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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
  7. 7. Medical Specialty
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
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    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
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      1. Thoracic Surgery
      1. Trauma/Orthopedics
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    1. 7.15. Urology
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Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome

- 11/11/20 - 1 form, 4 itemgroups, 41 items, 1 language
Itemgroups: Administrative Data, Chest X-ray, Cultures and clinical findings, Treatment and Outcome
Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome) is to be filled out whenever applicable. In case of suspected pneumonia, pneumonia diagnosis must be confirmed by chest X-ray. Confirmed diagnosis of pneumonia must be recorded as an Adverse Event. A chest X-ray should be obtained for subjects who experience a lower respiratory tract infection requiring treatment with antibiotics for determination of the presence of pneumonia. Ancillary data should represent symptoms from initial presentation.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Patient's Diary Card 1: Screening/Run-In Visit 1

- 12/7/18 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Administrative data, Daily Assessments
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652 - Visit 1 - Day 0 - Dose 1

- 3/6/19 - 1 form, 25 itemgroups, 142 items, 1 language
Itemgroups: Administrative data, CHECK FOR STUDY CONTINUATION, HEMATOLOGY / BIOCHEMISTRY, HEMATOLOGY, BIOCHEMISTRY, LDH, URINALYSIS, Urinalysis (Dipstick) Test, RANDOMISATION / TREATMENT ALLOCATION, VACCINE ADMINISTRATION, VACCINE, VACCINE NON-ADMINISTRATION, IMMEDIATE POST-VACCINATION OBSERVATION, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, Temperature, Fatigue, Headache, Gastrointestinal symptoms, Malaise, Myalgia, UNSOLICITED ADVERSE EVENTS
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Form D; Patient Symptom Assessment; Topotecan Post-Study Minimal Follow-Up Report (Month of Report; Outcome, Form D)

- 5/4/21 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Administrative, Form D, Patient Symptom Assessment, Patient Symptom Assessment , Topotecan Post-Study Minimal Follow-Up Report: Month of Report, Topotecan Post-Study Minimal Follow-Up Report: Outcome, Topotecan Post-Study Minimal Follow-Up Report: Form D - (To be completed if the patient died), Topotecan Post-Study Minimal Follow-Up Report: Investigator's Signature
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

- 3/11/21 - 1 form, 4 itemgroups, 19 items, 1 language
Itemgroups: Total Nasal Symptom Scores, VAS, Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Genetic Screening For HLA-B*5701 in Patients with HIV Abacavir Hypersensitivity Reaction Record NCT00340080 - Genetic Screening For HLA-B*5701 Abacavir Hypersensitivity Reaction Record NCT00340080

- 4/19/17 - 1 form, 1 itemgroup, 70 items, 1 language
Itemgroup: Abacavir Hypersensitivity Reaction Record
NCT00340080 / VIIV-CNA106030 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Abacavir Hypersensitivity Reaction Record Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Bogen 1 Bestehende medizinische Symptome DRKS00005243 NCT01657604 CML - Bogen 1 Bestehende medizinische Symptome

- 9/20/21 - 1 form, 4 itemgroups, 25 items, 2 languages
Itemgroups: Allgemeine Angaben, Symptome, SAE, Kommentar
German CML Study Group http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

Rotterdem Symptom Checklist (RSCL) Week 36 Mepolizumab HES NCT00086658 - Rotterdem Symptom Checklist (RSCL) Week 36

- 7/15/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Symptom checklist
Study part: Rotterdem Symptom Checklist (RSCL) Week 36/ Early Withdrawal Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Rotterdem Symptom Checklist (RSCL) Week 38 Mepolizumab HES NCT00086658 - Rotterdem Symptom Checklist (RSCL) Week 38

- 6/5/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Symptom checklist
Study part: Rotterdem Symptom Checklist (RSCL) Week 38.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Rotterdem Symptom Checklist (RSCL) Week 12 Mepolizumab HES NCT00086658 - Rotterdem Symptom Checklist (RSCL) Week 12

- 6/5/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Symptom checklist
Study part: Rotterdem Symptom Checklist (RSCL) Week 12.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Rotterdem Symptom Checklist (RSCL) Week 24 Mepolizumab HES NCT00086658 - Rotterdem Symptom Checklist (RSCL) Week 24

- 6/5/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Symptom checklist
Study part: Rotterdem Symptom Checklist (RSCL) Week 24.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Rotterdem Symptom Checklist (RSCL) Day 1 Pre-Infusion Mepolizumab HES NCT00086658 - Rotterdem Symptom Checklist (RSCL) Day 1 Pre-Infusion

- 6/5/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Symptom checklist
Study part: Rotterdem Symptom Checklist (RSCL) Day 1 Pre-Infusion.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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