ID

26694

Beschreibung

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: Log status

Stichworte

Versionen (3)
  1. 24.09.17 24.09.17 -
  2. 23.10.17 23.10.17 -
  3. 26.12.17 26.12.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. Oktober 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Log status GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

Log status Chronic Coronary Heart Disease NCT00799903

1 Formulare  
Log status
Beschreibung

Log status

1. Did the subject experience any non-serious adverse events during the study?
Beschreibung

If yes, record details on Non-serious Adverse Event form. Per Section 6.4.6 of the protocol, non-serious AE collection will begin with the start of IP and continue until 35 days after the last dose of IP or the Follow Up Visit, whichever is longer.

Datentyp

boolean

2. Did the subject experience a serious adverse event during the study?
Beschreibung

Includes protocol-defined disease-related events/outcomes - MACE and secondary adjudicated events, and other study endpoints. If yes, record details on Serious Adverse Event form. Per protocol section 6.4.6, SAE collection begins with the start of IP and continues until 35 days after the last dose of IP or the Follow Up Visit, whichever is longer. However, SAEs assessed as related to IP, study participation (e.g., protocol-mandated procedures, invasive tests, or study related changes in existing therapy) or a GSK concomitant medication will be recorded from the time consent is signed through the end of the study. Per the endpoint reporting process, study endpoints will continue to be reported on the SAE-EP page through the end of the study.

Datentyp

boolean

3. Has the subject been diagnosed with new onset diabetes since the baseline visit?
Beschreibung

If yes, record details on New Onset Diabetes form, and the Non-Serious Adverse Event or Serious Adverse Event form, as appropriate. Report diagnosis of New Onset Diabetes from randomization through the end of the study, including subjects who have permanently discontinued IP.

Datentyp

boolean

4. Has the subject been diagnosed with new cancer, recurrence of cancer or metastatic cancer?
Beschreibung

If yes, record detail on Cancer Report form, and the Non-serious Adverse Event or Serious Adverse Event form, as appropriate. If yes, cancers should be reported as an SAE (or AE) as appropriate and along the same protocol defined reporting time period.

Datentyp

boolean

5. 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 randomisation?
Beschreibung

Report conditions diagnosed from time of randomisation until last study contact. If yes, record detail on Cancer/GI Neoplasm/Polyp Report form, and the Non-serious Adverse Event or Serious Adverse Event form, as appropriate

Datentyp

boolean

6. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since randomisation?
Beschreibung

Report procedures from time of randomisation until last study contact. If yes, record details on GI Procedures form

Datentyp

boolean

7. Did the subject experience a severe allergic reaction, anaphylaxis, or anaphylactoid event?
Beschreibung

If yes, complete the Anaphylaxis Diagnosis form If yes, complete the Anaphylaxis Diagnosis form. If the event meets the anaphylaxis criteria, then report as an SAE and along the same protocol defined reporting time period. If the event does not meet the anaphylaxis criteria, report as an AE/SAE as appropriate.

Datentyp

boolean

8. Were any cardiovascular diagnostic procedures performed?
Beschreibung

If yes, record details on Cardiovascular Diagnostic Procedures form Report any major cardiovascular procedures that are performed from randomization until 35 days after the last dose of IP or the Follow Up. Visit, whichever is longer. For subjects who permanently discontinue IP, only major cardiovascular procedures related to endpoints will continue to be collected until the end of the study.

Datentyp

boolean

Zum Seitenanfang zurückkehren

Ähnliche Modelle

Log status Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Log status
non-serious adverse events
Item
1. Did the subject experience any non-serious adverse events during the study?
boolean
serious adverse event
Item
2. Did the subject experience a serious adverse event during the study?
boolean
new onset diabetes daignosis
Item
3. Has the subject been diagnosed with new onset diabetes since the baseline visit?
boolean
cancer diagnosis
Item
4. Has the subject been diagnosed with new cancer, recurrence of cancer or metastatic cancer?
boolean
cancer diagnosis since randomozation
Item
5. 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 randomisation?
boolean
GI endoscopic procedures or GI capsule studies
Item
6. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since randomisation?
boolean
allergic reaction
Item
7. Did the subject experience a severe allergic reaction, anaphylaxis, or anaphylactoid event?
boolean
cardiovascular diagnostic procedures
Item
8. Were any cardiovascular diagnostic procedures performed?
boolean
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video