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Pharmacokinetics ×
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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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- 9/14/20 - 1 form, 4 itemgroups, 42 items, 1 language
Itemgroups: Administrative Data, Anticoagulation therapy taken prior to study, Pharmacokinetic sample, heparin induced thrombocytopenia testing, Argatroban Indication
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 ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 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. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form has to be filled in at the screening visit. Section Pre-Treatment Anticoagulation has to be filled in within 96 hours prior to treatment initiation and additionally, if Heparin was administered, ACT or aPTT have to be measured before Heparin administration. Section Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use has to be filled in within 96 hours before treatment initiation administration. Section Indication for Argatroban Use records the indications on behalf of which is the medicament administered.
- 9/3/20 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data, Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results
- 8/10/20 - 1 form, 16 itemgroups, 16 items, 1 language
Itemgroups: Dosing date and time, Predose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours
- 8/10/20 - 1 form, 16 itemgroups, 16 items, 1 language
Itemgroups: Dosing date and time, Predose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours
- 8/10/20 - 1 form, 14 itemgroups, 14 items, 1 language
Itemgroups: Dosing date and time, Predose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours