ID
35640
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-03-13 2019-03-13 -
Rättsinnehavare
GSK group of companies
Uppladdad den
13 mars 2019
DOI
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Licens
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
Beskrivning
Liver Event
Beskrivning
If no liver event, tick No and enter date of study conclusion/withdrawal above
Datatyp
boolean
Beskrivning
Liver Chemistry Results - Exceeding
Datatyp
text
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
age
Datatyp
boolean
Beskrivning
pregnancy
Datatyp
text
Beskrivning
e.g. iver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other
Datatyp
boolean
Beskrivning
Results of diagnostic imaging
Datatyp
boolean
Beskrivning
biopsy
Datatyp
boolean
Beskrivning
concomitant substances
Datatyp
boolean
Beskrivning
dietary change
Datatyp
boolean
Beskrivning
Investigational Product
Beskrivning
Pharmacokinetics - Blood
Beskrivning
Medical Conditions
Beskrivning
Acute Viral Hepatitis A
Datatyp
integer
Alias
- UMLS CUI [1]
- C0276434
Beskrivning
Chronic Hepatitis B
Datatyp
integer
Alias
- UMLS CUI [1]
- C0524909
Beskrivning
Cytomegalovirus Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0276252
Beskrivning
Epstein Barr Virus Infectious Mononucleosis
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Beskrivning
Herpes Simplex Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C1963747
Beskrivning
Alcoholic Liver Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023896
Beskrivning
Non-alcoholic Steatohepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C3241937
Beskrivning
Fatty Liver
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015695
Beskrivning
Hepatic Orrhosis
Datatyp
integer
Beskrivning
Hematochromatosis
Datatyp
integer
Beskrivning
Autoimmune Hepatitis
Datatyp
integer
Beskrivning
Gallbladder disease or biliary disease
Datatyp
integer
Beskrivning
Drug Related Liver Disease Conditions
Beskrivning
Other Liver Disease Conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beskrivning
Sequence Number
Datatyp
text
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Specific Condition
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Status of liver disease condition
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0449438
Beskrivning
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beskrivning
Drug allergies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Beskrivning
Rheumatoid Arthritis
Datatyp
text
Alias
- UMLS CUI [1]
- C0003873
Beskrivning
Psoriasis
Datatyp
text
Alias
- UMLS CUI [1]
- C0033860
Beskrivning
Thyroid Disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0040128
Beskrivning
Inflammatory Bowel Disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Lupus
Datatyp
text
Alias
- UMLS CUI [1]
- C0409974
Beskrivning
Sjogrens Syndrome
Datatyp
text
Alias
- UMLS CUI [1]
- C1527336
Beskrivning
Vitiligo
Datatyp
text
Alias
- UMLS CUI [1]
- C0042900
Beskrivning
Alcohol Intake
Beskrivning
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Beskrivning
Date of hepatic or liver imaging tes
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0011008
Beskrivning
Method used for this imaging test
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
Beskrivning
Other method used for imaging test
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Are images technically adequate?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0806487
Beskrivning
Other image quality
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0806487
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Indicate the liver size
Datatyp
integer
Alias
- UMLS CUI [1]
- C0426688
Beskrivning
Other liver size
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0426688
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Indicate the liver texture.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0679033
- UMLS CUI [1,2]
- C0023884
Beskrivning
Other liver texture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0679033
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Beskrivning
Grade the diffuse and/ or geographic fatty infiltrate of the liver
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Beskrivning
Other fatty infiltrate of the liver
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Ascites present
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003962
Beskrivning
Other ascites
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0003962
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Focal hepatic lesions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
Beskrivning
Other focal hepatic lesions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Gallstones or gallbladder lesions?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3842395
- UMLS CUI [1,2]
- C0221198
Beskrivning
Other gallstones or gallbladder lesions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3842395
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Biliary ductal lesions?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Beskrivning
Other biliary ductal lesions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Beskrivning
Portal/ Hepatic vein abnormalities?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
Beskrivning
Other portal/ hepatic vein abnormalities
Datatyp
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
Beskrivning
Liver Biopsy
Alias
- UMLS CUI-1
- C0193388
Beskrivning
Date of Liver Biopsy
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0011008
Beskrivning
Approximate size of liver biopsy
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C1299482
- UMLS CUI [1,2]
- C0193388
Beskrivning
Final Diagnosis Liver Biopsy
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Beskrivning
Final Diagnosis Liver Biopsy
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
- UMLS CUI [1,3]
- C0205161
Beskrivning
Final Diagnosis Liver Biopsy
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0193388
Beskrivning
Liver Architecture
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Beskrivning
Liver Architecture
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205161
Beskrivning
Liver Architecture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Beskrivning
Description of Liver Cells or Hepatocytes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Beskrivning
Description of Liver Cells or Hepatocytes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0678257
Beskrivning
Description of Liver Cells or Hepatocytes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Beskrivning
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Beskrivning
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Beskrivning
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0042219
- UMLS CUI [2]
- C1512693
Beskrivning
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Beskrivning
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Beskrivning
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C1849376
Beskrivning
Liver or Lobular Infiltrates
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1400896
Beskrivning
Liver or Lobular Infiltrates
Datatyp
integer
Alias
- UMLS CUI [1]
- C1400896
Beskrivning
Liver or Lobular Infiltrates
Datatyp
text
Alias
- UMLS CUI [1]
- C1400896
Beskrivning
Portal Tract Inflammation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3854488
Beskrivning
Portal Tract Inflammation
Datatyp
integer
Alias
- UMLS CUI [1]
- C3854488
Beskrivning
Portal Tract Inflammation
Datatyp
text
Alias
- UMLS CUI [1]
- C3854488
Beskrivning
Bile Ducts
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005400
Beskrivning
Bile Ducts
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Beskrivning
Bile Ducts
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0205161
Beskrivning
Portal Veins
Datatyp
integer
Alias
- UMLS CUI [1]
- C0032718
Beskrivning
Portal Veins
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Beskrivning
Portal Veins
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0205161
Beskrivning
Liver Infections
Datatyp
integer
Alias
- UMLS CUI [1]
- C1112211
Beskrivning
Liver Infections
Datatyp
integer
Alias
- UMLS CUI [1]
- C1112211
Beskrivning
Liver Infections
Datatyp
text
Alias
- UMLS CUI [1]
- C1112211
Beskrivning
Parasites or ova
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Beskrivning
Parasites or ova
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Beskrivning
Parasites or ova
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0030498
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2]
- C0555117
Beskrivning
Histologic Staining or Additional Studies Obtained
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
Beskrivning
Histologic Staining or Additional Studies Obtained
Datatyp
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])