ID
35640
Description
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
Keywords
Versions (1)
- 3/13/19 3/13/19 -
Copyright Holder
GSK group of companies
Uploaded on
March 13, 2019
DOI
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License
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
Description
Liver Event
Description
If no liver event, tick No and enter date of study conclusion/withdrawal above
Data type
boolean
Description
Liver Chemistry Results - Exceeding
Data type
text
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
age
Data type
boolean
Description
pregnancy
Data type
text
Description
e.g. iver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other
Data type
boolean
Description
Results of diagnostic imaging
Data type
boolean
Description
biopsy
Data type
boolean
Description
concomitant substances
Data type
boolean
Description
dietary change
Data type
boolean
Description
Investigational Product
Description
Pharmacokinetics - Blood
Description
Medical Conditions
Description
Acute Viral Hepatitis A
Data type
integer
Alias
- UMLS CUI [1]
- C0276434
Description
Chronic Hepatitis B
Data type
integer
Alias
- UMLS CUI [1]
- C0524909
Description
Cytomegalovirus Hepatitis
Data type
integer
Alias
- UMLS CUI [1]
- C0276252
Description
Epstein Barr Virus Infectious Mononucleosis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Description
Herpes Simplex Hepatitis
Data type
integer
Alias
- UMLS CUI [1]
- C1963747
Description
Alcoholic Liver Disease
Data type
integer
Alias
- UMLS CUI [1]
- C0023896
Description
Non-alcoholic Steatohepatitis
Data type
text
Alias
- UMLS CUI [1]
- C3241937
Description
Fatty Liver
Data type
integer
Alias
- UMLS CUI [1]
- C0015695
Description
Hepatic Orrhosis
Data type
integer
Description
Hematochromatosis
Data type
integer
Description
Autoimmune Hepatitis
Data type
integer
Description
Gallbladder disease or biliary disease
Data type
integer
Description
Drug Related Liver Disease Conditions
Description
Other Liver Disease Conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Description
Sequence Number
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Specific Condition
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Status of liver disease condition
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0449438
Description
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Description
Drug allergies
Data type
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Description
Rheumatoid Arthritis
Data type
text
Alias
- UMLS CUI [1]
- C0003873
Description
Psoriasis
Data type
text
Alias
- UMLS CUI [1]
- C0033860
Description
Thyroid Disease
Data type
text
Alias
- UMLS CUI [1]
- C0040128
Description
Inflammatory Bowel Disease
Data type
text
Alias
- UMLS CUI [1]
- C0021390
Description
Lupus
Data type
text
Alias
- UMLS CUI [1]
- C0409974
Description
Sjogrens Syndrome
Data type
text
Alias
- UMLS CUI [1]
- C1527336
Description
Vitiligo
Data type
text
Alias
- UMLS CUI [1]
- C0042900
Description
Alcohol Intake
Description
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Description
Date of hepatic or liver imaging tes
Data type
date
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0011008
Description
Method used for this imaging test
Data type
integer
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
Description
Other method used for imaging test
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Are images technically adequate?
Data type
integer
Alias
- UMLS CUI [1]
- C0806487
Description
Other image quality
Data type
text
Alias
- UMLS CUI [1,1]
- C0806487
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Indicate the liver size
Data type
integer
Alias
- UMLS CUI [1]
- C0426688
Description
Other liver size
Data type
text
Alias
- UMLS CUI [1,1]
- C0426688
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Indicate the liver texture.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0679033
- UMLS CUI [1,2]
- C0023884
Description
Other liver texture
Data type
text
Alias
- UMLS CUI [1,1]
- C0679033
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Description
Grade the diffuse and/ or geographic fatty infiltrate of the liver
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Description
Other fatty infiltrate of the liver
Data type
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Ascites present
Data type
integer
Alias
- UMLS CUI [1]
- C0003962
Description
Other ascites
Data type
text
Alias
- UMLS CUI [1,1]
- C0003962
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Focal hepatic lesions
Data type
integer
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
Description
Other focal hepatic lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Gallstones or gallbladder lesions?
Data type
integer
Alias
- UMLS CUI [1,1]
- C3842395
- UMLS CUI [1,2]
- C0221198
Description
Other gallstones or gallbladder lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C3842395
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Biliary ductal lesions?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Description
Other biliary ductal lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Description
Portal/ Hepatic vein abnormalities?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
Description
Other portal/ hepatic vein abnormalities
Data type
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
Description
Liver Biopsy
Alias
- UMLS CUI-1
- C0193388
Description
Date of Liver Biopsy
Data type
date
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0011008
Description
Approximate size of liver biopsy
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C1299482
- UMLS CUI [1,2]
- C0193388
Description
Final Diagnosis Liver Biopsy
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Description
Final Diagnosis Liver Biopsy
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
- UMLS CUI [1,3]
- C0205161
Description
Final Diagnosis Liver Biopsy
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Description
Liver Architecture
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Description
Liver Architecture
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205161
Description
Liver Architecture
Data type
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Description
Description of Liver Cells or Hepatocytes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Description
Description of Liver Cells or Hepatocytes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0678257
Description
Description of Liver Cells or Hepatocytes
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Description
Liver Cell or Hepatocyte Inclusions or Vacuoles
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Description
Hepatocyte or Liver Cell Nuclear Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Description
Liver or Lobular Infiltrates
Data type
boolean
Alias
- UMLS CUI [1]
- C1400896
Description
Liver or Lobular Infiltrates
Data type
integer
Alias
- UMLS CUI [1]
- C1400896
Description
Liver or Lobular Infiltrates
Data type
text
Alias
- UMLS CUI [1]
- C1400896
Description
Portal Tract Inflammation
Data type
boolean
Alias
- UMLS CUI [1]
- C3854488
Description
Portal Tract Inflammation
Data type
integer
Alias
- UMLS CUI [1]
- C3854488
Description
Portal Tract Inflammation
Data type
text
Alias
- UMLS CUI [1]
- C3854488
Description
Bile Ducts
Data type
integer
Alias
- UMLS CUI [1]
- C0005400
Description
Bile Ducts
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Description
Bile Ducts
Data type
text
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Description
Portal Veins
Data type
integer
Alias
- UMLS CUI [1]
- C0032718
Description
Portal Veins
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Description
Portal Veins
Data type
text
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Description
Liver Infections
Data type
integer
Alias
- UMLS CUI [1]
- C1112211
Description
Liver Infections
Data type
integer
Alias
- UMLS CUI [1]
- C1112211
Description
Liver Infections
Data type
text
Alias
- UMLS CUI [1]
- C1112211
Description
Parasites or ova
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Description
Parasites or ova
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Description
Parasites or ova
Data type
text
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Description
Histologic Staining or Additional Studies Obtained
Data type
integer
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Description
Histologic Staining or Additional Studies Obtained
Data type
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
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- StudyEvent: ODM
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C0193388 (UMLS CUI [1,2])
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C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
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C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])