ID
41481
Descripción
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 Followup Visit. It records Vital Signs, changes from the Post-Treatment Exam and (re)occurence of specified Events.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Palabras clave
Versiones (1)
- 24/10/20 24/10/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
24 de octubre de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
30-Day Followup (+/- 14 Days)
- StudyEvent: ODM
Descripción
Followup Visit
Alias
- UMLS CUI-1
- C0589121
Descripción
Telephone call replacing visit
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0302186
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0545082
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1]
- C3694716
Descripción
(0000-2359)
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0040223
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Blood pressure - systolic
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descripción
Blood pressure - diastolic
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descripción
Respiratory rate
Tipo de datos
integer
Unidades de medida
- per min.
Alias
- UMLS CUI [1]
- C0231832
Descripción
Heart rate
Tipo de datos
text
Unidades de medida
- bpm
Alias
- UMLS CUI [1]
- C0018810
Descripción
Body temperature
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0005903
Descripción
Body temperature unit
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Descripción
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Descripción
Body system examined
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C0031809
Descripción
(one per line)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [1,3]
- C0443172
Descripción
No change in physical examination
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0442739
- UMLS CUI [1,2]
- C0031809
Descripción
Please mark all events that occurred during dosing:
Alias
- UMLS CUI-1
- C2347784
Descripción
If None, check this Box and leave the following fields blank.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347784
- UMLS CUI [1,2]
- C0549184
Descripción
Venous thrombosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0042487
Descripción
Venous thrombosis - location
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0450429
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0011008
Descripción
Pulmonary embolus
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034065
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0011008
Descripción
Arterial thrombosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0151942
Descripción
Arterial thrombosis - location
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0450429
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0011008
Descripción
Clotting in external circuit that requires immediate intervention
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
Descripción
Clotting in external circuit that requires immediate intervention - specify circuit location
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
- UMLS CUI [3,1]
- C2348235
- UMLS CUI [3,2]
- C0015354
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
- UMLS CUI [3]
- C0011008
Descripción
Death due to thromboembolic complication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
- UMLS CUI [1,4]
- C1148348
Descripción
Amputation due to thromboembolic complication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0002688
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Descripción
(dd-mmm-yyyy)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0002688
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
- UMLS CUI [1,4]
- C0011008
Similar models
30-Day Followup (+/- 14 Days)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3,1])
C0015354 (UMLS CUI [3,2])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C1148348 (UMLS CUI [1,4])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])