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- 16.02.19 - 1 Formular, 7 Itemgruppen, 34 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Solicited Adverse Events Record - Local Symptoms, Other Local Symptoms (Day 0 to Day 29), Medication, Solicited Adverse Events Record - General Symptoms, Solicited Adverse Events - Temperature, Other General Symptoms (Day 0 to Day 29)
- 16.02.19 - 1 Formular, 7 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Solicited Adverse Events, Solicited Adverse Events Record - Local Symptoms, Solicited Adverse Events - General Symptoms, Solicited Adverse Events Record - General Symptoms, Solicited Adverse Events - Fever, Unsolicited Adverse Events
Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on Identifier: NCT00321373 Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to document if the subject has had any adverse events in the course of the study. It should be filled out at the date of vaccination. SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: · results in death · is life threatening · results in persistent or significant disability / incapacity · requires in-patient hospitalization · prolongation of existing hospitalization · is a congenital anomaly / birth defect in the offspring of a study subject · In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event the investigator becomes aware of, please fill in a Serious Adverse Event(SAE) report and fax it to GSK Biologicals Study Contact for SAE reporting within 24 hours. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1