ID

28351

Description

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver imaging - Repeating form (Unscheduled/Dynamic visit)

Mots-clés

Versions (8)
  1. 11/10/2017 11/10/2017 -
  2. 16/10/2017 16/10/2017 -
  3. 23/10/2017 23/10/2017 -
  4. 05/01/2018 05/01/2018 -
  5. 10/01/2018 10/01/2018 -
  6. 10/01/2018 10/01/2018 -
  7. 16/06/2020 16/06/2020 -
  8. 17/06/2020 17/06/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

5 janvier 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

Anglais

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires  
Date of hepatic or liver imaging test
Description

Date of hepatic or liver imaging test

1. Date of hepatic or liver imaging test
Description

Date of hepatic or liver imaging test

Type de données

date

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0011008
What method was used for this imaging test?
Description

What method was used for this imaging test?

2. What method was used for this imaging test?
Description

method used for imaging test

Type de données

text

Alias
UMLS CUI [1]
C1275506
Other, specify:
Description

other method used for imaging test

Type de données

text

Alias
UMLS CUI [1]
C1275506
Are images technically adequate?
Description

Are images technically adequate?

3. Are images technically adequate?
Description

images technically adequate

Type de données

text

Alias
UMLS CUI [1]
C0806487
Other, specify:
Description

images technically adequate other

Type de données

text

Alias
UMLS CUI [1]
C0806487
Indicate the liver size
Description

Indicate the liver size

4. Indicate the liver size
Description

liver size

Type de données

text

Alias
UMLS CUI [1]
C0426688
Other, specify:
Description

other liver size

Type de données

text

Alias
UMLS CUI [1]
C0426688
Indicate the liver texture
Description

Indicate the liver texture

5. Indicate the liver texture
Description

liver texture

Type de données

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
Other, specify:
Description

other liver texture

Type de données

text

Alias
UMLS CUI [1,1]
C0426686
UMLS CUI [1,2]
C3845569
Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

Grade the diffuse and/or geographic fatty infiltrate of the liver

6. Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

diffuse and/or geographic fatty infiltrate of the liver

Type de données

text

Other, specify
Description

other grade of diffuse and/or geographic fatty infiltrate of the liver

Type de données

text

Ascites present
Description

Ascites present

7. Ascites present
Description

Ascites present

Type de données

text

Other, specify:
Description

ascites present other amount

Type de données

text

Are Focal Hepatic Lesions characterisable?
Description

Are Focal Hepatic Lesions characterisable?

8. Are Focal Hepatic Lesions characterisable?
Description

Focal Hepatic Lesions characterisable

Type de données

text

[E1] Solid
Description

Solid Focal Hepatic Lesions

Type de données

boolean

[E2] Cystic
Description

Cystic Focal Hepatic Lesions

Type de données

boolean

[E3] Hemangioma
Description

Hemangioma Focal Hepatic Lesions

Type de données

boolean

[E4] Focal Nodular Hyperplasia
Description

Focal Nodular Hyperplasia

Type de données

boolean

[E99] Other
Description

Other Focal Hepatic Lesions

Type de données

boolean

Other, specify:
Description

Other Focal Hepatic Lesions specification

Type de données

text

Gallstones or gallbladder lesions?
Description

Gallstones or gallbladder lesions?

9. Gallstones or gallbladder lesions?
Description

Gallstones or gallbladder lesions

Type de données

text

Alias
UMLS CUI [1]
C3842395
[F1] Gallstones
Description

Gallstones

Type de données

boolean

Alias
UMLS CUI [1]
C0008350
[F2] Gallbladder polyp(s)
Description

Gallbladder polyps

Type de données

boolean

Alias
UMLS CUI [1]
C0262493
[F3] Sludge
Description

Sludge

Type de données

boolean

Alias
UMLS CUI [1]
C0860209
[F4] Gallbladder wall thickening/oedema
Description

Gallbladder wall thickening/oedema

Type de données

boolean

Alias
UMLS CUI [1]
C0744257
[F5] Gallbladder wall gas
Description

Gallbladder wall gas

Type de données

boolean

Alias
UMLS CUI [1,1]
C2246573
UMLS CUI [1,2]
C0016976
[F6] Cholecystitis
Description

Cholecystitis

Type de données

boolean

Alias
UMLS CUI [1]
C0008325
[F7] Gallbladder wall calcification
Description

Gallbladder wall calcification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0016976
UMLS CUI [1,2]
C1533591
[F8] Gallbladder mass
Description

Gallbladder mass

Type de données

boolean

Alias
UMLS CUI [1]
C0016976
[F99] Other
Description

Other gallbladder lesions

Type de données

boolean

Alias
UMLS CUI [1]
C0156213
Other, specify
Description

Other gallbladder lesions specification

Type de données

text

Alias
UMLS CUI [1]
C0156213
Biliary ductal lesions?
Description

Biliary ductal lesions?

