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Sommario
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
    1. 7.1. Anästhesie
    1. 7.2. Dermatologie
    1. 7.3. HNO
    1. 7.4. Geriatrie
    1. 7.5. Gynäkologie/Geburtshilfe
    1. 7.6. Innere Medizin
      1. Hämatologie
      1. Infektiologie
      1. Kardiologie/Angiologie
      1. Pneumologie
      1. Gastroenterologie
      1. Nephrologie
      1. Endokrinologie/Stoffwechsel
      1. Rheumatologie
    1. 7.7. Neurologie
    1. 7.8. Augenheilkunde
    1. 7.9. Palliativmedizin
    1. 7.10. Pathologie/Rechtsmedizin
    1. 7.11. Kinderheilkunde
    1. 7.12. Psychiatrie/Psychosomatik
    1. 7.13. Radiologie
    1. 7.14. Chirurgie
      1. Allgemein-/Viszeralchirurgie
      1. Neurochirurgie
      1. Plastische Chirurgie
      1. Herz-/Thoraxchirurgie
      1. Unfallchirurgie/Orthopädie
      1. Gefäßchirurgie
    1. 7.15. Urologie
    1. 7.16. Zahnmedizin/MKG
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Study conclusion

- 21.11.18 - 1 modulo, 1 ItemGroup, 4 elementi, 1 linguaggio
ItemGroup: Study conclusion
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

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Investigator's Signature

- 21.11.18 - 1 modulo, 1 ItemGroup, 3 elementi, 1 linguaggio
ItemGroup: Investigator Signature
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

End of Study Record - GSK Milveterol COPD 100527

- 19.06.17 - 1 modulo, 1 ItemGroup, 5 elementi, 1 linguaggio
ItemGroup: End of Study Record
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

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - End of Study

- 06.04.18 - 1 modulo, 8 itemgroups, 41 elementi, 1 linguaggio
Itemgroups: Administrative Data, Status of treatment blind, PGx-Pharmacogenetic Research, Concomitant Medication, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's signature
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains the "end of study" form (except for Adverse Events, see Form "Adverse Events").

study conclusion events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 08.08.17 - 1 modulo, 6 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: administrative data, study conclusion, medical device, pregnancy, investigator's comment, investigator's signature
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Study Conclusion

- 20.08.19 - 1 modulo, 3 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Clinical Trials, Conclusion, Investigator Signature
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Study conclusion

- 06.12.18 - 1 modulo, 2 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Study conclusion details, If YES, complete primary reason for withdrawal
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

Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970 - Early Withdrawal

- 19.02.19 - 1 modulo, 7 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Candidiasis, Examination, Smoking Status, Date of Visit, Assessment Date, Laboratory Procedures, Liver, Adverse Event, Evaluation, Vital Signs, Pre-dose
Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Follow-Up Contact

- 06.12.18 - 1 modulo, 1 ItemGroup, 2 elementi, 1 linguaggio
ItemGroup: Follow-Up contact question
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

GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463 - Early Withdrawal

- 05.04.18 - 1 modulo, 6 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Early Withdrawal, Pre-Dose Vital Signs, Candidiasis examination, Electronically transferred lab data, Liver Events Assessment, Smoking Status
Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Early Withdrawal

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Study Conclusion, Status of treatment blind, PGx research withdrawal of consent, Pregnancy information

- 19.11.20 - 1 modulo, 6 itemgroups, 24 elementi, 1 linguaggio
Itemgroups: Administrative Data, Study Conclusion, Status of treatment: Blind, Pharmacogenetic Research Withdrawal of Consent, Saliva Sample Destruction, Pregnancy Information, Signatures
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 (Study Conclusion, Status of treatment blind, PGx research withdrawal of consent, Pregnancy information) is to be filled out at the End of the Study.

Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970 - End of Study

- 25.02.19 - 1 modulo, 9 itemgroups, 19 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Blinded Clinical Study, Status, Follow-Up, Date of visit, Assessment Date, Clinical Trials, Conclusion, Experimental drug, Double-Blind Method, Pharmacogenetics, Consent Withdrawn, Investigator Signature, Pregnancy, Information
Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

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