ID
41348
Description
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.
Lien
https://clinicaltrials.gov/ct2/show/NCT00039858
Mots-clés
Versions (1)
- 02/09/2020 02/09/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
2 septembre 2020
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 4.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Medical History
- StudyEvent: ODM
Description
Medical / Surgical / Invasive Procedure History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Description
No significant medical history
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [1,3]
- C0332197
Description
Medical history: Ear, nose, and throat
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
Description
Medical history: Ear, nose, and throat - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Eyes
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
Description
Medical history: Eyes - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Respiratory
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
Description
Medical history: Respiratory - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Congenital Heart Disease
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
Description
Medical history: Congenital Heart Disease - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Cardiac Arrhythmia
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
Description
Medical history: Cardiac Arrhythmia
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Hypertension
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
Description
Medical history: Hypertension - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
- UMLS CUI [1,3]
- C1521902
Description
Medical histroy: Other cardiovascular diseases
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Description
Medical histroy: Other cardiovascular diseases - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Description
Medical histroy: Other cardiovascular diseases
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Description
Medical histroy: Other cardiovascular diseases - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Description
Medical history: Gastrointestinal
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
Description
Medical history: Gastrointestinal - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Hepatobiliary and pancreas
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0267792
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0030286
Description
Medical history: Hepatobiliary and pancreas - specify
Type de données
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
Description
Medical history: Urinary system
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
Description
Medical history: Urinary system - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Reproductive system
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
Description
Medical history: Reproductive system - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Neurologic
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
Description
Medical history: Neurologic - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Blood and lymphatic
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
Description
Medical history: Blood and lymphatic - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Diabetes/Glucose Intolerance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0271650
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0011849
Description
Medical history: Diabetes/Glucose Intolerance - specify
Type de données
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
Description
Medical history: Other endocrine diseases
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
Description
Medical history: Other endocrine diseases - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Description
Medical history: Musculoskeletal
Type de données
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
Description
Medical history: Musculoskeletal - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Skin
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
Description
Medical history: Skin - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Psychiatric
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Description
Medical history: Psychiatric - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Allergies
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
Description
Medical history: Allergies - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C1521902
Description
Medical history: Other
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
Description
Medical history: Other - specify
Type de données
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])