10. Biliary ductal lesions?
Description

Biliary ductal lesions

Type de données

text

[G1] Intrahepatic ductal dilation (focal involving the right hepatic lobe)
Description

Intrahepatic ductal dilation

Type de données

boolean

[G2] Intrahepatic ductal dilation (focal involving the left hepatic lobe)
Description

Intrahepatic ductal dilation

Type de données

boolean

[G4] Extrahepatic ductal dilation
Description

Extrahepatic ductal dilation

Type de données

boolean

[G5] Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
Description

Diffuse ductal dilation

Type de données

boolean

[G6] Acute Cholangitis
Description

Acute Cholangitis

Type de données

boolean

[G7] Primary sclerosing cholangitis
Description

Primary sclerosing cholangitis

Type de données

boolean

[G8] Choledocholithiasis (gallstone in duct)
Description

Choledocholithiasis

Type de données

boolean

[G9] Ductal filling defect(s), other than gallstone
Description

Ductal filling defect other than gallstone

Type de données

boolean

[G10] Ductal wall thickening or oedema
Description

Ductal wall thickening or oedema

Type de données

boolean

[G11] Choledochal cyst
Description

Choledochal cyst

Type de données

boolean

[G12] Ductal mass
Description

Ductal mass

Type de données

boolean

[G13] Extrinsic mass compressing bile duct(s)
Description

Extrinsic mass compressing bile duct

Type de données

boolean

[G99] Other
Description

Other Biliary ductal lesions

Type de données

boolean

Other, specify:
Description

Other Biliary ductal lesions specification

Type de données

text

Portal/Hepatic vein abnormalities?
Description

Portal/Hepatic vein abnormalities?

11. Portal/Hepatic vein abnormalities?
Description

Portal/Hepatic vein abnormalities?

Type de données

text

[H1] Portal vein enlargement
Description

Portal vein enlargement

Type de données

boolean

Alias
UMLS CUI [1]
C0155773
[H2] Hepatic vein enlargement
Description

Hepatic vein enlargement

Type de données

boolean

[H3] Nonocclusive portal vein thrombosis
Description

Nonocclusive portal vein thrombosis

Type de données

boolean

[H4] Occlusive portal vein thrombosis - bland
Description

Occlusive portal vein thrombosis - bland

Type de données

boolean

[H5] Hepatic vein thrombosis - bland
Description

Hepatic vein thrombosis - bland

Type de données

boolean

[H6] Occlusive portal vein thrombosis - malignant
Description

Occlusive portal vein thrombosis - malignant

Type de données

boolean

[H7] Hepatic vein thrombosis - malignant
Description

Hepatic vein thrombosis - malignant

Type de données

text

[H8] Involvement of the main portal vein
Description

Involvement of the main portal vein

Type de données

boolean

[H9] Involvement of the right portal vein
Description

Involvement of the right portal vein

Type de données

boolean

Alias
UMLS CUI [1]
C0155773
[H10] Involvement of the left portal vein
Description

