Informationen:
Fehler:
ID
16855
Beschreibung
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
Stichworte
Versionen (1)
- 10.08.16 10.08.16 -
Hochgeladen am
10. August 2016
DOI
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Lizenz
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
Ähnliche Modelle
Liver Abnormality QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
text
C0545082 (UMLS CUI [1])
Code List
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Date of visit
Item
If Yes, please provide the Date of Visit.
date
Item Group
Unscheduled Event: Liver Abnormality
C3854240 (UMLS CUI-1)
C4021780 (UMLS CUI-2)
C4021780 (UMLS CUI-2)
Item
Form Not Done
text
C3854240 (UMLS CUI [1,1])
C4021780 (UMLS CUI [1,2])
C4021780 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Alcohol History
Item
Substance Use - Alcohol History
boolean
C0552479 (UMLS CUI [1])
Drug Abuse
Item
Substance Use - Drug Abuse
boolean
C0038586 (UMLS CUI [1])
Liver imaging
Item
Liver imaging
boolean
C2711860 (UMLS CUI [1])
Liver Abnormality Assessment: Serology
Item
Serology - Liver Abnormality Assessment
boolean
C4021780 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,2])
Liver Abnormality Assessment: Biochemistry
Item
Biochemistry - Liver Abnormality Assessment
boolean
C4021780 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
Liver Abnormality Assessment: Coagulation
Item
Coagulation - Liver Abnormality Assessment
boolean
C4021780 (UMLS CUI [1,1])
C0005778 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
Study Drug Interruption
Item
Study Drug Interruption
boolean
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,2])
Liver Abnormality Assessment: Comment
Item
Liver Abnormality Investigator Comments
boolean
C4021780 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item
Form Not Done
text
C0552479 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Item
State if Never Used Alcohol, Current Alcohol User, or Former Alcohol User
text
C0552479 (UMLS CUI [1])
CL Item
Never (Never)
CL Item
Current (Current)
CL Item
Former (Former)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Item
State if Never Abused Drugs, Current Drug User, or Former Drug User
text
C0038586 (UMLS CUI [1])
CL Item
Never (Never)
CL Item
Current (Current)
CL Item
Former (Former)
Item
Form Not Done
text
C2711860 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
CL Item
Ultrasound (Ultrasound)
CL Item
CT Scan (CT Scan)
Liver Imaging: Date
Item
Date Performed
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Liver Imaging: Time
Item
Time performed (00:00 - 23:59)
time
C2711860 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal - not clinically significant (Abnormal - not clinically significant)
CL Item
Abnormal - clinically significant (Abnormal - clinically significant)
Liver Imaging: Specification
Item
If abnormal, please specify diagnosis or describe abnormality:
text
C2711860 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Done (Done )
CL Item
Not Done (Not Done)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Hepatitis B Surface Antigen: Date
Item
Date of Sample Taken
date
C0019168 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0019168 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Item
LAB Test: Hepatitis B Surface Antibody
text
C0201478 (UMLS CUI [1])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Hepatitis B Surface Antibody: Date
Item
Date of Sample Taken
date
C0201478 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0201478 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Hepatitis B Core Antigen: Date
Item
Date of Sample Taken
date
C0201479 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0201479 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Done (Done )
CL Item
Not Done (Not Done)
Hepatitis B Core Antibody: Date
Item
Date of Sample Taken
date
C0201480 (UMLS CUI [1])
Item
Result
text
C0201480 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Hepatitis A Antibody IgM: Date
Item
Date of Sample Taken
date
C0373852 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0373852 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Negative (Negative )
CL Item
Positive (Positive)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Hepatitis A Antibody IgG: Date
Item
Date of Sample Taken
date
C0201474 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0201474 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Negative (Negative )
CL Item
Positive (Positive)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
