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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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Main CRF (Treatment Period 2, Day 1-2) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 16 itemgroups, 123 items, 1 language
Itemgroups: Investigational Product Day 1, Investigational Product Day 2, Hematology Day 1 Pre-Dose, Clinical chemistry Day 1 Pre-Dose, Urinalysis Day 1 Pre-Dose, Vital Signs Day 1, Vital Signs Day 2, 12-Lead Electrocardiogram Day 1, 12-Lead Electrocardiogram Day 2, FEV1 Day 1, Pharmacokinetic sampling Day 1, Potassium and Glucose Day 1, Pharmacokinetic Urine lnterval Collection Data Day 1, Hematology Day 1 Post-Dose, Clinical chemistry Day 1 Post-Dose, Urinalysis Day 1 Post-Dose
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Main CRF (Treatment Period 2, Day 3-6) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 5 itemgroups, 39 items, 1 language
Itemgroups: Vital Signs Day 3-6, 12-Lead Electrocardiogram Day 3-6, FEV1 Day 3-6, Potassium Day 5-6, Investigational Product Day 3-6
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Main CRF (Treatment Period 1, Day 3-6) - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 5 itemgroups, 39 items, 1 language
Itemgroups: Vital Signs Day 3-6, 12-Lead Electrocardiogram Day 3-6, FEV1 Day 3-6, Potassium Day 5-6, Investigational Product Day 3-6
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Eligibility Hypoxia-Induced Pulmonary Artery Hypertension NCT00260819

- 9/17/21 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia; ODM derived from: https://clinicaltrials.gov/show/NCT00260819

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Screening visit

- 9/17/21 - 1 form, 18 itemgroups, 108 items, 1 language
Itemgroups: Demography, Vital signs, 12-lead ECG, 12-Lead ECG, Abnormality, Holter Electrocardiography, Summary Report, Holter Electrocardiography, Summary Report, Electrocardiogram abnormal, Medical conditions, Physical Examination, History of Tobacco Use, HIV screen, Alcohol consumption, Drug screen, Ethanol measurement, Laboratory Procedures; Chemistry, Clinical, Laboratory Procedures; Haematologic tests, Laboratory Procedures; Urinalysis, Pharmacokinetic aspects, Blood, Inclusion, Exclusion Criteria
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Eligibility Stage IV Non-Small Cell Lung Cancer NCT02426658

- 9/17/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3; ODM derived from: https://clinicaltrials.gov/show/NCT02426658

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; Vital Signs; 12-Lead ECG Abnormalities

- 9/17/21 - 1 form, 4 itemgroups, 43 items, 1 language
Itemgroups: Concomitant Medication, 12-Lead /Holter/Telemetry ECG, Vital Signs, 12-Lead ECG Abnormalities
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Eligibility Hypertension, Pulmonary NCT00615823

- 9/17/21 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Atorvastatin in Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00615823

Eligibility Pulmonary Arterial Hypertension NCT02032836

- 9/17/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Comparative PK PD Study in PAH Patients (Fox vs. I-Neb); ODM derived from: https://clinicaltrials.gov/show/NCT02032836

Eligibility Pulmonary Arterial Hypertension NCT02234141

- 9/17/21 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
GS-4997 in Adults With Pulmonary Arterial Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02234141

Eligibility Severe Persistent Asthma NCT00954850

- 9/15/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A National Program for Severe Asthma: The Canadian Severe Asthma Network; ODM derived from: https://clinicaltrials.gov/show/NCT00954850

Eligibility Persistent Asthma NCT02040779

- 8/18/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02040779

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