ID

41481

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 This Form has to be filled in at the Followup Visit. It records Vital Signs, changes from the Post-Treatment Exam and (re)occurence of specified Events.

Link

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

Stichworte

Versionen (1)
  1. 24.10.20 24.10.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. Oktober 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

30-Day Followup (+/- 14 Days)

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
Followup Visit
Beschreibung

Followup Visit

Alias
UMLS CUI-1
C0589121
Was telephone contact substituted for visit?
Beschreibung

Telephone call replacing visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0545082
Date of follow-up:
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1]
C3694716
Time:
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0040223
Vital Signs
Beschreibung

Vital Signs

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

Blood pressure - systolic

Datentyp

integer

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

Blood pressure - diastolic

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.
Heart Rate:
Beschreibung

Heart rate

Datentyp

text

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

Body temperature

Datentyp

float

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

Body temperature unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
System Code
Beschreibung

Body system examined

Datentyp

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0031809
Description of Change
Beschreibung

(one per line)

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C0443172
No Change
Beschreibung

No change in physical examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442739
UMLS CUI [1,2]
C0031809
Please mark all events that occurred during dosing:
Beschreibung

Please mark all events that occurred during dosing:

Alias
UMLS CUI-1
C2347784
(or None: please check this box)
Beschreibung

If None, check this Box and leave the following fields blank.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347784
UMLS CUI [1,2]
C0549184
Venous thrombosis
Beschreibung

Venous thrombosis

Datentyp

text

Alias
UMLS CUI [1]
C0042487
Venous thrombosis - specify location:
Beschreibung

Venous thrombosis - location

Datentyp

text

Alias
UMLS CUI [1,1]
C0042487
UMLS CUI [1,2]
C0450429
Venous thrombosis - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0042487
UMLS CUI [1,2]
C0011008
Pulmonary embolus
Beschreibung

Pulmonary embolus

Datentyp

text

Alias
UMLS CUI [1]
C0034065
Pulmonary embolus - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0011008
Arterial thrombosis
Beschreibung

Arterial thrombosis

Datentyp

text

Alias
UMLS CUI [1]
C0151942
Arterial thrombosis - specify location:
Beschreibung

Arterial thrombosis - location

Datentyp

text

Alias
UMLS CUI [1,1]
C0151942
UMLS CUI [1,2]
C0450429
Arterial thrombosis - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0151942
UMLS CUI [1,2]
C0011008
Clotting in any external circuit that requires immediate therapeutic intervention
Beschreibung

Clotting in external circuit that requires immediate intervention

Datentyp

text

Alias
UMLS CUI [1]
C0949072
UMLS CUI [2,1]
C1708545
UMLS CUI [2,2]
C0205253
Clotting in any external circuit that requires immediate therapeutic intervention - specify circuit location:
Beschreibung

Clotting in external circuit that requires immediate intervention - specify circuit location

Datentyp

text

Alias
UMLS CUI [1]
C0949072
UMLS CUI [2,1]
C1708545
UMLS CUI [2,2]
C0205253
UMLS CUI [3,1]
C2348235
UMLS CUI [3,2]
C0015354
Clotting in any external circuit that requires immediate therapeutic intervention - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1]
C0949072
UMLS CUI [2,1]
C1708545
UMLS CUI [2,2]
C0205253
UMLS CUI [3]
C0011008
Death due to thromboembolic complication
Beschreibung

Death due to thromboembolic complication

Datentyp

text

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C0040038
UMLS CUI [1,3]
C0009566
Death due to thromboembolic complication - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C1705232
UMLS CUI [1,2]
C0040038
UMLS CUI [1,3]
C0009566
UMLS CUI [1,4]
C1148348
Amputation due to thromboembolic complication
Beschreibung

Amputation due to thromboembolic complication

Datentyp

text

Alias
UMLS CUI [1,1]
C0002688
UMLS CUI [1,2]
C0040038
UMLS CUI [1,3]
C0009566
Amputation due to thromboembolic complication - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0002688
UMLS CUI [1,2]
C0040038
UMLS CUI [1,3]
C0009566
UMLS CUI [1,4]
C0011008
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Ähnliche Modelle

30-Day Followup (+/- 14 Days)