HCV Antibody: Date
Item
Date Sample taken
date
C0201487 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Cytomegalovirus: Date
Item
Date of Sample Taken
date
C0010825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Epstein-Barr-Virus IgM: Date
Item
Date of Sample Taken
date
C1254702 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Item
LAB Test: Epstein-Barr-Virus Antibody IgG
text
C1254571 (UMLS CUI [1])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Epstein-Barr-Virus Antibody IgG: Date
Item
Date of Sample Taken
date
C1254571 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C1254571 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Item Group
Biochemistry - Liver Abnormality
C0005477 (UMLS CUI-1)
C4021780 (UMLS CUI-2)
C4021780 (UMLS CUI-2)
Item
Form Not Done
text
C0005477 (UMLS CUI [1,1])
C4021780 (UMLS CUI [1,2])
C4021780 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Biochemistry: Name of Laboratory
Item
Lab Name
text
C3258037 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
Biochemistry: Address of Laboratory
Item
Lab City, State/ Country
text
C3262820 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
Biochemistry - Liver Abnormality: Date
Item
Date of Sample Taken
date
C0011008 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase: Upper Limit
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1,1])
C0439085 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
ALT
Item
ALT/ SGPT
float
C0201836 (UMLS CUI [1])
ALT: Upper Limit
Item
ALT/ SGPT Upper Limit
float
C0201836 (UMLS CUI [1,1])
C0439085 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
AST
Item
AST/SGOT
float
C0201899 (UMLS CUI [1])
AST: Upper Limit
Item
AST/SGOT Upper Limit
float
C0201899 (UMLS CUI [1,1])
C0439085 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Item
Total Bilirubin: Unit
text
C0201913 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
mg/dL (mg/dL)
CL Item
umol/L (umol/L)
Total Bilirubin: Upper Limit
Item
Total Bilirubin Upper Limit
float
C0201913 (UMLS CUI [1,1])
C0439085 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
Item
Total Bilirubin: Upper Limit Unit
text
C0201913 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,3])
CL Item
mg/dL (mg/dL)
CL Item
umol/L (umol/L)
Item Group
Coagulation - Liver Abnormality
C0005778 (UMLS CUI-1)
C4021780 (UMLS CUI-2)
C4021780 (UMLS CUI-2)
Item
Form Not Done
text
C0005778 (UMLS CUI [1,1])
C4021780 (UMLS CUI [1,2])
C4021780 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Coagulation: Name of Laboratory
Item
Lab Name
text
C3258037 (UMLS CUI [1,1])
C0005778 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
Coagulation: Address of Laboratory
Item
Lab City, State/ Country
text
C3262820 (UMLS CUI [1,1])
C0005778 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
Coagulation - Liver Abnormality: Date
Item
Date of Sample Taken
date
C0005778 (UMLS CUI [1,1])
C4021780 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C4021780 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
INR
Item
Prothrombin Time Intl. Normalized Ratio
float
C0525032 (UMLS CUI [1])
INR: Upper Limit
Item
Prothrombin Time Intl. Normalized Ratio Upper Limit
float
C0525032 (UMLS CUI [1,1])
C0439085 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,2])
Item Group
Study Drug Interruption
C0304229 (UMLS CUI-1)
C1512900 (UMLS CUI-2)
C1512900 (UMLS CUI-2)
Item
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG" and if this form was added in error.)
text
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,2])
Code List
Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG" and if this form was added in error.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Study Drug Interruption: Liver Abnormality
Item
Was study drug interrupted (and re-started) due to Liver Abnormalities?
boolean
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C4021780 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,2])
C4021780 (UMLS CUI [1,3])
Date of Missed Dose
Item
If Yes, please add a log line to record each date study medication dosing was missed.
date
C1709043 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Form Not Done (Comments must be accompanied by source documentation)
text
C0947611 (UMLS CUI [1])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Date of Comment
Item
Date of Comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Liver Abnormality Investigator Comments
Item
Liver Abnormality Investigator Comments
text
C4021780 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])