ID

28175

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: Log status

Keywords

Versions (3)
  1. 9/24/17 9/24/17 -
  2. 10/23/17 10/23/17 -
  3. 12/26/17 12/26/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 26, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Log status GSK study Chronic Coronary Heart Disease NCT00799903

English

Log status Chronic Coronary Heart Disease NCT00799903

1 forms  
Log status
Description

Log status

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

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.

Data type

boolean

Alias
UMLS CUI [1]
C1518404
2. Did the subject experience a serious adverse event during the study?
Description

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.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
3. Has the subject been diagnosed with new onset diabetes since the baseline visit?
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0746890
UMLS CUI [1,2]
C0011849
4. Has the subject been diagnosed with new cancer, recurrence of cancer or metastatic cancer?
Description

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.

Data type

boolean

Alias
UMLS CUI [1]
C0920688
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?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0920688
6. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since randomisation?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0947979
7. Did the subject experience a severe allergic reaction, anaphylaxis, or anaphylactoid event?
Description

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.

Data type

boolean

Alias
UMLS CUI [1]
C1527304
8. Were any cardiovascular diagnostic procedures performed?
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0007226
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Similar models

Log status Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Log status
non-serious adverse events
Item
1. Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse event
Item
2. Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
new onset diabetes daignosis
Item
3. Has the subject been diagnosed with new onset diabetes since the baseline visit?
boolean
C0746890 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
cancer diagnosis
Item
4. Has the subject been diagnosed with new cancer, recurrence of cancer or metastatic cancer?
boolean
C0920688 (UMLS CUI [1])
cancer diagnosis since randomization
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
C0034656 (UMLS CUI [1,1])
C0920688 (UMLS CUI [1,2])
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
C0947979 (UMLS CUI [1])
allergic reaction
Item
7. Did the subject experience a severe allergic reaction, anaphylaxis, or anaphylactoid event?
boolean
C1527304 (UMLS CUI [1])
cardiovascular diagnostic procedures
Item
8. Were any cardiovascular diagnostic procedures performed?
boolean
C0430022 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
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