ID

26358

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: Subject status and major events

Palavras-chave

Versões (4)
  1. 12/10/17 12/10/17 -
  2. 16/10/17 16/10/17 -
  3. 23/10/17 23/10/17 -
  4. 2/1/18 2/1/18 -
Titular dos direitos

GlaxoSmithKline

Transferido a

16 de octubre de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

  • Os mais recentes
  • Os mais antigos
  • Preferidos
  • Os mais recentes
    • Os mais recentes
    • Os mais antigos
    • Preferidos

Sem comentários

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

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

Inglês

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

1 Formulários  
Subject status and major events
Descrição

Subject status and major events

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

Yes - complete SAE and MI or ANG endpoint form

Tipo de dados

text

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

Yes - complete SAE and Stroke/TIA endpoint form

Tipo de dados

text

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

Yes - complete SAE and Hospitalisation for Heart Failure endpoint form

Tipo de dados

text

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

Yes - complete SAE and Revascularisation endpoint form

Tipo de dados

text

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

Yes - complete SAE and Other Endpoint form

Tipo de dados

text

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

Yes - complete SAE and Other Endpoint form

Tipo de dados

text

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

Yes - complete SAE and Other Endpoint form

Tipo de dados

text

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

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

Tipo de dados

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?
Descrição

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 dados

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?
Descrição

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 dados

text

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

Yes - record details on the Cardiovascular Diagnostic Procedures form

Tipo de dados

text

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

Yes - complete Serious Adverse Event form

Tipo de dados

text

Voltar ao início da página

Similar models

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

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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
cardiac endpoint event
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)
Voltar ao início da página 

Ajuda

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