ID

28263

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: New Onset Diabetes Mellitus

Stichworte

Versionen (4)
  1. 27.09.17 27.09.17 -
  2. 13.10.17 13.10.17 -
  3. 23.10.17 23.10.17 -
  4. 01.01.18 01.01.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. Januar 2018

DOI

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Creative Commons BY-NC 3.0
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New Onset Diabetes Mellitus GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

New Onset Diabetes Mellitus GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
New Onset Diabetes Mellitus, Date of diagnosis
Beschreibung

New Onset Diabetes Mellitus, Date of diagnosis

1. Date of diagnosis
Beschreibung

Date of diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
2. Diagnosis based on fasting plasma glucose
Beschreibung

2. Diagnosis based on fasting plasma glucose

Diagnosis based on fasting plasma glucose >= 126 mg/dL (7 mmol/L)?
Beschreibung

Fasting is defined as no caloric intake for at least 8 hours

Datentyp

text

Alias
UMLS CUI [1]
C0583513
If yes, are FPG results available?
Beschreibung

FPG results available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0583513
UMLS CUI [1,2]
C0022885
IF FPG results available, record the results below
Beschreibung

Unit: mg/dL OR mmol/L

Datentyp

float

Unit FPG results
Beschreibung

Unit FPG results

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0583513
UMLS CUI [1,3]
C0022885
3. Diagnosis based on casual plasma glucose
Beschreibung

3. Diagnosis based on casual plasma glucose

New symptoms of diabetes?
Beschreibung

New symptoms of diabetes

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0011849
3. Diagnosis based on casual plasma glucose >= 200 mg/dL (11.1 mmol/L)?
Beschreibung

Casual is defined as any time of day without regard to time since last meal The classic symptoms of hyperglycaemia include polyuria, polydipsia, and unexplained weight loss

Datentyp

text

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0011900
If Yes, are casual plasma glucose results available?
Beschreibung

casual plasma glucose results available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0202042
UMLS CUI [1,4]
C0011900
If casual plasma glucose results available, record the results below
Beschreibung

Unit: mg/dL OR mmol/L

Datentyp

float

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0004076
Unit: plasma glucose results
Beschreibung

Unit plasma glucose results

Datentyp

text

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C1519795
4. Diagnosis based on an oral glucose tolerance test (OGTT)
Beschreibung

4. Diagnosis based on an oral glucose tolerance test (OGTT)

Diagnosis based on an oral glucose tolerance test (OGTT) 2-hour post load glucose >=200 mg/dL (11.1 mmol/L)?
Beschreibung

(The test should be performed as described by World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water)

Datentyp

text

Alias
UMLS CUI [1]
C0029161
If Yes, are OGTT results available?
Beschreibung

OGTT results available

Datentyp

boolean

Alias
UMLS CUI [1]
C0392201
If OGTT results available, record the results below
Beschreibung

Unit: mg/dL OR mmol/L

Datentyp

float

Unit: OGTT results
Beschreibung

Unit OGTT results

Datentyp

text

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C1519795
5. New anti-diabetic medication
Beschreibung

5. New anti-diabetic medication

Did the subject start new anti-diabetic medication?
Beschreibung

new anti-diabetic medication

Datentyp

text

Alias
UMLS CUI [1]
C0935929
6. HbA1c
Beschreibung

6. HbA1c

Did the subject have HbA1c >= 6.5%?
Beschreibung

HbA1c level

Datentyp

text

Alias
UMLS CUI [1]
C0019018
If Yes, are HbA1c results available?
Beschreibung

HbA1c results available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0456984
If HbA1c results available, record the results below
Beschreibung

HbA1c results

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C1274040
%
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Ähnliche Modelle

