ID
41351
Beskrivning
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 Post-Treatment Physical Exam Form is used to record the physical examination prior to initiation of treatment. For patients receiving Argatroban for no more than 14 days, complete within 24 hours of final infusion completion. For patients receiving Argatroban for more than 14 days [continuing with non-study Argatroban], complete within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.
Länk
https://clinicaltrials.gov/ct2/show/NCT00039858
Nyckelord
Versioner (1)
- 2020-09-03 2020-09-03 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 september 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Post-Treatment Physical Exam
- StudyEvent: ODM
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Respiratory Rate
Datatyp
integer
Måttenheter
- per min.
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
Body Height
Datatyp
float
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Body Height Unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Body Temperature
Datatyp
float
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Body Temperature Unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beskrivning
Body Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Body Weight Unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beskrivning
Pre-treatment Physical Exam
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C2709094
Beskrivning
Physical Examination: General Appearance - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [1,3]
- C0443172
Beskrivning
Physical Examination: Skin - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0437750
- UMLS CUI [1,2]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0437750
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [1,3]
- C0443172
Beskrivning
Physical Examination: Head/Neck - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0460004
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0460004
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Lymph Nodes - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Breasts - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Heart - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Lungs - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Abdomen - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Genitalia - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0017420
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0017420
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Extremities - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Neurologic - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0027853
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0027853
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Rectal - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199900
- UMLS CUI [1,3]
- C0449438
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199900
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
- UMLS CUI [1,5]
- C0443172
Beskrivning
Physical Examination: Other - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beskrivning
Specify body system
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Beskrivning
Physical Examination: Other - status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beskrivning
Specify body system
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beskrivning
(abnormality should associate with Medical History, see Medical History Form)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [1,4]
- C0443172
Similar models
Post-Treatment Physical Exam
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2709094 (UMLS CUI-2)
C0449438 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0460004 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0460004 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0024204 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0024204 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0199850 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0199850 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0018787 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0018787 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0024109 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0024109 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0000726 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0000726 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0017420 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0017420 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0015385 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0015385 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0027853 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0027853 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0199900 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0199900 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0443172 (UMLS CUI [1,5])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])