ID

41627

Descripción

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Palabras clave

Versiones (2)
  1. 21/11/20 21/11/20 -
  2. 29/11/20 29/11/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

29 de noviembre de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Inglés

New Thyroid Nodules

1 formularios  
  1. StudyEvent: ODM
    1. New Thyroid Nodules
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Site
Descripción

Site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Subject
Descripción

Subject

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Status
Descripción

Status

Tipo de datos

text

Alias
UMLS CUI [1]
C0449438
Doc#
Descripción

Doc#

Tipo de datos

integer

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Descripción

Is Page Blank?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
New Thyroid Nodules
Descripción

New Thyroid Nodules

Alias
UMLS CUI-1
C0040137
UMLS CUI-2
C0205314
Date of evaluation at which new nodule appeared:
Descripción

Date of evaluation at which new nodule appeared:

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
UMLS CUI [2,1]
C0040137
UMLS CUI [2,2]
C0205314
AE/SAE Reference Number
Descripción

AE/SAE Reference Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0237753
Solitary nodule or multinodular?
Descripción

Check

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0028259
UMLS CUI [1,2]
C0205171
UMLS CUI [2]
C0205416
Location
Descripción

Location

Tipo de datos

integer

Alias
UMLS CUI [1]
C0450429
Bidimensional Measurement 1
Descripción

Bidimensional Measurement 1

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0242485
UMLS CUI [2]
C1705052
cm
Bidimensional Measurement 2
Descripción

Bidimensional Measurement 2

Tipo de datos

float

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0242485
UMLS CUI [2]
C1705052
cm
Was an action taken?
Descripción

Was an action taken?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0441472
If action was taken, please check all that apply
Descripción

If action was taken, please check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1]
C1547656
UMLS CUI [2]
C2348235
If Diagnostic Method was Fine needle aspirate, please provide pathology results:
Descripción

(check only one)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0430022
UMLS CUI [2]
C1510483
UMLS CUI [3,1]
C0030664
UMLS CUI [3,2]
C1274040
Was an action taken due to fine needle aspirate pathology result?
Descripción

Was an action taken due to fine needle aspirate pathology result?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1510483
UMLS CUI [2,1]
C0030664
UMLS CUI [2,2]
C1274040
UMLS CUI [3]
C1547656
If action was taken due to fine needle aspirate pathology result, please provide details
Descripción

If action was taken due to fine needle aspirate pathology result, please provide details

Tipo de datos

text

Alias
UMLS CUI [1]
C1510483
UMLS CUI [2,1]
C0030664
UMLS CUI [2,2]
C1274040
UMLS CUI [3]
C1547656
UMLS CUI [4]
C1522508
Thyroid function
Descripción

Thyroid function

Alias
UMLS CUI-1
C0040130
Laboratory Test
Descripción

Laboratory Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0022885
Test Result
Descripción

Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C0587081
Unit
Descripción

Unit

Tipo de datos

text

Alias
UMLS CUI [1]
C1519795
LLN
Descripción

LLN

Tipo de datos

text

Alias
UMLS CUI [1]
C1518030
ULN
Descripción

ULN

Tipo de datos

text

Alias
UMLS CUI [1]
C1519815
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New Thyroid Nodules

1 formularios
  1. StudyEvent: ODM
    1. New Thyroid Nodules
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
New Thyroid Nodules
C0040137 (UMLS CUI-1)
C0205314 (UMLS CUI-2)
Date of evaluation at which new nodule appeared:
Item
Date of evaluation at which new nodule appeared:
date
C2985720 (UMLS CUI [1])
C0040137 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
AE/SAE Reference Number
Item
AE/SAE Reference Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Item
Solitary nodule or multinodular?
integer
C0028259 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0205416 (UMLS CUI [2])
Solitary nodule or multinodular?
Code List
Solitary nodule or multinodular?
CL Item
Solitary nodule (1)
CL Item
Multinodular (2)
Item
Location
integer
C0450429 (UMLS CUI [1])
Location
Code List
Location
CL Item
Right upper lobe (1)
CL Item
Left upper lobe (2)
CL Item
Right lower lobe (3)
CL Item
Left lower lobe (4)
CL Item
Isthmus (5)
Bidimensional Measurement 1
Item
Bidimensional Measurement 1
float
C0242485 (UMLS CUI [1])
C1705052 (UMLS CUI [2])
Bidimensional Measurement 2
Item
Bidimensional Measurement 2
float
C0242485 (UMLS CUI [1])
C1705052 (UMLS CUI [2])
Was an action taken?
Item
Was an action taken?
boolean
C0441472 (UMLS CUI [1])
Item
If action was taken, please check all that apply
integer
C1547656 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
If yes, specify action taken due to fine needle aspirate pathology result
Code List
If action was taken, please check all that apply
CL Item
Ultrasound (1)
CL Item
RIU (2)
CL Item
Technetium scan (3)
CL Item
Physical exam (4)
CL Item
Fine needle aspirate (5)
CL Item
Surgery (6)
CL Item
Thyroid function tests (7)
Item
If Diagnostic Method was Fine needle aspirate, please provide pathology results:
integer
C0430022 (UMLS CUI [1])
C1510483 (UMLS CUI [2])
C0030664 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
If Diagnostic Method was Fine needle aspirate, please provide pathology results:
Code List
If Diagnostic Method was Fine needle aspirate, please provide pathology results:
CL Item
Non-diagnostic (1)
CL Item
Benign (2)
CL Item
Malignant, thyroid cancer - Papillary (3)
CL Item
Malignant, thyroid cancer - Follicular (4)
CL Item
Malignant, thyroid cancer - Metastatic (5)
CL Item
Malignant, thyroid cancer - Medullary (6)
CL Item
Malignant, thyroid cancer - Aplastic (7)
Was an action taken due to fine needle aspirate pathology result?
Item
Was an action taken due to fine needle aspirate pathology result?
boolean
C1510483 (UMLS CUI [1])
C0030664 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
C1547656 (UMLS CUI [3])
If action was taken due to fine needle aspirate pathology result, please provide details
Item
If action was taken due to fine needle aspirate pathology result, please provide details
text
C1510483 (UMLS CUI [1])
C0030664 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
C1547656 (UMLS CUI [3])
C1522508 (UMLS CUI [4])
Item Group
Thyroid function
C0040130 (UMLS CUI-1)
Item
Laboratory Test
integer
C0022885 (UMLS CUI [1])
Laboratory Test
Code List
Laboratory Test
CL Item
Free T4 (1)
CL Item
T4 (2)
CL Item
TSH (3)
CL Item
Free T3 (4)
CL Item
T3 Uptake (5)
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
LLN
Item
LLN
text
C1518030 (UMLS CUI [1])
ULN
Item
ULN
text
C1519815 (UMLS CUI [1])
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