ID
41481
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 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
Trefwoorden
Versies (1)
- 24-10-20 24-10-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 oktober 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
30-Day Followup (+/- 14 Days)
- StudyEvent: ODM
Beschrijving
Followup Visit
Alias
- UMLS CUI-1
- C0589121
Beschrijving
Telephone call replacing visit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0302186
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0545082
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C3694716
Beschrijving
(0000-2359)
Datatype
time
Alias
- UMLS CUI [1,1]
- C0589121
- UMLS CUI [1,2]
- C0040223
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Blood pressure - systolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure - diastolic
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Respiratory rate
Datatype
integer
Maateenheden
- per min.
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Heart rate
Datatype
text
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Body temperature
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Body temperature unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Body system examined
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C0031809
Beschrijving
(one per line)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [1,3]
- C0443172
Beschrijving
No change in physical examination
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0442739
- UMLS CUI [1,2]
- C0031809
Beschrijving
Please mark all events that occurred during dosing:
Alias
- UMLS CUI-1
- C2347784
Beschrijving
If None, check this Box and leave the following fields blank.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347784
- UMLS CUI [1,2]
- C0549184
Beschrijving
Venous thrombosis
Datatype
text
Alias
- UMLS CUI [1]
- C0042487
Beschrijving
Venous thrombosis - location
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0450429
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042487
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pulmonary embolus
Datatype
text
Alias
- UMLS CUI [1]
- C0034065
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0011008
Beschrijving
Arterial thrombosis
Datatype
text
Alias
- UMLS CUI [1]
- C0151942
Beschrijving
Arterial thrombosis - location
Datatype
text
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0450429
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0151942
- UMLS CUI [1,2]
- C0011008
Beschrijving
Clotting in external circuit that requires immediate intervention
Datatype
text
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
Beschrijving
Clotting in external circuit that requires immediate intervention - specify circuit location
Datatype
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
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1]
- C0949072
- UMLS CUI [2,1]
- C1708545
- UMLS CUI [2,2]
- C0205253
- UMLS CUI [3]
- C0011008
Beschrijving
Death due to thromboembolic complication
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
- UMLS CUI [1,4]
- C1148348
Beschrijving
Amputation due to thromboembolic complication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0002688
- UMLS CUI [1,2]
- C0040038
- UMLS CUI [1,3]
- C0009566
Beschrijving
(dd-mmm-yyyy)
Datatype
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])