ID

26697

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: Hospitalisation - Repeating form (Scheduled visits)

Stichworte

Versionen (4)
  1. 27.09.17 27.09.17 -
  2. 04.10.17 04.10.17 -
  3. 23.10.17 23.10.17 -
  4. 01.01.18 01.01.18 -
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.

Hospitalisation Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

Eligibility Chronic Kidney Disease NCT01003275

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
estimated glomerular filtration rate of 15-59 ml/min/1.73m2
Beschreibung

Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C3811844
fasting glucose 100-125 mg/dl
Beschreibung

Glucose measurement, fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0202045
18 years and older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosed with diabetes mellitus
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
use of diabetes medications (insulin or oral hypoglycemics)
Beschreibung

Taking medication for diabetes | Insulin | Oral hypoglycemic

Datentyp

boolean

Alias
UMLS CUI [1]
C2054148
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0359086
prior dialysis or transplantation
Beschreibung

Dialysis | Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0040732
planning to leave the area within 6 months
Beschreibung

Relocation of home Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
participation in another clinical trial within 30 days
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
Beschreibung

paricalcitol | Calcitriol | Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0249582
UMLS CUI [2]
C0006674
UMLS CUI [3]
C0001617
serum calcium more than 10.2 mg/dl
Beschreibung

Serum calcium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0728876
pregnancy or breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
change in dose (within 8 weeks) of fibrates, niacin, ace inhibitors, angiotensin receptor blockers, thiazide diuretics, beta-blockers, cholecalciferol or ergocalciferol
Beschreibung

Fibrates Dose changed | Niacin Dose changed | Angiotensin-Converting Enzyme Inhibitors Dose changed | Angiotensin II receptor antagonist Dose changed | Thiazide Diuretics Dose changed | Adrenergic beta-Antagonists Dose changed | Cholecalciferol Dose changed | Ergocalciferol Dose changed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1449704
UMLS CUI [1,2]
C1608430
UMLS CUI [2,1]
C0027996
UMLS CUI [2,2]
C1608430
UMLS CUI [3,1]
C0003015
UMLS CUI [3,2]
C1608430
UMLS CUI [4,1]
C0521942
UMLS CUI [4,2]
C1608430
UMLS CUI [5,1]
C0012802
UMLS CUI [5,2]
C1608430
UMLS CUI [6,1]
C0001645
UMLS CUI [6,2]
C1608430
UMLS CUI [7,1]
C0008318
UMLS CUI [7,2]
C1608430
UMLS CUI [8,1]
C0014695
UMLS CUI [8,2]
C1608430
incontinent of urine
Beschreibung

Urinary Incontinence

Datentyp

boolean

Alias
UMLS CUI [1]
C0042024
cancer (other than skin cancer) within 5 years
Beschreibung

Malignant Neoplasms | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
tuberculosis
Beschreibung

Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0041296
sarcoidosis
Beschreibung

Sarcoidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0036202
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Chronic Kidney Disease NCT01003275

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate of 15-59 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose 100-125 mg/dl
boolean
C0202045 (UMLS CUI [1])
Age
Item
18 years and older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
diagnosed with diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Taking medication for diabetes | Insulin | Oral hypoglycemic
Item
use of diabetes medications (insulin or oral hypoglycemics)
boolean
C2054148 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0359086 (UMLS CUI [3])
Dialysis | Transplantation
Item
prior dialysis or transplantation
boolean
C0011946 (UMLS CUI [1])
C0040732 (UMLS CUI [2])
Relocation of home Planned
Item
planning to leave the area within 6 months
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in another clinical trial within 30 days
boolean
C2348568 (UMLS CUI [1])
paricalcitol | Calcitriol | Adrenal Cortex Hormones
Item
treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
boolean
C0249582 (UMLS CUI [1])
C0006674 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
Serum calcium measurement
Item
serum calcium more than 10.2 mg/dl
boolean
C0728876 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Fibrates Dose changed | Niacin Dose changed | Angiotensin-Converting Enzyme Inhibitors Dose changed | Angiotensin II receptor antagonist Dose changed | Thiazide Diuretics Dose changed | Adrenergic beta-Antagonists Dose changed | Cholecalciferol Dose changed | Ergocalciferol Dose changed
Item
change in dose (within 8 weeks) of fibrates, niacin, ace inhibitors, angiotensin receptor blockers, thiazide diuretics, beta-blockers, cholecalciferol or ergocalciferol
boolean
C1449704 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
C0027996 (UMLS CUI [2,1])
C1608430 (UMLS CUI [2,2])
C0003015 (UMLS CUI [3,1])
C1608430 (UMLS CUI [3,2])
C0521942 (UMLS CUI [4,1])
C1608430 (UMLS CUI [4,2])
C0012802 (UMLS CUI [5,1])
C1608430 (UMLS CUI [5,2])
C0001645 (UMLS CUI [6,1])
C1608430 (UMLS CUI [6,2])
C0008318 (UMLS CUI [7,1])
C1608430 (UMLS CUI [7,2])
C0014695 (UMLS CUI [8,1])
C1608430 (UMLS CUI [8,2])
Urinary Incontinence
Item
incontinent of urine
boolean
C0042024 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma
Item
cancer (other than skin cancer) within 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Tuberculosis
Item
tuberculosis
boolean
C0041296 (UMLS CUI [1])
Sarcoidosis
Item
sarcoidosis
boolean
C0036202 (UMLS CUI [1])
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