ID

26260

Descrição

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)

Palavras-chave

Versões (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 -
Titular dos direitos

GlaxoSmithKline

Transferido a

13 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

Inglês

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários  
GI procedures performed post-randomization form
Descrição

GI procedures performed post-randomization form

1. Date of procedure(s)
Descrição

Date of procedure

Tipo de dados

date

GI procedures entry
Descrição

GI procedures entry

2.a GI Procedure
Descrição

GI Procedure

Tipo de dados

text

If other GI endoscopic procedure, specify:
Descrição

Other GI endoscopic procedure specification

Tipo de dados

text

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

Tick all that apply

Tipo de dados

boolean

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

Tick all that apply

Tipo de dados

boolean

2.b Reason for GI procedure: [3] Procedure for surveillance for family history of colorectal cancer
Descrição

Tick all that apply

Tipo de dados

boolean

2.b Reason for GI procedure: [4] Procedure that was prompted by blood in stool or evidence of GI bleeding (upper or lower)
Descrição

Tick all that apply

Tipo de dados

boolean

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

Tick all that apply

Tipo de dados

boolean

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

Tick all that apply

Tipo de dados

boolean

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

Tick all that apply

Tipo de dados

boolean

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

Tick all that apply

Tipo de dados

boolean

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

Tick all that apply

Tipo de dados

boolean

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

Tick all that apply

Tipo de dados

boolean

2.b Reason for GI procedure: [OT] Procedure that was precipitated by other symptom or finding
Descrição

Tick all that apply

Tipo de dados

boolean

2.b Reason for GI procedure: If Procedure that was precipitated by other symptom or finding, specify
Descrição

Tick all that apply

Tipo de dados

text

3. Was a cancer identified?
Descrição

cancer identified

Tipo de dados

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?
Descrição

1=neoplastic or non-neoplastic

Tipo de dados

text

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Similar models

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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