Informações:
Falhas:
ID
41628
Descrição
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
Palavras-chave
Versões (2)
- 19/11/2020 19/11/2020 -
- 29/11/2020 29/11/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
29 de novembro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Similar models
Pancreatitis
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
AE/SAE Number
Item
AE/SAE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Pancreatitis - Date of Onset:
Item
Pancreatitis - Date of Onset:
date
C0030305 (UMLS CUI [1])
C0574845 (UMLS CUI [2])
C0574845 (UMLS CUI [2])
Item
Was alcohol consumed on a regular basis?
integer
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,2])
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
If Yes, record the average number of units consumed daily:
Item
If Yes, record the average number of units consumed daily:
integer
C0560578 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,2])
Item Group
Family History of Pancreatitis
C0030305 (UMLS CUI-1)
C0241889 (UMLS CUI-2)
C0241889 (UMLS CUI-2)
Is there a family history of Pancreatitis?
Item
Is there a family history of Pancreatitis?
boolean
C0030305 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
Item Group
Family History of Pancreatitis
C0030305 (UMLS CUI-1)
C0241889 (UMLS CUI-2)
C0241889 (UMLS CUI-2)
CL Item
Grandmother (maternal) (1)
CL Item
Grandfather (maternal) (2)
CL Item
Grandmother (paternal) (3)
CL Item
Grandfather (paternal) (4)
CL Item
Mother (5)
CL Item
Father (6)
CL Item
Sibling (7)
CL Item
Other (8)
If sibling, specify
Item
If sibling, specify
text
C0037047 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
C2348235 (UMLS CUI [2])
If other family member, specify
Item
If other family member, specify
text
C0086282 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item Group
Pancreatitis - Recent trauma/vascular invasive procedures or surgery
C0030305 (UMLS CUI-1)
C3714660 (UMLS CUI-2)
C0042381 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
C3714660 (UMLS CUI-2)
C0042381 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
Recent trauma/vascular invasive procedures or surgery
Item
Recent trauma/vascular invasive procedures or surgery
text
C3714660 (UMLS CUI [1,1])
C0042381 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0042381 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of Recent Trauma/Invasive Procedure
Item
Date of Recent Trauma/Invasive Procedure
date
C3714660 (UMLS CUI [1,1])
C1548804 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1548804 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Symptoms of gastrointestinal illness associated with pancreatitis
C1457887 (UMLS CUI-1)
C0521362 (UMLS CUI-2)
C0221423 (UMLS CUI-3)
C0030305 (UMLS CUI-4)
C0521362 (UMLS CUI-2)
C0221423 (UMLS CUI-3)
C0030305 (UMLS CUI-4)
CL Item
Epigastrium (1)
CL Item
Periumbilical region (2)
CL Item
Right upper quadrant (3)
CL Item
Left upper quadrant (4)
CL Item
Right lower quadrant (5)
CL Item
Left lower quadrant (6)
CL Item
Right flank (7)
CL Item
Left flank (8)
CL Item
Back (9)
CL Item
Other (10)
Specify other pain
Item
Specify other pain
text
C0030193 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Symptoms of gastrointestinal illness- Date of Onset
Item
Symptoms of gastrointestinal illness- Date of Onset
date
C1457887 (UMLS CUI [1])
C0521362 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C0574845 (UMLS CUI [3])
C0521362 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C0574845 (UMLS CUI [3])
CL Item
Continuing (1)
Symptoms of gastrointestinal illness - Date of Resolution
Item
Symptoms of gastrointestinal illness - Date of Resolution
date
C1457887 (UMLS CUI [1])
C0521362 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C2985858 (UMLS CUI [3])
C0521362 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C2985858 (UMLS CUI [3])
Item Group
Other symptoms associated with pancreatitis
C0030305 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1457887 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
CL Item
Nausea (1)
CL Item
Vomiting (2)
CL Item
Fever (3)
CL Item
Other (4)
Specify other symptom
Item
Specify other symptom
text
C1457887 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Other symptoms - Date of Onset
Item
Other symptoms - Date of Onset
date
C1457887 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0574845 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0574845 (UMLS CUI [2])
Item
Other symptoms - Continuing
integer
C1457887 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [2])
CL Item
Continuing (1)
Other symptoms - Date of Resolution
Item
Other symptoms - Date of Resolution
date
C1457887 (UMLS CUI [1,1])
C2985858 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2985858 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Item Group
Pancreatitis - Lab results (Biochemistry)
C0030305 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
C0005477 (UMLS CUI-3)
C1254595 (UMLS CUI-2)
C0005477 (UMLS CUI-3)
Were biochemistry evaluations performed?
Item
Were biochemistry evaluations performed?
boolean
C0005477 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
Date sample taken (Biochemistry)
Item
Date sample taken (Biochemistry)
time
C0005477 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
Time sample taken (Biochemistry)
Item
Time sample taken (Biochemistry)
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item Group
Pancreatitis - Lab results (Biochemistry)
C0030305 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
C0005477 (UMLS CUI-3)
C1254595 (UMLS CUI-2)
C0005477 (UMLS CUI-3)
CL Item
Amylase (1)
CL Item
Lipase (2)
CL Item
Calcium (3)
CL Item
Triglyceride (4)
CL Item
ALT (5)
CL Item
AST (6)
CL Item
GGT (7)
CL Item
Alkaline phosphatase (8)
CL Item
Total bilirubin (9)
CL Item
Direct bilirubin (10)
CL Item
Creatinine (11)
CL Item
Other (12)
Was lab test performed?
