Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

Subject status and major events
Descripción

Subject status and major events

1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
Descripción

Yes - complete SAE and MI or ANG endpoint form

Tipo de datos

text

2. Has the subject experienced a stroke / TIA event since the last visit?
Descripción

Yes - complete SAE and Stroke/TIA endpoint form

Tipo de datos

text

3. Has the subject been hospitalized for heart failure since the last visit?
Descripción

Yes - complete SAE and Hospitalisation for Heart Failure endpoint form

Tipo de datos

text

4. Has the subject undergone a coronary revascularisation since the last visit?
Descripción

Yes - complete SAE and Revascularisation endpoint form

Tipo de datos

text

5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
Descripción

Yes - complete SAE and Other Endpoint form

Tipo de datos

text

6. Has the subject undergone a non-coronary revascularisation since the last visit?
Descripción

Yes - complete SAE and Other Endpoint form

Tipo de datos

text

7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
Descripción

Yes - complete SAE and Other Endpoint form

Tipo de datos

text

8. Has the subject been diagnosed with new onset diabetes since the last visit?
Descripción

Yes - record details on New Onset Diabetes form, and the Non-Serious Adverse Event or Serious Adverse Event form, as appropriate

Tipo de datos

text

9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
Descripción

Yes - record details on Cancer/GI Neoplasm/Polyp Report form and the Non-Serious Adverse Event or Serious Adverse Event form, as appropriate

Tipo de datos

text

10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
Descripción

Yes - complete the GI procedures form. Note: If question is being asked for the first time please report GI endoscopic procedure(s) that have been performed from randomization visit until this visit. If question has already been answered at an earlier visit then only refer back to the last time this question was asked.

Tipo de datos

text

11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
Descripción

Yes - record details on the Cardiovascular Diagnostic Procedures form

Tipo de datos

text

12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
Descripción

Yes - complete Serious Adverse Event form

Tipo de datos

text

Similar models

Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Subject status and major events
Item
1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
text
Code List
1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
2. Has the subject experienced a stroke / TIA event since the last visit?
text
Code List
2. Has the subject experienced a stroke / TIA event since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
3. Has the subject been hospitalized for heart failure since the last visit?
text
Code List
3. Has the subject been hospitalized for heart failure since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
4. Has the subject undergone a coronary revascularisation since the last visit?
text
Code List
4. Has the subject undergone a coronary revascularisation since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
text
Code List
5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
6. Has the subject undergone a non-coronary revascularisation since the last visit?
text
Code List
6. Has the subject undergone a non-coronary revascularisation since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
text
Code List
7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
8. Has the subject been diagnosed with new onset diabetes since the last visit?
text
Code List
8. Has the subject been diagnosed with new onset diabetes since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
text
Code List
9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
text
Code List
10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
text
Code List
11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)
Item
12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
text
Code List
12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Question not asked (Z)