ID

20063

Description

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Mots-clés

  1. 31/12/2016 31/12/2016 -
  2. 04/02/2017 04/02/2017 -
Téléchargé le

4 février 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Screen Failure Log: Screening Failure [SF_1] NCT01117584

Screen Failure Log: Screening Failure [SF_1] NCT01117584

General Information
Description

General Information

Birth Date
Description

Birth Date

Type de données

date

Alias
UMLS CUI [1]
C0421451
Age
Description

Age

Type de données

integer

Alias
UMLS CUI [1]
C0001779
Age Unit
Description

Age Unit

Type de données

boolean

Sex
Description

Sex

Type de données

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Type de données

text

Alias
UMLS CUI [1]
C0034510
If Other, please specify
Description

Other

Type de données

text

Ethnicity
Description

Ethnicity

Type de données

text

Alias
UMLS CUI [1]
C0015031
Reason for not meeting admission criteria
Description

Reason for not meeting admission criteria

Type de données

text

Alias
UMLS CUI [1,1]
C0582450
UMLS CUI [1,2]
C0243161
If Other, please specify
Description

Other

Type de données

text

FPG > 270 mg/dL on 2 consecutive measurements
Description

If Reason is "Not meet inclusion/exclusion criteria", select all that apply

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
FPG > 350 mg/dL
Description

FPG > 350 mg/dL

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
FPG < 40 mg/dL
Description

FPG < 40 mg/dL

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
Other Inclusion/Exclusion Criteria Not Met, please specify
Description

Specification

Type de données

text

Alias
UMLS CUI [1,1]
C0680252
UMLS CUI [1,2]
C0243161

Similar models

Screen Failure Log: Screening Failure [SF_1] NCT01117584

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
General Information
Birth Date
Item
Birth Date
date
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Age Unit
Item
Age Unit
boolean
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
White (1)
CL Item
Black or African American (2)
CL Item
Asian (3)
CL Item
Amerikan Indian or Alaska Native (4)
CL Item
Native Hawaiian or Other Pacific Islander (5)
CL Item
Other (6)
Other
Item
If Other, please specify
text
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
Not Hispanic or Latino (1)
CL Item
Hispanic or Latino (2)
Item
Reason for not meeting admission criteria
text
C0582450 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Code List
Reason for not meeting admission criteria
CL Item
Not fulfill inclusion or exclusion criteria (1)
CL Item
Adverse Event (2)
CL Item
Withdrawal of consent  (3)
CL Item
Subject lost to follow up (4)
CL Item
Other (5)
Other
Item
If Other, please specify
text
FPG > 270 mg/dL on 2 consecutive measurements
Item
FPG > 270 mg/dL on 2 consecutive measurements
boolean
C0583513 (UMLS CUI [1])
FPG > 350 mg/dL
Item
FPG > 350 mg/dL
boolean
C0583513 (UMLS CUI [1])
FPG < 40 mg/dL
Item
FPG < 40 mg/dL
boolean
C0583513 (UMLS CUI [1])
Specification
Item
Other Inclusion/Exclusion Criteria Not Met, please specify
text
C0680252 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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