
OG00531
OG00650
54
OG00450
OG00537
OG00654
50.5
± 10.76
OG00447.5± 13.95
OG00557.6± 10.30
OG00651.9± 10.78
ParticipantsOG00417
ParticipantsOG00510
ParticipantsOG00663
Title
Measurements
OG00053.1± 11.54
OG00160.0± 26.56
OG00257.4± 11.08
OG00350.0± 11.15
OG00446.3± 14.20
OG00553.8± 9.28
OG00650.0± 10.17
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG00620
Title
Measurements
OG00054.0± 15.53
OG00183.0± NANA indicates standard deviation could not be calculated as only one participant was analyzed.