ID

41466

Beschreibung

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 Bleeding Record has to be filled in whenever any bleeding occurs during the Study.

Link

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

Stichworte

Versionen (1)
  1. 20/10/2020 20/10/2020 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20 de outubro de 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

Englisch

Bleeding Record

1 Formulare  
  1. StudyEvent: ODM
    1. Bleeding Record
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Beschreibung

Study centre number

Datentyp

integer

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

patient ID

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Beschreibung

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Check if (additional) supplemental instance of this form was used.
Beschreibung

Use one instance for every seven records of bleeding events. Check this box on all instances except for the last one.

Datentyp

boolean

Alias
UMLS CUI [1]
C1706499
Instance Number
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C2348184
Did the patient experience any bleeding?
Beschreibung

Did the patient experience any bleeding?

Alias
UMLS CUI-1
C0019080
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
Did the patient experience any bleeding?
Beschreibung

If Yes, please complete below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Bleeding Record
Beschreibung

Bleeding Record

Alias
UMLS CUI-1
C0019080
Bleeding Site Code
Beschreibung

Bleeding site

Datentyp

integer

Alias
UMLS CUI [1]
C3258161
Comments
Beschreibung

Comment - bleeding

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0019080
Bleeding Event Onset Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0574845
Onset Time
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1301880
Bleeding Event Stop Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0806020
Stop Time
Beschreibung

(0000-2359)

Datentyp

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1522314
Severity
Beschreibung

Per protocol:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0439793
Action Taken: 0 = None
Beschreibung

(List all Applicable)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0549184
Action Taken: 1 = Pressure
Beschreibung

(List all Applicable)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0019080
UMLS CUI [2]
C0728907
Action Taken: 2 = Study Drug Discontinued
Beschreibung

(List all Applicable)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0019080
UMLS CUI [2,1]
C0457454
UMLS CUI [2,2]
C0304229
Action Taken: 3 = Transfusion
Beschreibung

(List all Applicable) Record on Transfusion Record Form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0019080
UMLS CUI [2]
C1879316
Action Taken: 4 = Study Drug Decreased
Beschreibung

(List all Applicable)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0019080
UMLS CUI [2,1]
C0850891
UMLS CUI [2,2]
C0304229
Action Taken: 5 = Other, specify on Comments Form
Beschreibung

(List all Applicable)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0205394
Relation to Study Drug
Beschreibung

Relation of bleeding to study drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0869014
UMLS CUI [1,3]
C0019080
Was Event Serious?
Beschreibung

If Yes: Serious event requires SAE page, AND must be reported via fax to GSK within 24 hours at CENSORED.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0871902
Was This a Major Bleed?
Beschreibung

Major Bleeding Definition: Bleeding will be classified as major if one or more of the following pertain: • If it is overt and associated with a fall in the hemoglobin level of 2 grams/dL or more, • if it is retroperitoneal, • if it is intracranial.

Datentyp

integer

Alias
UMLS CUI [1]
C3160769
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Ähnliche Modelle

Bleeding Record

1 Formulare
  1. StudyEvent: ODM
    1. Bleeding Record
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 bleeding?
C0019080 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Bleeding during clinical trial
Item
Did the patient experience any bleeding?
boolean
C0019080 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Bleeding Record
C0019080 (UMLS CUI-1)
Item
Bleeding Site Code
integer
C3258161 (UMLS CUI [1])
Bleeding site
Code List
Bleeding Site Code
CL Item
Groin (1)
CL Item
Brachial or Radial (2)
CL Item
Hgb and/or Hct drop only (3)
CL Item
Retroperitoneal (4)
CL Item
Spontaneous gross hematuria (5)
CL Item
Oral (6)
CL Item
Spontaneous hematemesis (7)
CL Item
GI (8)
CL Item
GU (9)
CL Item
Cardiac surgery (10)
CL Item
Intracranial (11)
CL Item
Otic (12)
CL Item
Epistaxis (13)
CL Item
Hemoptysis (14)
CL Item
Optic (15)
CL Item
Other (specify in Comments field) (16)
Comment - bleeding
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
Bleeding event onset date
Item
Bleeding Event Onset Date
date
C0019080 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Bleeeding event onset time
Item
Onset Time
time
C0019080 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Bleeding event stop date
Item
Bleeding Event Stop Date
date
C0019080 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Bleeding event stop time
Item
Stop Time
text
C0019080 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Severity
integer
C0019080 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Bleeding severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Action taken to stop bleeding: none
Item
Action Taken: 0 = None
boolean
C1547656 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
Action taken to stop bleeding: pressure
Item
Action Taken: 1 = Pressure
boolean
C1547656 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0728907 (UMLS CUI [2])
Action taken to stop bleeding: study drug discontinuation
Item
Action Taken: 2 = Study Drug Discontinued
boolean
C1547656 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Action taken to stop bleeding: transfusion
Item
Action Taken: 3 = Transfusion
boolean
C1547656 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1879316 (UMLS CUI [2])
Action taken to stop bleeding: decrease of study drug dosage
Item
Action Taken: 4 = Study Drug Decreased
boolean
C1547656 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0850891 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Action taken to stop bleeding: other
Item
Action Taken: 5 = Other, specify on Comments Form
boolean
C1547656 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Relation to Study Drug
integer
C0013227 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
Relation of bleeding to study drug
Code List
Relation to Study Drug
CL Item
Almost certainly (1)
CL Item
Probably (2)
CL Item
Possibly (3)
CL Item
Unlikely (4)
CL Item
Unrelated (5)
Item
Was Event Serious?
integer
C0019080 (UMLS CUI [1,1])
C0871902 (UMLS CUI [1,2])
Seriousness of bleeding
Code List
Was Event Serious?
CL Item
Yes (1)
CL Item
No (2)
Item
Was This a Major Bleed?
integer
C3160769 (UMLS CUI [1])
Seriousness of bleeding
Code List
Was This a Major Bleed?
CL Item
Yes (1)
CL Item
No (2)
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