ID

41472

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 - See https://clinicaltrials.gov/ct2/show/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. The Concomitant Medications (Continuous Infusion) Form has to be filled in each time any change in medication administered as continous infusion occurs during the Study. Please use one Instance of this Form per medication administered.

Link

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

Keywords

Versions (1)
  1. 10/21/20 10/21/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 21, 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

English

Concomitant Medications (Continuous Infusion)

1 forms  
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
Check if (additional) supplemental instance of this form was used.
Description

Check this box on all instances except for the last one.

Data type

boolean

Alias
UMLS CUI [1]
C1706499
Instance Number
Description

Fill in the instance number, starting from 1. On all instances except for the last one, the preceding box has to be checked.

Data type

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C2348184
Concomintant Medications (Continuous Infusion)
Description

Concomintant Medications (Continuous Infusion)

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1511497
Check if No Continuous Infusion Concomitant Medications were given:
Description

Otherwise, please complete below and do not record more than ONE medication on same instance. Include all medications taken within 14 days, and all investigational drugs taken within 30 days (if investigational drug is administered within 30 days, please contact Medical Monitor [protocol violation]), prior to initiation of Argatroban infusion, and throughout study and 30- day follow-up period.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0549184
UMLS CUI [1,3]
C1511497
Is patient continuing on Argatroban treatment beyond the 14-day study period?
Description

If ‘Yes’, please include dosing in Continuous Infusion Section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0048470
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0231290
UMLS CUI [1,4]
C2347804
Concomintant Medications (Continuous Infusion)
Description

Concomintant Medications (Continuous Infusion)

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1511497
Drug Name of Administered IV
Description

(one drug per page) (Prefer Trade Name)

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C2347852
Drug Indication
Description

Concomitant continuous IV agent indication

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C3146298
Dose (include units)
Description

Concomitant continuous IV agent dose and dose unit

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C3174092
UMLS CUI [2,1]
C2826646
UMLS CUI [2,2]
C1511497
Rate (include units)
Description

Any changes in rate MUST be recorded as a new line entry.

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C2964135
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1511497
UMLS CUI [2,3]
C2964135
UMLS CUI [2,4]
C1519795
Start Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C0808070
Start Time
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C1301880
Stop Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C0806020
Stop Time
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C1522314
Check if ongoing at end of study
Description

Concomitant continous IV agent ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1511497
UMLS CUI [1,3]
C0444496
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Similar models

Concomitant Medications (Continuous Infusion)

1 forms
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])
Additional form
Item
Check if (additional) supplemental instance of this form was used.
boolean
C1706499 (UMLS CUI [1])
CRF Sequential Number
Item
Instance Number
integer
C1516308 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item Group
Concomintant Medications (Continuous Infusion)
C2347852 (UMLS CUI-1)
C1511497 (UMLS CUI-2)
No concomitant medications as continuous infusion
Item
Check if No Continuous Infusion Concomitant Medications were given:
boolean
C2347852 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
C1511497 (UMLS CUI [1,3])
Argatroban continued after study period end
Item
Is patient continuing on Argatroban treatment beyond the 14-day study period?
boolean
C0048470 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Item Group
Concomintant Medications (Continuous Infusion)
C2347852 (UMLS CUI-1)
C1511497 (UMLS CUI-2)
Concomitant continuous IV agent name
Item
Drug Name of Administered IV
text
C2360065 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Concomitant continuous IV agent indication
Item
Drug Indication
text
C2347852 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Concomitant continuous IV agent dose and dose unit
Item
Dose (include units)
text
C2347852 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2826646 (UMLS CUI [2,1])
C1511497 (UMLS CUI [2,2])
Concomitant continuous IV agent rate and rate unit
Item
Rate (include units)
text
C2347852 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C2964135 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2,1])
C1511497 (UMLS CUI [2,2])
C2964135 (UMLS CUI [2,3])
C1519795 (UMLS CUI [2,4])
Concomitant continuous IV agent start date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Concomitant continous IV agent start time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Concomitant continous IV agent stop date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Concomitant continuous IV agent stop time
Item
Stop Time
time
C2347852 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Concomitant continous IV agent ongoing
Item
Check if ongoing at end of study
boolean
C2826666 (UMLS CUI [1,1])
C1511497 (UMLS CUI [1,2])
C0444496 (UMLS CUI [1,3])
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