ID

30165

Descripción

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Medical Conditions at onset of Liver Event

Link

https://clinicaltrials.gov/ct2/show/NCT01036061

Palabras clave

Versiones (1)
  1. 16/5/18 16/5/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de mayo de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

Inglés

Medical Conditions at onset of Liver Event

1 formularios  
Liver Disease Medical Conditions
Descripción

Liver Disease Medical Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0262926
UMLS CUI-3
C1556667
Acute Viral Hepatitis A
Descripción

Acute Viral Hepatitis A

Tipo de datos

integer

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Descripción

Chronic Hepatitis B

Tipo de datos

integer

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Descripción

Chronic Hepatitis C

Tipo de datos

integer

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Descripción

Cytomegalovirus Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0276252
Epstein Barr Virus Infectious Mononucleosis
Descripción

Epstein Barr Virus Infectious Mononucleosis

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
Herpes Simplex Hepatitis
Descripción

Herpes Simplex Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Descripción

Alcoholic Liver Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0023896
Non-alcoholic Steatohepatltls
Descripción

Non-alcoholic Steatohepatltls

Tipo de datos

integer

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Descripción

Fatty Liver

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Descripción

Hepatic Cirrhosis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Descripción

Hemochromatosis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Descripción

Autoimmune Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Descripción

Gallbladder disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0016977
UMLS CUI [2]
C3275124
Drug related liver disease
Descripción

(All drugs including lnvestigational Product)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other liver disease conditions
Descripción

Other liver disease conditions

Alias
UMLS CUI-1
C0023895
Other liver disease
Descripción

Other liver disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0023895
Sequence Number
Descripción

Sequence Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348184
Specific Condition
Descripción

Specific Condition

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Modified Term
Descripción

Modified Term

Tipo de datos

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Descripción

MedDRA Synonym

Tipo de datos

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Descripción

MedDRA lower level term code

Tipo de datos

text

Alias
UMLS CUI [1]
C2347090
Failed coding
Descripción

Failed coding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Status
Descripción

Status

Tipo de datos

integer

Alias
UMLS CUI [1]
C0449438
Other medical conditions
Descripción

Other medical conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
Drug allergies
Descripción

Drug allergies

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
Rheumatoid Arthritis
Descripción

Rheumatoid Arthritis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Descripción

Psoriasis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Descripción

Thyroid Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Descripción

Inflammatory Bowel Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Descripción

Lupus

Tipo de datos

integer

Alias
UMLS CUI [1]
C0409974
Sjogrens Syndrome
Descripción

Sjogrens Syndrome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Descripción

Vitiligo

Tipo de datos

integer

Alias
UMLS CUI [1]
C0042900
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Similar models

Medical Conditions at onset of Liver Event

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Liver Disease Medical Conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
Item
Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Acute Viral Hepatitis A
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Chronic Hepatitis B
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Chronic Hepatitis C
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Cytomegalovirus Hepatitis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Herpes Simplex Hepatitis
integer
C1963747 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Herpes Simplex Hepatitis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Alcoholic Liver Disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Non-alcoholic Steatohepatltls
integer
C3241937 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Non-alcoholic Steatohepatltls
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Fatty Liver
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Hepatic Cirrhosis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Hemochromatosis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Autoimmune Hepatitis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
Acute Viral Hepatitis A
Code List
Gallbladder disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
Drug related liver disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other liver disease conditions
C0023895 (UMLS CUI-1)
Item
Other liver disease
integer
C0023895 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Other liver disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2347090 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Current (1)
(Comment:en)
CL Item
Past (2)
(Comment:en)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Drug allergies
integer
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
Drug allergies
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Rheumatoid Arthritis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Psoriasis
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Thyroid Disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Inflammatory Bowel Disease
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Lupus
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Sjogrens Syndrome
integer
C1527336 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Sjogrens Syndrome
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Vitiligo
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
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