ID
16855
Description
QUTENZA™ versus Pregabalin in Subjects with Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0004 Trial Registry Identification Number(#'s) NCT01713426 EudraCT Number: 2011-005872-41
Keywords
Versions (1)
- 8/10/16 8/10/16 -
Uploaded on
August 10, 2016
DOI
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License
Creative Commons BY-NC-ND 3.0
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Liver Abnormality QTZ-EC-0004 ELEVATE NCT01713426
Liver Abnormality QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Description
Unscheduled Event: Liver Abnormality
Alias
- UMLS CUI-1
- C3854240
- UMLS CUI-2
- C4021780
Description
Unscheduled Event: Liver Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C4021780
Description
Alcohol History
Data type
boolean
Alias
- UMLS CUI [1]
- C0552479
Description
Drug Abuse
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
Liver imaging
Data type
boolean
Alias
- UMLS CUI [1]
- C2711860
Description
Liver Abnormality Assessment: Serology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4021780
- UMLS CUI [1,2]
- C0036743
Description
Liver Abnormality Assessment: Biochemistry
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4021780
- UMLS CUI [1,2]
- C0005477
Description
Liver Abnormality Assessment: Coagulation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4021780
- UMLS CUI [1,2]
- C0005778
Description
Study Drug Interruption
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1512900
Description
Liver Abnormality Assessment: Comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4021780
- UMLS CUI [1,2]
- C0947611
Description
Substance Use - Alcohol History
Alias
- UMLS CUI-1
- C0552479
Description
Substance Use - Drug Abuse
Alias
- UMLS CUI-1
- C0038586
Description
Liver Imaging
Alias
- UMLS CUI-1
- C2711860
Description
Liver Imaging: Performed
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0884358
Description
Liver Imaging: Method
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
Description
Liver Imaging: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0011008
Description
Liver Imaging: Time
Data type
time
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0040223
Description
Liver Imaging: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1274040
Description
Liver Imaging: Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C2348235
Description
Serology - Liver Abnormality Assessment
Alias
- UMLS CUI-1
- C0036743
Description
Serology: Performed
Data type
text
Alias
- UMLS CUI [1]
- C0036743
Description
Hepatitis B Surface Antigen
Data type
text
Alias
- UMLS CUI [1]
- C0019168
Description
Hepatitis B Surface Antigen: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0011008
Description
Hepatitis B Surface Antigen: Result
Data type
text
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C1274040
Description
Hepatitis B Surface Antibody
Data type
text
Alias
- UMLS CUI [1]
- C0201478
Description
Hepatitis B Surface Antibody: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0201478
- UMLS CUI [1,2]
- C0011008
Description
Hepatitis B Surface Antibody: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0201478
- UMLS CUI [1,2]
- C1274040
Description
Hepatitis B Core Antigen
Data type
text
Alias
- UMLS CUI [1]
- C0201479
Description
Hepatitis B Core Antigen: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0201479
- UMLS CUI [1,2]
- C0011008
Description
Hepatitis B Core Antigen: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0201479
- UMLS CUI [1,2]
- C1274040
Description
Hepatitis B Core Antibody
Data type
text
Alias
- UMLS CUI [1]
- C0201480
Description
Hepatitis B Core Antibody: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1]
- C0201480
Description
Hepatitis B Core Antibody: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0201480
- UMLS CUI [1,2]
- C1274040
Description
Hepatitis A Antibody IgM
Data type
text
Alias
- UMLS CUI [1]
- C0373852
Description
Hepatitis A Antibody IgM: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C0011008
Description
Hepatitis A Antibody IgM: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C1274040
Description
Hepatitis A Antibody IgG
Data type
text
Alias
- UMLS CUI [1]
- C0201474
Description
Hepatitis A Antibody IgG: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0201474
- UMLS CUI [1,2]
- C0011008
Description
Hepatitis A Antibody IgG: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0201474
- UMLS CUI [1,2]
- C1274040
Description
HCV Antibody
Data type
text
Alias
- UMLS CUI [1]
- C0201487
Description
HCV Antibody: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0201487
- UMLS CUI [1,2]
- C0011008
Description
HCV Antibody: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0201487
