ID

41627

Description

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

Keywords

Versions (2)
  1. 11/21/20 11/21/20 -
  2. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

DOI

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License

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

English

New Thyroid Nodules

1 forms  
  1. StudyEvent: ODM
    1. New Thyroid Nodules
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Subject

Data type

text

Alias
UMLS CUI [1]
C2348585
Status
Description

Status

Data type

text

Alias
UMLS CUI [1]
C0449438
Doc#
Description

Doc#

Data type

integer

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

Is Page Blank?

Data type

boolean

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

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
New Thyroid Nodules
Description

New Thyroid Nodules

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

Date of evaluation at which new nodule appeared:

Data type

date

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

AE/SAE Reference Number

Data type

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?
Description

Check

Data type

integer

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

Location

Data type

integer

Alias
UMLS CUI [1]
C0450429
Bidimensional Measurement 1
Description

Bidimensional Measurement 1

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0242485
UMLS CUI [2]
C1705052
cm
Bidimensional Measurement 2
Description

Bidimensional Measurement 2

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0242485
UMLS CUI [2]
C1705052
cm
Was an action taken?
Description

Was an action taken?

Data type

boolean

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

If action was taken, please check all that apply

Data type

integer

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

(check only one)

Data type

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?
Description

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

Data type

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
Description

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

Data type

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
Description

Thyroid function

Alias
UMLS CUI-1
C0040130
Laboratory Test
Description

Laboratory Test

Data type

integer

Alias
UMLS CUI [1]
C0022885
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C1519795
LLN
Description

LLN

Data type

text

Alias
UMLS CUI [1]
C1518030
ULN
Description

ULN

Data type

text

Alias
UMLS CUI [1]
C1519815
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Similar models

New Thyroid Nodules

1 forms
  1. StudyEvent: ODM
    1. New Thyroid Nodules
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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