ID

41351

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 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 Post-Treatment Physical Exam Form is used to record the physical examination prior to initiation of treatment. For patients receiving Argatroban for no more than 14 days, complete within 24 hours of final infusion completion. For patients receiving Argatroban for more than 14 days [continuing with non-study Argatroban], complete within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.

Link

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

Stichworte

Versionen (1)
  1. 03.09.20 03.09.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

3. September 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

Post-Treatment Physical Exam

1 Formulare  
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
Date:
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Time:
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Vital Signs
Beschreibung

Vital Signs

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

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (Diastolic):
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Respiration:
Beschreibung

Respiratory Rate

Datentyp

integer

Maßeinheiten
  • per min.
Alias
UMLS CUI [1]
C0231832
per min.
Height:
Beschreibung

Body Height

Datentyp

float

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

Body Height Unit

Datentyp

text

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

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature:
Beschreibung

Body Temperature

Datentyp

float

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

Body Temperature Unit

Datentyp

text

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

Body Weight

Datentyp

float

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

Body Weight Unit

Datentyp

text

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

Pre-treatment Physical Exam

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

Physical Examination: General Appearance - status

Datentyp

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C0449438
General Appearance - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C0443172
Skin
Beschreibung

Physical Examination: Skin - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0437750
UMLS CUI [1,2]
C0449438
Skin - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0437750
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C0443172
Head/Neck
Beschreibung

Physical Examination: Head/Neck - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C0449438
Head/Neck - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0460004
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Lymph Nodes
Beschreibung

Physical Examination: Lymph Nodes - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C0449438
Lymph Nodes - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Breasts
Beschreibung

Physical Examination: Breasts - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
UMLS CUI [1,3]
C0449438
Breasts - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Heart
Beschreibung

Physical Examination: Heart - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0449438
Heart - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Lungs
Beschreibung

Physical Examination: Lungs - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
UMLS CUI [1,3]
C0449438
Lungs - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Abdomen
Beschreibung

Physical Examination: Abdomen - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C0449438
Abdomen - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Genitalia
Beschreibung

Physical Examination: Genitalia - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0017420
UMLS CUI [1,3]
C0449438
Genitalia - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0017420
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Extremities
Beschreibung

Physical Examination: Extremities - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0449438
Extremities - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Neurologic
Beschreibung

Physical Examination: Neurologic - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C0449438
Neurologic - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0027853
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Rectal
Beschreibung

Physical Examination: Rectal - status

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
UMLS CUI [1,3]
C0449438
Rectal - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199900
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
UMLS CUI [1,5]
C0443172
Other
Beschreibung

Physical Examination: Other - status

Datentyp

text

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

Specify body system

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
Other
Beschreibung

Physical Examination: Other - status

Datentyp

text

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

Specify body system

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other - If Change from Pre-Treatment Exam, Describe Change:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
UMLS CUI [1,4]
C0443172
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Ähnliche Modelle

Post-Treatment Physical Exam

1 Formulare
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])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: General Appearance - specify status change
Item
General Appearance - If Change from Pre-Treatment Exam, Describe Change:
text
C1148438 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Item
Skin
text
C0437750 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Physical Examination: General Appearance
Code List
Skin
CL Item
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Skin - specify status change
Item
Skin - If Change from Pre-Treatment Exam, Describe Change:
text
C0437750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Head/Neck - specify status change
Item
Head/Neck - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Lymph Nodes - specify status change
Item
Lymph Nodes - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Breasts - specify status change
Item
Breasts - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Heart - specify status change
Item
Heart - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Lungs - specify status change
Item
Lungs - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Abdomen - specify status change
Item
Abdomen - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Genitalia - specify status change
Item
Genitalia - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0017420 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Extremities - specify status change
Item
Extremities - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Neurologic - specify status change
Item
Neurologic - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
Physical Examination: Rectal - specify status change
Item
Rectal - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0443172 (UMLS CUI [1,5])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
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 status change
Item
Other - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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
No Change (No Change)
CL Item
Check if Change from Pre-Treatment Exam (Check if Change from Pre-Treatment Exam)
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 status change
Item
Other - If Change from Pre-Treatment Exam, Describe Change:
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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