ID

28272

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: GI procedured report form - Repeating form (Scheduled visits)

Mots-clés

Versions (4)
  1. 04/10/2017 04/10/2017 -
  2. 13/10/2017 13/10/2017 -
  3. 23/10/2017 23/10/2017 -
  4. 01/01/2018 01/01/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

1 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.

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

Anglais

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires  
GI procedures performed post-randomization form
Description

GI procedures performed post-randomization form

1. Date of procedure(s)
Description

Date of procedure

Type de données

date

Alias
UMLS CUI [1]
C2584899
GI procedures entry
Description

GI procedures entry

2.a GI Procedure
Description

GI Procedure

Type de données

text

Alias
UMLS CUI [1]
C0524722
If other GI endoscopic procedure, specify:
Description

Other GI endoscopic procedure specification

Type de données

text

Alias
UMLS CUI [1]
C0393107
2.b Reason for GI procedure: [1] Routine screening study
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C3842345
2.b Reason for GI procedure: [2] Procedure for surveillance for Barrett's esophagus
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C1333324
2.b Reason for GI procedure: [3] Procedure for surveillance for family history of colorectal cancer
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C3266797
2.b Reason for GI procedure: [4] Procedure that was prompted by blood in stool or evidence of GI bleeding (upper or lower)
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C0017181
2.b Reason for GI procedure: [5] Procedure that was prompted by anemia
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C0002871
2.b Reason for GI procedure: [6] Procedure that was prompted by difficulty swallowing
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C4084787
2.b Reason for GI procedure: [7] Procedure that was prompted by esophageal reflux
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C0232483
2.b Reason for GI procedure: [8] Procedure that was prompted by diarrhoea
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C0011991
2.b Reason for GI procedure: [9] Procedure that was prompted by abdominal pain
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C0000737
2.b Reason for GI procedure: [UNK] Unknown
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C3258099
2.b Reason for GI procedure: [OT] Procedure that was precipitated by other symptom or finding
Description

Tick all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C1335151
2.b Reason for GI procedure: If Procedure that was precipitated by other symptom or finding, specify
Description

Tick all that apply

Type de données

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2826279
UMLS CUI [1,3]
C2348235
3. Was a cancer identified?
Description

cancer identified

Type de données

text

Alias
UMLS CUI [1]
C0006826
4. Was a benign GI polyp(s) (1), a benign GI neoplasms(s) or a neoplasm(s) unable to be determined as benign or malignant identified?
Description

1=neoplastic or non-neoplastic

Type de données

text

Alias
UMLS CUI [1]
C3843757
Retour au début de la page

Similar models

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
GI procedures performed post-randomization form
Date of procedure
Item
1. Date of procedure(s)
date
C2584899 (UMLS CUI [1])
Item Group
GI procedures entry
Item
2.a GI Procedure
text
C0524722 (UMLS CUI [1])
GI Procedure
Code List
2.a GI Procedure
CL Item
Upper endoscopy (1)
C0438280 (UMLS CUI-1)
(Comment:en)
CL Item
Capsule endoscopy (2)
C1721048 (UMLS CUI-1)
(Comment:en)
CL Item
Push enteroscopy (3)
C2936452 (UMLS CUI-1)
(Comment:en)
CL Item
Colonoscopy (4)
C0009378 (UMLS CUI-1)
(Comment:en)
CL Item
Sigmoidoscopy only (5)
C0037075 (UMLS CUI-1)
(Comment:en)
CL Item
Other GI endoscopic procedure (specify) (OT)
C0393107 (UMLS CUI-1)
(Comment:en)
Other GI endoscopic procedure specification
Item
If other GI endoscopic procedure, specify:
text
C0393107 (UMLS CUI [1])
Routine screening study
Item
2.b Reason for GI procedure: [1] Routine screening study
boolean
C3842345 (UMLS CUI [1])
surveillance for Barrett's esophagus
Item
2.b Reason for GI procedure: [2] Procedure for surveillance for Barrett's esophagus
boolean
C1333324 (UMLS CUI [1])
surveillance for family history of colorectal cancer
Item
2.b Reason for GI procedure: [3] Procedure for surveillance for family history of colorectal cancer
boolean
C3266797 (UMLS CUI [1])
blood in stool or evidence of GI bleeding
Item
2.b Reason for GI procedure: [4] Procedure that was prompted by blood in stool or evidence of GI bleeding (upper or lower)
boolean
C0017181 (UMLS CUI [1])
anemia
Item
2.b Reason for GI procedure: [5] Procedure that was prompted by anemia
boolean
C0002871 (UMLS CUI [1])
difficulty swallowing
Item
2.b Reason for GI procedure: [6] Procedure that was prompted by difficulty swallowing
boolean
C4084787 (UMLS CUI [1])
esophageal reflux
Item
2.b Reason for GI procedure: [7] Procedure that was prompted by esophageal reflux
boolean
C0232483 (UMLS CUI [1])
Diarrhea
Item
2.b Reason for GI procedure: [8] Procedure that was prompted by diarrhoea
boolean
C0011991 (UMLS CUI [1])
abdominal pain
Item
2.b Reason for GI procedure: [9] Procedure that was prompted by abdominal pain
boolean
C0000737 (UMLS CUI [1])
Reason for GI procedure unknown
Item
2.b Reason for GI procedure: [UNK] Unknown
boolean
C3258099 (UMLS CUI [1])
other symptom or finding
Item
2.b Reason for GI procedure: [OT] Procedure that was precipitated by other symptom or finding
boolean
C1335151 (UMLS CUI [1])
other symptom or finding specification
Item
2.b Reason for GI procedure: If Procedure that was precipitated by other symptom or finding, specify
text
C1515974 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
3. Was a cancer identified?
text
C0006826 (UMLS CUI [1])
cancer identified
Code List
3. Was a cancer identified?
CL Item
No (confirmed by procedure/pathology report) (N)
CL Item
Yes, please complete the cancer/GI neoplasm/polyp form and report as an AE/SAE as appropriate (Y)
CL Item
Unknown (U)
Item
4. Was a benign GI polyp(s) (1), a benign GI neoplasms(s) or a neoplasm(s) unable to be determined as benign or malignant identified?
text
C3843757 (UMLS CUI [1])
cancer identified
Code List
4. Was a benign GI polyp(s) (1), a benign GI neoplasms(s) or a neoplasm(s) unable to be determined as benign or malignant identified?
CL Item
No (confirmed by procedure/pathology report) (N)
CL Item
Yes, please complete the cancer/GI neoplasm/polyp form and report as an AE/SAE as appropriate (Y)
CL Item
Unknown (U)
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