ID
41348
Beschreibung
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
Stichworte
Versionen (1)
- 02.09.20 02.09.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
2. September 2020
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Medical History
- StudyEvent: ODM
Beschreibung
Medical / Surgical / Invasive Procedure History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Beschreibung
No significant medical history
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [1,3]
- C0332197
Beschreibung
Medical history: Ear, nose, and throat
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
Beschreibung
Medical history: Ear, nose, and throat - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Eyes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
Beschreibung
Medical history: Eyes - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Respiratory
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
Beschreibung
Medical history: Respiratory - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Congenital Heart Disease
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
Beschreibung
Medical history: Congenital Heart Disease - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Cardiac Arrhythmia
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
Beschreibung
Medical history: Cardiac Arrhythmia
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Hypertension
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
Beschreibung
Medical history: Hypertension - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical histroy: Other cardiovascular diseases
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Beschreibung
Medical histroy: Other cardiovascular diseases - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschreibung
Medical histroy: Other cardiovascular diseases
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Beschreibung
Medical histroy: Other cardiovascular diseases - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschreibung
Medical history: Gastrointestinal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
Beschreibung
Medical history: Gastrointestinal - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Hepatobiliary and pancreas
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0267792
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0030286
Beschreibung
Medical history: Hepatobiliary and pancreas - specify
Datentyp
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
Beschreibung
Medical history: Urinary system
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
Beschreibung
Medical history: Urinary system - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Reproductive system
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
Beschreibung
Medical history: Reproductive system - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Neurologic
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
Beschreibung
Medical history: Neurologic - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Blood and lymphatic
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
Beschreibung
Medical history: Blood and lymphatic - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Diabetes/Glucose Intolerance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0271650
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0011849
Beschreibung
Medical history: Diabetes/Glucose Intolerance - specify
Datentyp
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
Beschreibung
Medical history: Other endocrine diseases
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
Beschreibung
Medical history: Other endocrine diseases - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschreibung
Medical history: Musculoskeletal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
Beschreibung
Medical history: Musculoskeletal - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Skin
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
Beschreibung
Medical history: Skin - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Psychiatric
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Beschreibung
Medical history: Psychiatric - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Allergies
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
Beschreibung
Medical history: Allergies - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C1521902
Beschreibung
Medical history: Other
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
Beschreibung
Medical history: Other - specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Ähnliche Modelle
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])