Involvement of the left portal vein

Type de données

boolean

Alias
UMLS CUI [1]
C0155773
[H11] Budd-Chiari syndrome
Description

Budd-Chiari syndrome

Type de données

boolean

[H99] Other
Description

Other Portal/Hepatic vein abnormalities

Type de données

boolean

Other, specify:
Description

Other Portal/Hepatic vein abnormalities specification

Type de données

text

Retour au début de la page

Similar models

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Date of hepatic or liver imaging test
Date of hepatic or liver imaging test
Item
1. Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
What method was used for this imaging test?
Item
2. What method was used for this imaging test?
text
C1275506 (UMLS CUI [1])
method used for imaging test
Code List
2. What method was used for this imaging test?
CL Item
Ultrasound - transabdominal (1)
C2348813 (UMLS CUI-1)
(Comment:en)
CL Item
Ultrasound - endoscopic (2)
C0014245 (UMLS CUI-1)
(Comment:en)
CL Item
Magnetic Resonance Imaging (MRI) (3)
C0024485 (UMLS CUI-1)
(Comment:en)
CL Item
Computerised Tomography (CT) (4)
C1275400 (UMLS CUI-1)
(Comment:en)
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)
C0008310 (UMLS CUI-1)
(Comment:en)
CL Item
Positron Emission Tomography (PET) (6)
C0032743 (UMLS CUI-1)
(Comment:en)
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
C0032743 (UMLS CUI-1)
C0860888 (UMLS CUI-2)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
other method used for imaging test
Item
Other, specify:
text
C1275506 (UMLS CUI [1])
Item Group
Are images technically adequate?
Item
3. Are images technically adequate?
text
C0806487 (UMLS CUI [1])
images technically adequate
Code List
3. Are images technically adequate?
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other (OT)
images technically adequate other
Item
Other, specify:
text
C0806487 (UMLS CUI [1])
Item Group
Indicate the liver size
Item
4. Indicate the liver size
text
C0426688 (UMLS CUI [1])
liver size
Code List
4. Indicate the liver size
CL Item
Normal size (A1)
C0456389 (UMLS CUI-1)
(Comment:en)
CL Item
Hypertrophy (or enlarged) (A2)
C0020564 (UMLS CUI-1)
(Comment:en)
CL Item
Atrophy (or smaller than normal) (A3)
C0333641 (UMLS CUI-1)
(Comment:en)
CL Item
Segmental hypertrophy (A4)
C0020564 (UMLS CUI-1)
(Comment:en)
CL Item
Other (A99)
C0205394 (UMLS CUI-1)
(Comment:en)
other liver size
Item
Other, specify:
text
C0426688 (UMLS CUI [1])
Item Group
Indicate the liver texture
Item
5. Indicate the liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
liver texture
Code List
5. Indicate the liver texture
CL Item
Normal (B1)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Heterogenous (B2)
C1512426 (UMLS CUI-1)
(Comment:en)
CL Item
Suggestive of fibrosis (B3)
C0016059 (UMLS CUI-1)
(Comment:en)
CL Item
Nodular or suggestive of cirrhosis (B4)
C1334973 (UMLS CUI-1)
C0023890 (UMLS CUI-2)
(Comment:en)
CL Item
Other, (B99)
(Comment:en)
other liver texture
Item
Other, specify:
text
C0426686 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item Group
Grade the diffuse and/or geographic fatty infiltrate of the liver
Item
6. Grade the diffuse and/or geographic fatty infiltrate of the liver
text
diffuse and/or geographic fatty infiltrate of the liver
Code List
6. Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (C1)
CL Item
Mild (<=25%) (C2)
CL Item
Moderate (>25% to <75%) (C3)
CL Item
Severe (>=75%) (C4)
CL Item
Other (C99)
other grade of diffuse and/or geographic fatty infiltrate of the liver
Item
Other, specify
text
Item Group
Ascites present
Item
7. Ascites present
text
Ascites present
Code List
7. Ascites present
CL Item
None present (D1)
CL Item
Yes - small amount (D2)
CL Item
Yes - moderate or severe amount (D3)
CL Item
Other (D99)
ascites present other amount
Item
Other, specify:
text
Item Group
Are Focal Hepatic Lesions characterisable?
Item
8. Are Focal Hepatic Lesions characterisable?
text
Focal Hepatic Lesions characterisable
Code List
8. Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (E0)
CL Item
Check all that apply (E)
Solid Focal Hepatic Lesions
Item
[E1] Solid
boolean
Cystic Focal Hepatic Lesions
Item