New Onset Diabetes Mellitus GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
New Onset Diabetes Mellitus, Date of diagnosis
Date of diagnosis
Item
1. Date of diagnosis
date
C2316983 (UMLS CUI [1])
Item Group
2. Diagnosis based on fasting plasma glucose
Item
Diagnosis based on fasting plasma glucose >= 126 mg/dL (7 mmol/L)?
text
C0583513 (UMLS CUI [1])
fasting plasma glucose
Code List
Diagnosis based on fasting plasma glucose >= 126 mg/dL (7 mmol/L)?
CL Item
Unknown (U)
CL Item
No (N)
CL Item
Yes (Y)
FPG results available
Item
If yes, are FPG results available?
boolean
C0583513 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
FPG results
Item
IF FPG results available, record the results below
float
Item
Unit FPG results
text
C1519795 (UMLS CUI [1,1])
C0583513 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Unit FPG results
Code List
Unit FPG results
CL Item
mg/dL (mg/dL)
C0439269 (UMLS CUI-1)
(Comment:en)
CL Item
mmol/L (mmol/L)
C1532563 (UMLS CUI-1)
(Comment:en)
Item Group
3. Diagnosis based on casual plasma glucose
Item
New symptoms of diabetes?
text
C0037088 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
New symptoms of diabetes
Code List
New symptoms of diabetes?
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
Item
3. Diagnosis based on casual plasma glucose >= 200 mg/dL (11.1 mmol/L)?
text
C0202042 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diagnosis based on casual plasma glucose
Code List
3. Diagnosis based on casual plasma glucose >= 200 mg/dL (11.1 mmol/L)?
CL Item
Unknown (U)
CL Item
Yes (Y)
CL Item
No (N)
casual plasma glucose results available
Item
If Yes, are casual plasma glucose results available?
boolean
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0202042 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
plasma glucose results
Item
If casual plasma glucose results available, record the results below
float
C0202042 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
Item
Unit: plasma glucose results
text
C0202042 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Unit plasma glucose results
Code List
Unit: plasma glucose results
CL Item
mg/dL (mg/dL)
C0439269 (UMLS CUI-1)
(Comment:en)
CL Item
mmol/L (mmol/L)
C1532563 (UMLS CUI-1)
(Comment:en)
Item Group
4. Diagnosis based on an oral glucose tolerance test (OGTT)
Item
Diagnosis based on an oral glucose tolerance test (OGTT) 2-hour post load glucose >=200 mg/dL (11.1 mmol/L)?
text
C0029161 (UMLS CUI [1])
fasting plasma glucose
Code List
Diagnosis based on an oral glucose tolerance test (OGTT) 2-hour post load glucose >=200 mg/dL (11.1 mmol/L)?
CL Item
Unknown (U)
CL Item
No (N)
CL Item
Yes (Y)
OGTT results available
Item
If Yes, are OGTT results available?
boolean
C0392201 (UMLS CUI [1])
OGTT results
Item
If OGTT results available, record the results below
float
Item
Unit: OGTT results
text
C0392201 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Unit: OGTT results
Code List
Unit: OGTT results
CL Item
mg/dL (mg/dL)
C0439269 (UMLS CUI-1)
(Comment:en)
CL Item
mmol/L (mmol/L)
C1532563 (UMLS CUI-1)
(Comment:en)
Item Group
5. New anti-diabetic medication
Item
Did the subject start new anti-diabetic medication?
text
C0935929 (UMLS CUI [1])
new anti-diabetic medication
Code List
Did the subject start new anti-diabetic medication?
CL Item
Unknown (U)
CL Item
Yes (record details of medication in the Concomitant Medication form) (Y)
CL Item
No (N)
Item Group
6. HbA1c
Item
Did the subject have HbA1c >= 6.5%?
text
C0019018 (UMLS CUI [1])
fasting plasma glucose
Code List
Did the subject have HbA1c >= 6.5%?
CL Item
Unknown (U)
CL Item
No (N)
CL Item
Yes (Y)
HbA1c results available
Item
If Yes, are HbA1c results available?
boolean
C0019018 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
HbA1c results
Item
If HbA1c results available, record the results below
float
C0019018 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
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