ID
35640
Beschrijving
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis
Trefwoorden
Versies (1)
- 13-03-19 13-03-19 -
Houder van rechten
GSK group of companies
Geüploaded op
13 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611
Liver Event Form
- StudyEvent: ODM
Beschrijving
Liver Event
Beschrijving
If no liver event, tick No and enter date of study conclusion/withdrawal above
Datatype
boolean
Beschrijving
Liver Chemistry Results - Exceeding
Datatype
text
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria? This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria? This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beschrijving
age
Datatype
boolean
Beschrijving
pregnancy
Datatype
text
Beschrijving
e.g. iver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other
Datatype
boolean
Beschrijving
Results of diagnostic imaging
Datatype
boolean
Beschrijving
biopsy
Datatype
boolean
Beschrijving
concomitant substances
Datatype
boolean
Beschrijving
dietary change
Datatype
boolean
Beschrijving
Investigational Product
Beschrijving
Pharmacokinetics - Blood
Beschrijving
Medical Conditions
Beschrijving
Acute Viral Hepatitis A
Datatype
integer
Alias
- UMLS CUI [1]
- C0276434
Beschrijving
Chronic Hepatitis B
Datatype
integer
Alias
- UMLS CUI [1]
- C0524909
Beschrijving
Cytomegalovirus Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C0276252
Beschrijving
Epstein Barr Virus Infectious Mononucleosis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Beschrijving
Herpes Simplex Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C1963747
Beschrijving
Alcoholic Liver Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0023896
Beschrijving
Non-alcoholic Steatohepatitis
Datatype
text
Alias
- UMLS CUI [1]
- C3241937
Beschrijving
Fatty Liver
Datatype
integer
Alias
- UMLS CUI [1]
- C0015695
Beschrijving
Hepatic Orrhosis
Datatype
integer
Beschrijving
Hematochromatosis
Datatype
integer
Beschrijving
Autoimmune Hepatitis
Datatype
integer
Beschrijving
Gallbladder disease or biliary disease
Datatype
integer
Beschrijving
Drug Related Liver Disease Conditions
Beschrijving
Other Liver Disease Conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschrijving
Sequence Number
Datatype
text
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Specific Condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Status of liver disease condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0449438
Beschrijving
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschrijving
Drug allergies
Datatype
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Beschrijving
Rheumatoid Arthritis
Datatype
text
Alias
- UMLS CUI [1]
- C0003873
Beschrijving
Psoriasis
Datatype
text
Alias
- UMLS CUI [1]
- C0033860
Beschrijving
Thyroid Disease
Datatype
text
Alias
- UMLS CUI [1]
- C0040128
Beschrijving
Inflammatory Bowel Disease
Datatype
text
Alias
- UMLS CUI [1]
- C0021390
Beschrijving
Lupus
Datatype
text
Alias
- UMLS CUI [1]
- C0409974
Beschrijving
Sjogrens Syndrome
Datatype
text
Alias
- UMLS CUI [1]
- C1527336
Beschrijving
Vitiligo
Datatype
text
Alias
- UMLS CUI [1]
- C0042900
Beschrijving
Alcohol Intake
Beschrijving
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Beschrijving
Date of hepatic or liver imaging tes
Datatype
date
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0011008
Beschrijving
Method used for this imaging test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
Beschrijving
Other method used for imaging test
Datatype
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Are images technically adequate?
Datatype
integer
Alias
- UMLS CUI [1]
- C0806487
Beschrijving
Other image quality
Datatype
text
Alias
- UMLS CUI [1,1]
- C0806487
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Indicate the liver size
Datatype
integer
Alias
- UMLS CUI [1]
- C0426688
Beschrijving
Other liver size
Datatype
text
Alias
- UMLS CUI [1,1]
- C0426688
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Indicate the liver texture.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0679033
- UMLS CUI [1,2]
- C0023884
Beschrijving
Other liver texture
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679033
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Beschrijving
Grade the diffuse and/ or geographic fatty infiltrate of the liver
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Beschrijving
Other fatty infiltrate of the liver
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Ascites present
Datatype
integer
Alias
- UMLS CUI [1]
- C0003962
Beschrijving
Other ascites
Datatype
text
Alias
- UMLS CUI [1,1]
- C0003962
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Focal hepatic lesions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
Beschrijving
Other focal hepatic lesions
Datatype
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Gallstones or gallbladder lesions?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3842395
- UMLS CUI [1,2]
- C0221198
Beschrijving
Other gallstones or gallbladder lesions
Datatype
text
Alias
- UMLS CUI [1,1]
- C3842395
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Biliary ductal lesions?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Beschrijving
Other biliary ductal lesions
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Beschrijving
Portal/ Hepatic vein abnormalities?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
Beschrijving
Other portal/ hepatic vein abnormalities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0205394
- UMLS CUI [2,4]
- C2348235
Beschrijving
Liver Biopsy
Alias
- UMLS CUI-1
- C0193388
Beschrijving
Date of Liver Biopsy
Datatype
date
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0011008
Beschrijving
Approximate size of liver biopsy
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C1299482
- UMLS CUI [1,2]
- C0193388
Beschrijving
Final Diagnosis Liver Biopsy
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Beschrijving
Final Diagnosis Liver Biopsy
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
- UMLS CUI [1,3]
- C0205161
Beschrijving
Final Diagnosis Liver Biopsy
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Beschrijving
Liver Architecture
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Beschrijving
Liver Architecture
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205161
Beschrijving
Liver Architecture
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Beschrijving
Description of Liver Cells or Hepatocytes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Beschrijving
Description of Liver Cells or Hepatocytes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0678257
Beschrijving
Description of Liver Cells or Hepatocytes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Beschrijving
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Beschrijving
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Beschrijving
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatype
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Beschrijving
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Beschrijving
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Beschrijving
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Beschrijving
Liver or Lobular Infiltrates
Datatype
boolean
Alias
- UMLS CUI [1]
- C1400896
Beschrijving
Liver or Lobular Infiltrates
Datatype
integer
Alias
- UMLS CUI [1]
- C1400896
Beschrijving
Liver or Lobular Infiltrates
Datatype
text
Alias
- UMLS CUI [1]
- C1400896
Beschrijving
Portal Tract Inflammation
Datatype
boolean
Alias
- UMLS CUI [1]
- C3854488
Beschrijving
Portal Tract Inflammation
Datatype
integer
Alias
- UMLS CUI [1]
- C3854488
Beschrijving
Portal Tract Inflammation
Datatype
text
Alias
- UMLS CUI [1]
- C3854488
Beschrijving
Bile Ducts
Datatype
integer
Alias
- UMLS CUI [1]
- C0005400
Beschrijving
Bile Ducts
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Beschrijving
Bile Ducts
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Beschrijving
Portal Veins
Datatype
integer
Alias
- UMLS CUI [1]
- C0032718
Beschrijving
Portal Veins
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Beschrijving
Portal Veins
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Beschrijving
Liver Infections
Datatype
integer
Alias
- UMLS CUI [1]
- C1112211
Beschrijving
Liver Infections
Datatype
integer
Alias
- UMLS CUI [1]
- C1112211
Beschrijving
Liver Infections
Datatype
text
Alias
- UMLS CUI [1]
- C1112211
Beschrijving
Parasites or ova
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Beschrijving
Parasites or ova
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Beschrijving
Parasites or ova
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Beschrijving
Histologic Staining or Additional Studies Obtained
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Beschrijving
Histologic Staining or Additional Studies Obtained
Datatype
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Similar models
Liver Event Form
- StudyEvent: ODM
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0014644 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C0011008 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0935919 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])