ID

41343

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 This Form has to be filled in at the screening visit. It is used to record whether Informed Consent/Assent has been given by the Subject and also demographic data of the Subject.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

Keywords

  1. 8/31/20 8/31/20 -
  2. 9/2/20 9/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 2, 2020

DOI

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License

Creative Commons BY-NC 4.0

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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

Informed Consent/Assent, Demographics

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Description

Study centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient #
Description

patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Informed Consent/Assent
Description

Informed Consent/Assent

Alias
UMLS CUI-1
C0021430
Date consent form/assent signed:
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1]
C2985782
UMLS CUI [2,1]
C5205794
UMLS CUI [2,2]
C0011008
Time consent form/assent signed:
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1]
C5206390
UMLS CUI [2,1]
C5205794
UMLS CUI [2,2]
C0040223
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

gender

Data type

text

Alias
UMLS CUI [1]
C0079399
If patient is < 6 months old, number weeks gestation:
Description

Duration of gestation

Data type

integer

Measurement units
  • weeks
Alias
UMLS CUI [1]
C0460089
weeks
Corrected gestational age
Description

*Minimum corrected gestational age must be 37 weeks. If <44 weeks, a head ultrasound is required per protocol. (Record head ultrasound results on page 19 - Head Ultrasound Form.)

Data type

integer

Measurement units
  • weeks
Alias
UMLS CUI [1]
C3831006
weeks
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Other race, specify:
Description

Other race, specify

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C3845569

Similar models

Informed Consent/Assent, Demographics

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Item Group
Informed Consent/Assent
C0021430 (UMLS CUI-1)
Date of informed consent/assent
Item
Date consent form/assent signed:
date
C2985782 (UMLS CUI [1])
C5205794 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Informed consent time
Item
Time consent form/assent signed:
time
C5206390 (UMLS CUI [1])
C5205794 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Duration of gestation
Item
If patient is < 6 months old, number weeks gestation:
integer
C0460089 (UMLS CUI [1])
Corrected age
Item
Corrected gestational age
integer
C3831006 (UMLS CUI [1])
Item
Race
text
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
Asian (Asian)
CL Item
Black (Black)
CL Item
Caucasian (Caucasian)
CL Item
Hispanic (Hispanic)
CL Item
Other, Specify: (Other)
Other race, specify
Item
Other race, specify:
text
C0034510 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])

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