ID
41348
Beschrijving
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 The Medical History Form has to be filled in at the screening visit. It is used to record details of medical history and prior surgical and other invasive procedures. To be completed within 7 days before treatment initiation.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Trefwoorden
Versies (1)
- 02-09-20 02-09-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
2 september 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Medical History
- StudyEvent: ODM
Beschrijving
Medical / Surgical / Invasive Procedure History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Beschrijving
No significant medical history
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [1,3]
- C0332197
Beschrijving
Medical history: Ear, nose, and throat
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
Beschrijving
Medical history: Ear, nose, and throat - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Eyes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
Beschrijving
Medical history: Eyes - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Respiratory
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
Beschrijving
Medical history: Respiratory - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Congenital Heart Disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
Beschrijving
Medical history: Congenital Heart Disease - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Cardiac Arrhythmia
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
Beschrijving
Medical history: Cardiac Arrhythmia
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Hypertension
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
Beschrijving
Medical history: Hypertension - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical histroy: Other cardiovascular diseases
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Beschrijving
Medical histroy: Other cardiovascular diseases - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschrijving
Medical histroy: Other cardiovascular diseases
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Beschrijving
Medical histroy: Other cardiovascular diseases - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschrijving
Medical history: Gastrointestinal
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
Beschrijving
Medical history: Gastrointestinal - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Hepatobiliary and pancreas
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0267792
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0030286
Beschrijving
Medical history: Hepatobiliary and pancreas - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0267792
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0030286
- UMLS CUI [2,3]
- C1521902
Beschrijving
Medical history: Urinary system
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
Beschrijving
Medical history: Urinary system - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Reproductive system
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
Beschrijving
Medical history: Reproductive system - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Neurologic
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
Beschrijving
Medical history: Neurologic - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Blood and lymphatic
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
Beschrijving
Medical history: Blood and lymphatic - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Diabetes/Glucose Intolerance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0271650
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0011849
Beschrijving
Medical history: Diabetes/Glucose Intolerance - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0271650
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0011849
- UMLS CUI [2,3]
- C1521902
Beschrijving
Medical history: Other endocrine diseases
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
Beschrijving
Medical history: Other endocrine diseases - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschrijving
Medical history: Musculoskeletal
Datatype
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
Beschrijving
Medical history: Musculoskeletal - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Skin
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
Beschrijving
Medical history: Skin - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Psychiatric
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Beschrijving
Medical history: Psychiatric - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Allergies
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
Beschrijving
Medical history: Allergies - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C1521902
Beschrijving
Medical history: Other
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
Beschrijving
Medical history: Other - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Similar models
Medical History
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0455610 (UMLS CUI-2)
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0395797 (UMLS CUI [1,2])
C0395797 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0015397 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0035204 (UMLS CUI [1,2])
C0035204 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0152021 (UMLS CUI [1,2])
C0152021 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0003811 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0020538 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0017178 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0267792 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0030286 (UMLS CUI [2,2])
C0267792 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0030286 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0042075 (UMLS CUI [1,2])
C0042075 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0178829 (UMLS CUI [1,2])
C0178829 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0027765 (UMLS CUI [1,2])
C0027765 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0851353 (UMLS CUI [1,2])
C0851353 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0271650 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0271650 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0014130 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0014130 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0037274 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])