ID

41475

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 Adverse Events Form has to be filled in each time such Event occurs during the Study. Please use one Instance of this Form for every 12 Records.

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

Adverse Events

1 forms  
  1. StudyEvent: ODM
    1. Adverse Events
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

Use one instance for every 12 records of adverse events. 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
Did the patient experience any AEs?
Description

Did the patient experience any AEs?

Alias
UMLS CUI-1
C0877248
Did the patient experience any AEs?
Description

If Yes, please complete below.

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Line #
Description

Use a new instance if more than 12 lines are required.

Data type

integer

Alias
UMLS CUI [1]
C2348184
Adverse Events
Description

(List all events during the study - including 30-day follow-up period)

Data type

text

Alias
UMLS CUI [1]
C0877248
Start Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
Start Time
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1301880
Stop Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
Stop Time
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1522314
Action Taken: 0 = None
Description

(List all Applicable)

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
UMLS CUI [1,3]
C0549184
Action Taken: 1 = Drug discontinued
Description

(List all Applicable)

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
UMLS CUI [2]
C0558681
Action Taken: 2 = Drug dose adjusted
Description

(List all Applicable)

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
UMLS CUI [2]
C2826232
Action Taken: 3 = Drug interrupted
Description

(List all Applicable)

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1512900
Action Taken: 4 = Therapy required
Description

(List all Applicable) (record on Concomitant Medications form)

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0087111
Outcome
Description

Adverse event outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Relationship to Study Drug
Description

Adverse event relationship to study drug

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Severity
Description

Adverse event severity

Data type

integer

Alias
UMLS CUI [1]
C1710066
Was Event Serious?
Description

*Serious event requires SAE page, AND must be reported via fax to GSK within 24 hours at

Data type

text

Alias
UMLS CUI [1]
C1710056
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Similar models

Adverse Events

1 forms
  1. StudyEvent: ODM
    1. Adverse Events
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
Did the patient experience any AEs?
C0877248 (UMLS CUI-1)
Item
Did the patient experience any AEs?
text
C0877248 (UMLS CUI [1])
Adverse Events
Code List
Did the patient experience any AEs?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Sequence number
Item
Line #
integer
C2348184 (UMLS CUI [1])
Adverse event
Item
Adverse Events
text
C0877248 (UMLS CUI [1])
Adverse event start date
Item
Start Date
date
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Adverse event start time
Item
Start Time
time
C0877248 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Adverse event stop date
Item
Stop Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Adverse event stop time
Item
Stop Time
time
C0877248 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Action taken with study treatment because of adverse event - none
Item
Action Taken: 0 = None
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
Action taken with study treatment because of adverse event - drug discontinued
Item
Action Taken: 1 = Drug discontinued
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0558681 (UMLS CUI [2])
Action taken with study treatment because of adverse event - drug dose adjusted
Item
Action Taken: 2 = Drug dose adjusted
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C2826232 (UMLS CUI [2])
Action taken with study treatment because of adverse event - drug interrupted
Item
Action Taken: 3 = Drug interrupted
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
Action taken with study treatment because of adverse event - Therapy required
Item
Action Taken: 4 = Therapy required
boolean
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Adverse event outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Resolved with sequelae (2)
CL Item
Ongoing (3)
CL Item
Death / fatal (4)
CL Item
Unknown (5)
Item
Relationship to Study Drug
integer
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Adverse event relationship to study drug
Code List
Relationship to Study Drug
CL Item
Definite (1)
CL Item
Probable (2)
CL Item
Possible (3)
CL Item
Unlikely (4)
CL Item
Unrelated (5)
Item
Severity
integer
C1710066 (UMLS CUI [1])
Adverse event severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Was Event Serious?
text
C1710056 (UMLS CUI [1])
SAE
Code List
Was Event Serious?
CL Item
Yes (Yes)
CL Item
No (No)
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