Item
Was lab test performed?
boolean
C0022885 (UMLS CUI [1])
Lab test result
Item
Lab test result
text
C0587081 (UMLS CUI [1])
Lab unit
Item
Lab unit
text
C0022885 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Lab LLN
Item
Lab LLN
float
C0022885 (UMLS CUI [1])
C1518030 (UMLS CUI [2])
C1518030 (UMLS CUI [2])
Lab ULN
Item
Lab ULN
float
C0022885 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
C1519815 (UMLS CUI [2])
Specify other Lab test
Item
Specify other Lab test
text
C0022885 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Specify other Lab unit
Item
Specify other Lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item Group
Pancreatitis - Additional Lab results (Biochemistry)
C0030305 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
C0005477 (UMLS CUI-3)
C1524062 (UMLS CUI-4)
C1254595 (UMLS CUI-2)
C0005477 (UMLS CUI-3)
C1524062 (UMLS CUI-4)
Were additional Lab - Results Biochemistry evaluations performed?
Item
Were additional Lab - Results Biochemistry evaluations performed?
boolean
C1254595 (UMLS CUI [1])
C0005477 (UMLS CUI [2])
C1524062 (UMLS CUI [3])
C0005477 (UMLS CUI [2])
C1524062 (UMLS CUI [3])
Item Group
Pancreatitis - Diagnostic studies
C0030305 (UMLS CUI-1)
C0086143 (UMLS CUI-2)
C0086143 (UMLS CUI-2)
Was Abdominal Ultrasound performed?
Item
Was Abdominal Ultrasound performed?
boolean
C0041618 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
Date of Abdominal Ultrasound
Item
Date of Abdominal Ultrasound
date
C0000726 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0041618 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Item
Abdominal Ultrasound result
integer
C0000726 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2])
C0041618 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If Abdominal Ultrasound abnormal, evidence of cholelithiasis?
integer
C0041618 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0459424 (UMLS CUI [2])
C0008350 (UMLS CUI [3])
C0000726 (UMLS CUI [1,2])
C0459424 (UMLS CUI [2])
C0008350 (UMLS CUI [3])
Code List
If Abdominal Ultrasound abnormal, evidence of cholelithiasis?
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Was Abdominal CT Scan performed?
Item
Was Abdominal CT Scan performed?
boolean
C0412620 (UMLS CUI [1])
Date of Abdominal CT
Item
Date of Abdominal CT
date
C0412620 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
Item
Abdominal CT Result
integer
C0412620 (UMLS CUI [1])
C1274040 (UMLS CUI [2])
C1274040 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If Abdominal CT abnormal , what was the diagnostic finding?
integer
C0412620 (UMLS CUI [1])
C2826279 (UMLS CUI [2])
C2826279 (UMLS CUI [2])
Code List
If Abdominal CT abnormal , what was the diagnostic finding?
CL Item
Unknown (1)
CL Item
Cholelithiasis (2)
CL Item
Peripancreatic fluid collection (3)
CL Item
Pseudocysts (4)
CL Item
Edema of the small bowel mesentery (5)
CL Item
Pancreatic necrosis (6)
CL Item
Focal edema of the pancreas (7)
CL Item
Diffuse edema of the pancreas (8)
CL Item
Other (9)
Other diagnostic finding of abdomial ct
Item
Other diagnostic finding of abdomial ct
text
C0412620 (UMLS CUI [1])
C1335151 (UMLS CUI [2])
C1335151 (UMLS CUI [2])
Was an additional Abdominal CT Scan performed?
Item
Was an additional Abdominal CT Scan performed?
boolean
C0412620 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,2])
Was MRI performed?
Item
Was MRI performed?
boolean
C0024485 (UMLS CUI [1])
Date of MRI
Item
Date of MRI
date
C0024485 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If abnormal MRI, what was the diagnostic finding?
integer
C0436540 (UMLS CUI [1])
C0243095 (UMLS CUI [2])
C0243095 (UMLS CUI [2])
Code List
If abnormal MRI, what was the diagnostic finding?
CL Item
Unknown (1)
CL Item
Cholelithiasis (2)
CL Item
Peripancreatic fluid collection (3)
CL Item
Pseudocysts (4)
CL Item
Edema of the small bowel mesentery (5)
CL Item
Pancreatic necrosis (6)
CL Item
Focal edema of the pancreas (7)
CL Item
Diffuse edema of the pancreas (8)
CL Item
Other (9)
Other diagnostic finding of MRI
Item
Other diagnostic finding of MRI
text
C0024485 (UMLS CUI [1])
C1335151 (UMLS CUI [2])
C1335151 (UMLS CUI [2])
Was an additional MRI performed?
Item
Was an additional MRI performed?
boolean
C0024485 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,2])