- UMLS CUI [1,2]
- C1274040
Description
Cytomegalovirus
Data type
text
Alias
- UMLS CUI [1]
- C0010825
Description
Cytomegalovirus: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0010825
- UMLS CUI [1,2]
- C0011008
Description
Cytomegalovirus: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0010825
- UMLS CUI [1,2]
- C1274040
Description
Epstein-Barr-Virus IgM
Data type
text
Alias
- UMLS CUI [1]
- C1254702
Description
Epstein-Barr-Virus IgM: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C1254702
- UMLS CUI [1,2]
- C0011008
Description
Epstein-Barr-Virus IgM: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C1254702
- UMLS CUI [1,2]
- C1274040
Description
Epstein-Barr-Virus Antibody IgG
Data type
text
Alias
- UMLS CUI [1]
- C1254571
Description
Epstein-Barr-Virus Antibody IgG: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C1254571
- UMLS CUI [1,2]
- C0011008
Description
Epstein-Barr-Virus Antibody IgG: Result
Data type
text
Alias
- UMLS CUI [1,1]
- C1254571
- UMLS CUI [1,2]
- C1274040
Description
Biochemistry - Liver Abnormality
Alias
- UMLS CUI-1
- C0005477
- UMLS CUI-2
- C4021780
Description
Biochemistry - Liver Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0005477
- UMLS CUI [1,2]
- C4021780
Description
Biochemistry: Name of Laboratory
Data type
text
Alias
- UMLS CUI [1,1]
- C3258037
- UMLS CUI [1,2]
- C0005477
Description
Biochemistry: Address of Laboratory
Data type
text
Alias
- UMLS CUI [1,1]
- C3262820
- UMLS CUI [1,2]
- C0005477
Description
Biochemistry - Liver Abnormality: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1]
- C0011008
Description
Alkaline Phosphatase
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Alkaline Phosphatase: Upper Limit
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0439085
Description
ALT
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
ALT: Upper Limit
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0439085
Description
AST
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
AST: Upper Limit
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0439085
Description
Total Bilirubin
Data type
float
Alias
- UMLS CUI [1]
- C0201913
Description
Total Bilirubin: Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519795
Description
Total Bilirubin: Upper Limit
Data type
float
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0439085
Description
Total Bilirubin: Upper Limit Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519795
- UMLS CUI [1,3]
- C0439085
Description
Coagulation - Liver Abnormality
Alias
- UMLS CUI-1
- C0005778
- UMLS CUI-2
- C4021780
Description
Coagulation - Liver Abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0005778
- UMLS CUI [1,2]
- C4021780
Description
Coagulation: Name of Laboratory
Data type
text
Alias
- UMLS CUI [1,1]
- C3258037
- UMLS CUI [1,2]
- C0005778
Description
Coagulation: Address of Laboratory
Data type
text
Alias
- UMLS CUI [1,1]
- C3262820
- UMLS CUI [1,2]
- C0005778
Description
Coagulation - Liver Abnormality: Date
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0005778
- UMLS CUI [1,2]
- C4021780
- UMLS CUI [1,3]
- C0011008
Description
INR
Data type
float
Alias
- UMLS CUI [1]
- C0525032
Description
INR: Upper Limit
Data type
float
Alias
- UMLS CUI [1,1]
- C0525032
- UMLS CUI [1,2]
- C0439085
Description
Study Drug Interruption
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1512900
Description
Study Drug Interruption
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1512900
Description
Study Drug Interruption: Liver Abnormality
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1512900
- UMLS CUI [1,3]
- C4021780
Description
Date of Missed Dose
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C1709043
- UMLS CUI [1,2]
- C0011008
Description
Comments
Alias
- UMLS CUI-1
- C0947611
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Date of Comment
Data type
date
Measurement units
- dd/MMM/yyyy
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Description
Liver Abnormality Investigator Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C4021780
- UMLS CUI [1,2]
- C0947611
Similar models
Liver Abnormality QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
C4021780 (UMLS CUI-2)
C4021780 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C4021780 (UMLS CUI-2)
C4021780 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,3])
C4021780 (UMLS CUI-2)
C4021780 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
C4021780 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439085 (UMLS CUI [1,2])
C1512900 (UMLS CUI-2)
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,2])
C4021780 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])