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])
Item Group
Followup Visit
C0589121 (UMLS CUI-1)
Item
Was telephone contact substituted for visit?
text
C0302186 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Telephone call replacing visit
Code List
Was telephone contact substituted for visit?
CL Item
Yes (Yes)
CL Item
No (No)
Follow-up visit date
Item
Date of follow-up:
date
C3694716 (UMLS CUI [1])
Follow-up visit time
Item
Time:
time
C0589121 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Blood pressure - systolic
Item
Blood Pressure: Systolic:
integer
C0871470 (UMLS CUI [1])
Blood pressure - diastolic
Item
Blood Pressure: Diastolic:
integer
C0428883 (UMLS CUI [1])
Respiratory rate
Item
Respiration:
integer
C0231832 (UMLS CUI [1])
Heart rate
Item
Heart Rate:
text
C0018810 (UMLS CUI [1])
Body temperature
Item
Temperature:
float
C0005903 (UMLS CUI [1])
Item
Temperature: Unit:
text
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body temperature unit
Code List
Temperature: Unit:
CL Item
°F (°F)
CL Item
°C (°C)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
System Code
integer
C0460002 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Body system examined
Code List
System Code
CL Item
General Appearance (1)
CL Item
Skin (2)
CL Item
Head and Neck  (3)
CL Item
Lymph Nodes (4)
CL Item
Breasts  (5)
CL Item
Heart  (6)
CL Item
Lungs  (7)
CL Item
Abdomen  (8)
CL Item
Genitalia  (9)
CL Item
Extremities  (10)
CL Item
Neurologic (11)
CL Item
Rectal (12)
CL Item
Other, specify (13)
Description of change in physical examination
Item
Description of Change
text
C0031809 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
No change in physical examination
Item
No Change
boolean
C0442739 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Item Group
Please mark all events that occurred during dosing:
C2347784 (UMLS CUI-1)
No clinical endpoints met
Item
(or None: please check this box)
boolean
C2347784 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Item
Venous thrombosis
text
C0042487 (UMLS CUI [1])
Telephone call replacing visit
Code List
Venous thrombosis
CL Item
Yes (Yes)
CL Item
No (No)
Venous thrombosis - location
Item
Venous thrombosis - specify location:
text
C0042487 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Venous thrombosis - date
Item
Venous thrombosis - Date
date
C0042487 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pulmonary embolus
text
C0034065 (UMLS CUI [1])
Telephone call replacing visit
Code List
Pulmonary embolus
CL Item
Yes (Yes)
CL Item
No (No)
Pulmonary embolus - date
Item
Pulmonary embolus - Date
date
C0034065 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Arterial thrombosis
text
C0151942 (UMLS CUI [1])
Telephone call replacing visit
Code List
Arterial thrombosis
CL Item
Yes (Yes)
CL Item
No (No)
Arterial thrombosis - location
Item
Arterial thrombosis - specify location:
text
C0151942 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Arterial thrombosis - date
Item
Arterial thrombosis - Date
date
C0151942 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Clotting in any external circuit that requires immediate therapeutic intervention
text
C0949072 (UMLS CUI [1])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
Telephone call replacing visit
Code List
Clotting in any external circuit that requires immediate therapeutic intervention
CL Item
Yes (Yes)
CL Item
No (No)
Clotting in external circuit that requires immediate intervention - specify circuit location
Item
Clotting in any external circuit that requires immediate therapeutic intervention - specify circuit location:
text
C0949072 (UMLS CUI [1])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3,1])
C0015354 (UMLS CUI [3,2])
Clotting in external circuit that requires immediate intervention - date
Item
Clotting in any external circuit that requires immediate therapeutic intervention - Date
date
C0949072 (UMLS CUI [1])
C1708545 (UMLS CUI [2,1])
C0205253 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Death due to thromboembolic complication
text
C1705232 (UMLS CUI [1,1])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
Telephone call replacing visit
Code List
Death due to thromboembolic complication
CL Item
Yes (Yes)
CL Item
No (No)
Death due to thromboembolic complication - date
Item
Death due to thromboembolic complication - Date
date
C1705232 (UMLS CUI [1,1])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C1148348 (UMLS CUI [1,4])
Item
Amputation due to thromboembolic complication
text
C0002688 (UMLS CUI [1,1])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
Telephone call replacing visit
Code List
Amputation due to thromboembolic complication
CL Item
Yes (Yes)
CL Item
No (No)
Amputation due to thromboembolic complication - date
Item
Amputation due to thromboembolic complication - Date
date
C0002688 (UMLS CUI [1,1])
C0040038 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
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