Stichworte
Asthma ×
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Inhaltsverzeichnis
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
Ausgewählte Datenmodelle

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- 15.01.19 - 1 Formular, 8 Itemgruppen, 37 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Hematology Data, Clinical Chemistry Data, Urinalysis, Urinalysis: Dip Stick, Urinalysis: Sedimentary Microcopy, Serology Screen, Pregnancy Test
Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. The study session 1.1 includes forms for reapeat screening (unscheduled. This document contains the forms: Hematology Data, Clinical Chemistry Data and Urinalysis. It has to filled in for screening, sessions 2, 3, 4, 5, 6 and 7. It also has to be filled in for Session 1.1. It also contains the worksheet for Serology Screen. It has to be filled in for screening (session 1). Furthermore this document contains the form pregnancy test. It has to be filled in for treatment period 1-5.
- 14.01.19 - 1 Formular, 4 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Randomisation Number, Investigational product - Container Number, Investigational product - Day 1-7, treatment confirmation
- 10.01.19 - 1 Formular, 10 Itemgruppen, 43 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, General Information, Liver event, Investigational product (Liver), Pharmacokinetics (Liver PK), Liver disease medical conditions, DRUG RELATED LIVER DISEASE CONDITIONS, Other liver disease conditions, Other medical conditions, Alcohol intake at onset of liver event
- 10.01.19 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Vital Signs
- 10.01.19 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pulmonary function tests
- 10.01.19 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pharmacogenetic (PGx) research withdrawl of consent
- 10.01.19 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dummy Dose
- 10.01.19 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, IP Device Malfunction (IPDEVMAl), Reasons for device malfunction
- 10.01.19 - 1 Formular, 3 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Vital Signs, Body measurement
- 09.01.19 - 1 Formular, 4 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Electronically transferred laboratory data - Haematology, Electronically transferred laboratory data - Clinical chemistry, Electronically transferred laboratory data - Urinalysis