ID

33693

Beskrivning

Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01581658

Länk

https://clinicaltrials.gov/show/NCT01581658

Nyckelord

Versioner (1)
  1. 2018-12-19 2018-12-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 december 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Diabetes Mellitus, Type 2 NCT01581658

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT01581658

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes patients
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
glycosylated haemoglobin>= 6.1% (japan diabetes society)
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 ml/min/1.73m2
Beskrivning

GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C2170215
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any evidence of significant disease (other than renal impairment)
Beskrivning

Disease Significant | Exception Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1565489
moderate and severe concurrent liver function impairment
Beskrivning

Liver Dysfunction Moderate | Liver Dysfunction Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
gastrointestinal tract surgery, that might affect absorption and elimination of drugs
Beskrivning

Gastrointestinal Surgical Procedure Affecting Drug absorption | Gastrointestinal Surgical Procedure Affecting Drug elimination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524722
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683141
diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
Beskrivning

CNS disorder | Epilepsy | Mental disorders | Nervous system disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0027765
chronic or relevant acute infections
Beskrivning

Chronic infectious disease | Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0009450
participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
Tillbaka till toppen

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01581658

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes patients
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin>= 6.1% (japan diabetes society)
boolean
C0474680 (UMLS CUI [1])
GFR estimation by MDRD
Item
estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 ml/min/1.73m2
boolean
C2170215 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Significant | Exception Renal Insufficiency
Item
any evidence of significant disease (other than renal impairment)
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1565489 (UMLS CUI [2,2])
Liver Dysfunction Moderate | Liver Dysfunction Severe
Item
moderate and severe concurrent liver function impairment
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Gastrointestinal Surgical Procedure Affecting Drug absorption | Gastrointestinal Surgical Procedure Affecting Drug elimination
Item
gastrointestinal tract surgery, that might affect absorption and elimination of drugs
boolean
C0524722 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683141 (UMLS CUI [2,3])
CNS disorder | Epilepsy | Mental disorders | Nervous system disorder
Item
diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
Chronic infectious disease | Communicable Diseases
Item
chronic or relevant acute infections
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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