ID

26028

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

4 octobre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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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

GI procedures entry
Description

GI procedures entry

2.a GI Procedure
Description

GI Procedure

Type de données

text

If other GI endoscopic procedure, specify:
Description

Other GI endoscopic procedure specification

Type de données

text

2.b Reason for GI procedure: [1] Routine screening study
Description

Tick all that apply

Type de données

boolean

2.b Reason for GI procedure: [2] Procedure for surveillance for Barrett's esophagus
Description

Tick all that apply

Type de données

boolean

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

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

2.b Reason for GI procedure: [5] Procedure that was prompted by anemia
Description

Tick all that apply

Type de données

boolean

2.b Reason for GI procedure: [6] Procedure that was prompted by difficulty swallowing
Description

Tick all that apply

Type de données

boolean

2.b Reason for GI procedure: [7] Procedure that was prompted by esophageal reflux
Description

Tick all that apply

Type de données

boolean

2.b Reason for GI procedure: [8] Procedure that was prompted by diarrhoea
Description

Tick all that apply

Type de données

boolean

2.b Reason for GI procedure: [9] Procedure that was prompted by abdominal pain
Description

Tick all that apply

Type de données

boolean

2.b Reason for GI procedure: [UNK] Unknown
Description

Tick all that apply

Type de données

boolean

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

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

3. Was a cancer identified?
Description

cancer identified

Type de données

text

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

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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
Item Group
GI procedures entry
Item
2.a GI Procedure
text
GI Procedure
Code List
2.a GI Procedure
CL Item
Upper endoscopy (1)
CL Item
Capsule endoscopy (2)
CL Item
Push enteroscopy (3)
CL Item
Colonoscopy (4)
CL Item
Sigmoidoscopy only (5)
CL Item
Other GI endoscopic procedure (specify) (OT)
Other GI endoscopic procedure specification
Item
If other GI endoscopic procedure, specify:
text
Routine screening study
Item
2.b Reason for GI procedure: [1] Routine screening study
boolean
surveillance for Barrett's esophagus
Item
2.b Reason for GI procedure: [2] Procedure for surveillance for Barrett's esophagus
boolean
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
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
anemia
Item
2.b Reason for GI procedure: [5] Procedure that was prompted by anemia
boolean
difficulty swallowing
Item
2.b Reason for GI procedure: [6] Procedure that was prompted by difficulty swallowing
boolean
esophageal reflux
Item
2.b Reason for GI procedure: [7] Procedure that was prompted by esophageal reflux
boolean
diarrhoea
Item
2.b Reason for GI procedure: [8] Procedure that was prompted by diarrhoea
boolean
abdominal pain
Item
2.b Reason for GI procedure: [9] Procedure that was prompted by abdominal pain
boolean
Reason for GI procedure unknown
Item
2.b Reason for GI procedure: [UNK] Unknown
boolean
other symptom or finding
Item
2.b Reason for GI procedure: [OT] Procedure that was precipitated by other symptom or finding
boolean
other symptom or finding specification
Item
2.b Reason for GI procedure: If Procedure that was precipitated by other symptom or finding, specify
text
Item
3. Was a cancer identified?
text
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
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)
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