ID

41349

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 The Pre-Treatment Physical Exam Form has to be filled in at the screening visit. It is used to record the physical examination prior to initiation of treatment. To be completed within 72 hours before treatment initiation.

Link

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

Keywords

Versions (1)
  1. 9/3/20 9/3/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 3, 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

Pre-Treatment Physical Exam

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
Date:
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1]
C1320303
Time:
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1]
C0040223
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Blood Pressure (Systolic):
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (Diastolic):
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Respiration:
Description

Respiratory Rate

Data type

integer

Measurement units
  • per min.
Alias
UMLS CUI [1]
C0231832
per min.
Height:
Description

Body Height

Data type

float

Alias
UMLS CUI [1]
C0005890
Height - Unit:
Description

Body Height Unit

Data type

text

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C1519795
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature:
Description

Body Temperature

Data type

float

Alias
UMLS CUI [1]
C0005903
Body Temperature - Unit:
Description

Body Temperature Unit

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Weight:
Description

Body Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Weight - Unit:
Description

Body Weight Unit

Data type

text

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
Pre-treatment Physical Exam
Description

Pre-treatment Physical Exam

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C2709094
General Appearance
Description

Physical Examination: General Appearance - status

Data type

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C0449438
General Appearance - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C1521902
Skin
Description

Physical Examination: Skin - status

Data type

text

Alias
UMLS CUI [1,1]
C0437750
UMLS CUI [1,2]
C0449438
Skin - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0437750
UMLS CUI [1,2]
C1521902
Head/Neck
Description

Physical Examination: Head/Neck - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C0449438
Head/Neck - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C1521902
Lymph Nodes
Description

Physical Examination: Lymph Nodes - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C0449438
Lymph Nodes - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C1521902
Breasts
Description

Physical Examination: Breasts - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
UMLS CUI [1,3]
C0449438
Breasts - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
UMLS CUI [1,3]
C1521902
Heart
Description

Physical Examination: Heart - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0449438
Heart - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C1521902
Lungs
Description

Physical Examination: Lungs - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
UMLS CUI [1,3]
C0449438
Lungs - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
UMLS CUI [1,3]
C1521902
Abdomen
Description

Physical Examination: Abdomen - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C0449438
Abdomen - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1521902
Genitalia
Description

Physical Examination: Genitalia - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0017420
UMLS CUI [1,3]
C0449438
Genitalia - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0017420
UMLS CUI [1,3]
C1521902
Extremities
Description

Physical Examination: Extremities - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0449438
Extremities - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521902
Neurologic
Description

Physical Examination: Neurologic - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C0449438
Neurologic - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C1521902
Rectal
Description

Physical Examination: Rectal - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
UMLS CUI [1,3]
C0449438
Rectal - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
UMLS CUI [1,3]
C1521902
Other
Description

Physical Examination: Other - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449438
Other - specify:
Description

Specify body system

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other
Description

Physical Examination: Other - status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449438
Other - specify:
Description

Specify body system

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other - Abnormal, specify:
Description

(abnormality should associate with Medical History, see Medical History Form)

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
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Similar models

Pre-Treatment Physical Exam

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])
Date
Item
Date:
date
C1320303 (UMLS CUI [1])
Time
Item
Time:
time
C0040223 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Systolic Blood Pressure
Item
Blood Pressure (Systolic):
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure (Diastolic):
integer
C0428883 (UMLS CUI [1])
Respiratory Rate
Item
Respiration:
integer
C0231832 (UMLS CUI [1])
Body Height
Item
Height:
float
C0005890 (UMLS CUI [1])
Item
Height - Unit:
text
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Height Unit
Code List
Height - Unit:
CL Item
inches (inches)
CL Item
cm (cm)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature:
float
C0005903 (UMLS CUI [1])
Item
Body Temperature - Unit:
text
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Temperature Unit
Code List
Body Temperature - Unit:
CL Item
°F (°F)
CL Item
°C (°C)
Body Weight
Item
Weight:
float
C0005910 (UMLS CUI [1])
Item
Weight - Unit:
text
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Weight Unit
Code List
Weight - Unit:
CL Item
lbs (lbs)
CL Item
kg (kg)
Item Group
Pre-treatment Physical Exam
C0031809 (UMLS CUI-1)
C2709094 (UMLS CUI-2)
Item
General Appearance
text
C1148438 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Physical Examination: General Appearance
Code List
General Appearance
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: General Appearance - specify
Item
General Appearance - Abnormal, specify:
text
C1148438 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Skin
text
C0437750 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Physical Examination: General Appearance
Code List
Skin
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Skin - specify
Item
Skin - Abnormal, specify:
text
C0437750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Head/Neck
text
C0031809 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Head/Neck
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Head/Neck - specify
Item
Head/Neck - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Lymph Nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Lymph Nodes
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Lymph Nodes - specify
Item
Lymph Nodes - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Breasts
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Breasts - specify
Item
Breasts - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Heart
text
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Heart
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Heart - specify
Item
Heart - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Lungs
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Lungs
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Lungs - specify
Item
Lungs - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Abdomen
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Abdomen - specify
Item
Abdomen - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Genitalia
text
C0031809 (UMLS CUI [1,1])
C0017420 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Genitalia
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Genitalia - specify
Item
Genitalia - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0017420 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Extremities
text
C0031809 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Extremities
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Extremities - specify
Item
Extremities - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Neurologic
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Neurologic
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Neurologic - specify
Item
Neurologic - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Rectal
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Rectal
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Rectal - specify
Item
Rectal - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Other
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Other
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Other - specify
Item
Other - specify:
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Physical Examination: Other - specify
Item
Other - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Other
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Physical Examination: General Appearance
Code List
Other
CL Item
Normal (Normal)
CL Item
Abnormal, specify: (Abnormal, specify:)
Physical Examination: Other - specify
Item
Other - specify:
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Physical Examination: Other - specify
Item
Other - Abnormal, specify:
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
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