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Table of contents
  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
Selected data models

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- 10/24/20 - 1 form, 14 itemgroups, 71 items, 1 language
Itemgroups: Administrative Data, SAE during study, Demography, SAE, Cause of SAE other that investigational product, Seriousness of adverse event, Medical conditions explaining SAE, Other risk factors relevant to SAE, Details of investigational product, Concomitant medications related to SAE, Comments, Details of relevant assessments, Reporting investigator information, Additional or Follow-Up Information
- 10/24/20 - 1 form, 5 itemgroups, 32 items, 1 language
Itemgroups: Administrative Data, Followup visit, Vital Signs, Physical examination, Clinical Endpoints
- 10/24/20 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, Comments
- 10/24/20 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Administrative Data, HIT assay additional information report
- 10/21/20 - 1 form, 3 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Status, AE Status
- 10/21/20 - 1 form, 4 itemgroups, 20 items, 1 language
Itemgroups: Administrative Data, Clinical Endpoints, Occurrence of Thrombosis, Thromboembolic Complications
- 10/21/20 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Administrative Data, Vital Signs
- 10/21/20 - 1 form, 3 itemgroups, 19 items, 1 language
Itemgroups: Administrative Data, No concomitant medications, Concomitant medications, except for continuous infusions
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on Identifier: NCT00039858 - See Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. The Concomitant Medications (Non-Continuous Infusion) Form has to be filled in each time any change in medication (except for those administered as a continuous infusion) occurs during the Study. Please use one Instance of this Form per medication administered.
- 10/21/20 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Concomitant medications - continuous infusion, Concomitant medications - continuous infusion
- 10/21/20 - 1 form, 3 itemgroups, 22 items, 1 language
Itemgroups: Administrative Data, Adverse Events, Adverse Events