[E2] Cystic
boolean
Hemangioma Focal Hepatic Lesions
Item
[E3] Hemangioma
boolean
Focal Nodular Hyperplasia
Item
[E4] Focal Nodular Hyperplasia
boolean
Other Focal Hepatic Lesions
Item
[E99] Other
boolean
Other Focal Hepatic Lesions specification
Item
Other, specify:
text
Item Group
Gallstones or gallbladder lesions?
Item
9. Gallstones or gallbladder lesions?
text
C3842395 (UMLS CUI [1])
Gallstones or gallbladder lesions
Code List
9. Gallstones or gallbladder lesions?
CL Item
None (F0)
CL Item
Check all that apply (F)
Gallstones
Item
[F1] Gallstones
boolean
C0008350 (UMLS CUI [1])
Gallbladder polyps
Item
[F2] Gallbladder polyp(s)
boolean
C0262493 (UMLS CUI [1])
Sludge
Item
[F3] Sludge
boolean
C0860209 (UMLS CUI [1])
Gallbladder wall thickening/oedema
Item
[F4] Gallbladder wall thickening/oedema
boolean
C0744257 (UMLS CUI [1])
Gallbladder wall gas
Item
[F5] Gallbladder wall gas
boolean
C2246573 (UMLS CUI [1,1])
C0016976 (UMLS CUI [1,2])
Cholecystitis
Item
[F6] Cholecystitis
boolean
C0008325 (UMLS CUI [1])
Gallbladder wall calcification
Item
[F7] Gallbladder wall calcification
boolean
C0016976 (UMLS CUI [1,1])
C1533591 (UMLS CUI [1,2])
Gallbladder mass
Item
[F8] Gallbladder mass
boolean
C0016976 (UMLS CUI [1])
Other gallbladder lesions
Item
[F99] Other
boolean
C0156213 (UMLS CUI [1])
Other gallbladder lesions specification
Item
Other, specify
text
C0156213 (UMLS CUI [1])
Item Group
Biliary ductal lesions?
Item
10. Biliary ductal lesions?
text
Biliary ductal lesions
Code List
10. Biliary ductal lesions?
CL Item
None (G0)
CL Item
Check all that apply (G)
Intrahepatic ductal dilation
Item
[G1] Intrahepatic ductal dilation (focal involving the right hepatic lobe)
boolean
Intrahepatic ductal dilation
Item
[G2] Intrahepatic ductal dilation (focal involving the left hepatic lobe)
boolean
Extrahepatic ductal dilation
Item
[G4] Extrahepatic ductal dilation
boolean
Diffuse ductal dilation
Item
[G5] Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
boolean
Acute Cholangitis
Item
[G6] Acute Cholangitis
boolean
Primary sclerosing cholangitis
Item
[G7] Primary sclerosing cholangitis
boolean
Choledocholithiasis
Item
[G8] Choledocholithiasis (gallstone in duct)
boolean
Ductal filling defect other than gallstone
Item
[G9] Ductal filling defect(s), other than gallstone
boolean
Ductal wall thickening or oedema
Item
[G10] Ductal wall thickening or oedema
boolean
Choledochal cyst
Item
[G11] Choledochal cyst
boolean
Ductal mass
Item
[G12] Ductal mass
boolean
Extrinsic mass compressing bile duct
Item
[G13] Extrinsic mass compressing bile duct(s)
boolean
Other Biliary ductal lesions
Item
[G99] Other
boolean
Other Biliary ductal lesions specification
Item
Other, specify:
text
Item Group
Portal/Hepatic vein abnormalities?
Item
11. Portal/Hepatic vein abnormalities?
text
Portal/Hepatic vein abnormalities?
Code List
11. Portal/Hepatic vein abnormalities?
CL Item
None (H0)
CL Item
Check all that apply (H)
Portal vein enlargement
Item
[H1] Portal vein enlargement
boolean
C0155773 (UMLS CUI [1])
Hepatic vein enlargement
Item
[H2] Hepatic vein enlargement
boolean
Nonocclusive portal vein thrombosis
Item
[H3] Nonocclusive portal vein thrombosis
boolean
Occlusive portal vein thrombosis - bland
Item
[H4] Occlusive portal vein thrombosis - bland
boolean
Hepatic vein thrombosis - bland
Item
[H5] Hepatic vein thrombosis - bland
boolean
Occlusive portal vein thrombosis - malignant
Item
[H6] Occlusive portal vein thrombosis - malignant
boolean
Hepatic vein thrombosis - malignant
Item
[H7] Hepatic vein thrombosis - malignant
text
Involvement of the main portal vein
Item
[H8] Involvement of the main portal vein
boolean
Involvement of the right portal vein
Item
[H9] Involvement of the right portal vein
boolean
C0155773 (UMLS CUI [1])
Involvement of the left portal vein
Item
[H10] Involvement of the left portal vein
boolean
C0155773 (UMLS CUI [1])
Budd-Chiari syndrome
Item
[H11] Budd-Chiari syndrome
boolean
Other Portal/Hepatic vein abnormalities
Item
[H99] Other
boolean
Other Portal/Hepatic vein abnormalities specification
Item
Other, specify:
text
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial