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The primary objective of this study is to evaluate the effectiveness of TRELEGY ELLIPTA on health status in participants with symptomatic COPD. The secondary objective is to evaluate the effectiveness of TRELEGY ELLIPTA on dyspnea and lung function in participants with symptomatic COPD. TRELEGY and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving TRELEGY ELLIPTA | Experimental | Participants will receive FF/UMEC/VI, inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FF/UMEC/VI | Drug | FF/UMEC/VI will be administered in a single inhaler Trelegy Ellipta. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in COPD Assessment Test (CAT) Score at Week 12 | The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, pre-dose) and at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Medical Research Council (mMRC) Grading System at Week 12 (Patient Version) | mMRC(Patient Version[Pt.V]) was used to assess breathlessness state of participant before and after treatment. mMRC (Pt V) was completed by each participant firstly, without supervision.Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact;where 0=only get breathless with strenuous exercise;1=get short of breath when hurrying on the level/walking up a slight hill;2=walk slower than people of same age on the level because of breathlessness/have to stop for breath when walking at own pace on the level;3=stop for breath after walking about 100 yards/after a few minutes on the level;4=too breathless to leave house/breathless when dressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dongguan | 523326 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40704458 | Background | Ma J, Dou F, Zhou W, Li L, Zhu J, Zhang Y, Zhou L, Su L, Dong L, He Y, Ye A, Slade D, Zheng J. Real-world effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol in Chinese patients with symptomatic chronic obstructive pulmonary disease (COPD): a post-marketing, prospective, multicenter, observational study. Curr Med Res Opin. 2025 Jul;41(7):1363-1372. doi: 10.1080/03007995.2025.2536600. Epub 2025 Jul 29. |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 463 participants were enrolled in this study, however only 460 participants (3 participants were never dosed) were dosed into the study to receive Trelegy creating the Full Analysis Set (FAS) (All participants who were enrolled into the study and took at least one dose of Trelegy).
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| ID | Title | Description |
|---|---|---|
| FG000 | Trelegy (FF/UMEC/VI ELLIPTA) | Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate [FF] 100 microgram [ug] / umeclidinium [UMEC] 62.5 ug / vilanterol [VI] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 27, 2023 | Aug 21, 2024 |
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| Baseline (Day 1, pre-dose) and at Week 12 |
| Change From Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale at Week 12 (Physician Version) | mMRC(Physician Version[PV]) was used to assess breathlessness state of participant before and after treatment. Physicians completed mMRC(PV) through their observation. Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact; where 0=no breathlessness except on strenuous exercise; 1=shortness of breath when hurrying on the level ground or walking up a slight hill; 2=walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3=stops for breath after walking about 100 yards or after few minutes on level ground; 4=too breathless to leave house or breathless when dressing or undressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value. | Baseline (Day 1, pre-dose) and at Week 12 |
| Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, pre-dose) and at Week 12 |
| Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12 | The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded-off. Percentage of participants having >=2 unit decrease in CAT score from Baseline at week 12 has been presented. | Baseline (Day 1, pre-dose) and at Week 12 |
| Change From Baseline in COPD Assessment Test (CAT) Score at Week 4 | The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value. | Baseline (Day 1, pre-dose) and at Week 4 |
| Number of Participants With Trelegy Related Non-serious Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Up to 251 days |
| Number of Participants With Trelegy Related Serious Adverse Events (SAEs) | A SAE is defined as any serious adverse event that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, a suspected transmission of any infectious agent via an authorized medicinal product or other situations as judged by physician. | Up to 251 days |
| Number of Participants With Trelegy Related AEs Leading to the Discontinuation | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Up to 251 days |
| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristic data are reported for the Full Analysis Set (FAS) which included all participants who were enrolled into the study and took at least one dose of Trelegy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trelegy (FF/UMEC/VI ELLIPTA) | Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate [FF] 100 microgram [ug] / umeclidinium [UMEC] 62.5 ug / vilanterol [VI] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 COPD Assessment Test (CAT) Score at Week 12 | The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1, pre-dose) and at Week 12 |
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| Secondary | Change From Baseline in Modified Medical Research Council (mMRC) Grading System at Week 12 (Patient Version) | mMRC(Patient Version[Pt.V]) was used to assess breathlessness state of participant before and after treatment. mMRC (Pt V) was completed by each participant firstly, without supervision.Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact;where 0=only get breathless with strenuous exercise;1=get short of breath when hurrying on the level/walking up a slight hill;2=walk slower than people of same age on the level because of breathlessness/have to stop for breath when walking at own pace on the level;3=stop for breath after walking about 100 yards/after a few minutes on the level;4=too breathless to leave house/breathless when dressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1, pre-dose) and at Week 12 |
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| Secondary | Change From Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale at Week 12 (Physician Version) | mMRC(Physician Version[PV]) was used to assess breathlessness state of participant before and after treatment. Physicians completed mMRC(PV) through their observation. Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact; where 0=no breathlessness except on strenuous exercise; 1=shortness of breath when hurrying on the level ground or walking up a slight hill; 2=walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3=stops for breath after walking about 100 yards or after few minutes on level ground; 4=too breathless to leave house or breathless when dressing or undressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1, pre-dose) and at Week 12 |
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| Secondary | Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | Mean | Standard Deviation | Liters | Baseline (Day 1, pre-dose) and at Week 12 |
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| Secondary | Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12 | The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded-off. Percentage of participants having >=2 unit decrease in CAT score from Baseline at week 12 has been presented. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1, pre-dose) and at Week 12 |
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| Secondary | Change From Baseline in COPD Assessment Test (CAT) Score at Week 4 | The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1, pre-dose) and at Week 4 |
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| Secondary | Number of Participants With Trelegy Related Non-serious Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. | Posted | Count of Participants | Participants | Up to 251 days |
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| Secondary | Number of Participants With Trelegy Related Serious Adverse Events (SAEs) | A SAE is defined as any serious adverse event that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, a suspected transmission of any infectious agent via an authorized medicinal product or other situations as judged by physician. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. | Posted | Count of Participants | Participants | Up to 251 days |
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| Secondary | Number of Participants With Trelegy Related AEs Leading to the Discontinuation | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. | Posted | Count of Participants | Participants | Up to 251 days |
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All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trelegy (FF/UMEC/VI ELLIPTA) | Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate [FF] 100 microgram [ug] / umeclidinium [UMEC] 62.5 ug / vilanterol [VI] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks. | 2 | 460 | 19 | 460 | 10 | 460 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumonia pseudomonal | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Cerebral thrombosis | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
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| Intracranial mass | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
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| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Respiratory tract irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2023 | Aug 21, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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