ID

16816

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)
  1. 8/8/16 8/8/16 -
Uploaded on

August 8, 2016

DOI

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License

Creative Commons BY-NC-ND 3.0
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Unscheduled Event QTZ-EC-0004 ELEVATE NCT01713426

English

Unscheduled Event QTZ-EC-0004 ELEVATE NCT01713426

1 forms  
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Was this visit performed? (If No, then all other forms with the Form Not Done field in this visit will be marked not done.)
Description

Visit

Data type

boolean

Alias
UMLS CUI [1]
C0545082
If Yes, please provide the Date of Visit.
Description

Date of visit

Data type

date

Measurement units
  • dd/MMM/yyyy
dd/MMM/yyyy
Unscheduled Event Checklist
Description

Unscheduled Event Checklist

Alias
UMLS CUI-1
C3854240
UMLS CUI-2
C1707357
Please select the procedures performed at this visit
Description

Procedures at visit

Data type

text

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0545082
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Form Not Done
Description

Physical Examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Assessment Date
Description

Assessment Date

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C2985720
dd/MMM/yyyy
Record any abnormal findings/ conditions identified during the exam on the appropriate form. For Screening/ Baseline visits, report abnormal findings/ conditions on the appropriate form. For Screening/Baseline visits, report abnormal findings/ conditions on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal findings/conditions that have worsened from Screening/Baseline and are clinically significant on the Adverse Events form.
Description

Physical Examination: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0947611
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Form Not Done
Description

Vital signs

Data type

text

Alias
UMLS CUI [1]
C0518766
Assessment Date
Description

Assessment Date

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1]
C2985720
dd/MMM/yyyy
Position
Description

Position

Data type

text

Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pulse

Data type

float

Measurement units
  • Beats/Min
Alias
UMLS CUI [1]
C0232117
Beats/Min
Record any abnormal results on the appropriate form. For Screening/Baseline visits, report abnormal results on the appropriate form (Medical History or Adverse Event). For Post-Baseline visits, record abnormal results that have worsened from Screening/ Baseline and are clinicallly significant on the Adverse Event form.
Description

Vital Signs: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0947611
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
Description

Pregnancy Test

Data type

text

Alias
UMLS CUI [1]
C0032976
If Pregnancy Test was not done, please provide reason:
Description

Pregnancy Test: Reason

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0392360
If `Other`, specify:
Description

Pregnancy Test: Reason Specification

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348235
Date of Sample Taken
Description

Pregnancy Test: Date

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
dd/MMM/yyyy
Result of Pregnancy Test
Description

Pregnancy Test: Result

Data type

text

Alias
UMLS CUI [1]
C0427777
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Form Not Done
Description

Hematology

Data type

text

Alias
UMLS CUI [1]
C0474523
Were samples taken?
Description

Hematology: samples taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1277698
Date of Sample Taken
Description

Hematology: Date samples taken

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0460065
dd/MMM/yyyy
LAB Interpretation (If LAB Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
Description

Hematology: Laboratory interpretation

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0262707
LAB Test
Description

Hematology: Laboratory Tests

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0022885
LAB Interpretation
Description

Hematology: Laboratory interpretation specification

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0262707
UMLS CUI [1,3]
C2348235
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/ or Adverse Event form.
Description

Hematology: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0947611
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C0005477
Form Not Done
Description

Biochemistry

Data type

text

Alias
UMLS CUI [1]
C0005477
Were samples taken?
Description

Biochemistry: samples taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1277698
Date of Sample Taken
Description

Biochemistry: Date samples taken

Data type

date

Measurement units
  • dd/MMM/yyyy
Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0460065
dd/MMM/yyyy
LAB Interpretation (If LAB Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
Description

Biochemistry: Laboratory interpretation

Data type

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0262707
LAB Test
Description

Biochemistry: Laboratory Tests

Data type

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
LAB Interpretation
Description

Biochemistry: Laboratory interpretation Specification

Data type

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0262707
UMLS CUI [1,3]
C2348235
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/or Adverse Event form.
Description

Biochemistry: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0947611
Tolerability Assessment
Description

Tolerability Assessment

Alias
UMLS CUI-1
C3274448
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
Description

Tolerability Assessment

Data type

text

Alias
UMLS CUI [1]
C3274448
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
Description

Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
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Similar models

Unscheduled Event QTZ-EC-0004 ELEVATE NCT01713426

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Visit
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.)
boolean
C0545082 (UMLS CUI [1])
Date of visit
Item
If Yes, please provide the Date of Visit.
date
Item Group
Unscheduled Event Checklist
C3854240 (UMLS CUI-1)
C1707357 (UMLS CUI-2)
Item
Please select the procedures performed at this visit
text
C0184661 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Procedures at visit
Code List
Please select the procedures performed at this visit
CL Item
Physical Examination (Physical Examination)
CL Item
Vital Signs 1 (Vital Signs 1)
CL Item
Hematology (Hematology)
CL Item
Biochemistry (Biochemistry)
CL Item
Pregnancy (Pregnancy)
CL Item
Tolerability Assessment (Tolerability Assessment)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Form Not Done
text
C0031809 (UMLS CUI [1])
Physical Examination
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Physical Examination: Comment
Item
Record any abnormal findings/ conditions identified during the exam on the appropriate form. For Screening/ Baseline visits, report abnormal findings/ conditions on the appropriate form. For Screening/Baseline visits, report abnormal findings/ conditions on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal findings/conditions that have worsened from Screening/Baseline and are clinically significant on the Adverse Events form.
text
C0031809 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Item
Form Not Done
text
C0518766 (UMLS CUI [1])
Vital signs
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Item
Position
text
Position
Code List
Position
CL Item
Sitting (Sitting)
CL Item
Standing (Standing)
CL Item
Supine (Supine)
Systolic Blood Pressure
Item
Systolic Blood Pressure
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
float
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
float
C0232117 (UMLS CUI [1])
Vital Signs: Comment
Item
Record any abnormal results on the appropriate form. For Screening/Baseline visits, report abnormal results on the appropriate form (Medical History or Adverse Event). For Post-Baseline visits, record abnormal results that have worsened from Screening/ Baseline and are clinicallly significant on the Adverse Event form.
text
C0518766 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
text
C0032976 (UMLS CUI [1])
Pregnancy Test
Code List
Form Not Done (Mark Form Not Done only if the entire visit was not done, otherwise provide details below)
CL Item
Done  (Done )
CL Item
Not Done (Not Done)
Item
If Pregnancy Test was not done, please provide reason:
text
C0032976 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Pregnancy Test: Reason
Code List
If Pregnancy Test was not done, please provide reason:
CL Item
Female (2 years post-menopausal or surgically sterile) (Female (2 years post-menopausal or surgically sterile))
CL Item
Male (Male)
CL Item
Other (Other)
Pregnancy Test: Reason Specification
Item
If `Other`, specify:
text
C0032976 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Pregnancy Test: Date
Item
Date of Sample Taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of Pregnancy Test
text
C0427777 (UMLS CUI [1])
Pregnancy Test: Result
Code List
Result of Pregnancy Test
CL Item
Negative  (Negative )
CL Item
Positive (Positive)
Item Group
Hematology
C0474523 (UMLS CUI-1)
Item
Form Not Done
text
C0474523 (UMLS CUI [1])
Hematology
Code List
Form Not Done
CL Item
Done  (Done )
CL Item
Not Done (Not Done)
Hematology: samples taken
Item
Were samples taken?
boolean
C0474523 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Hematology: Date samples taken
Item
Date of Sample Taken
date
C0474523 (UMLS CUI [1,1])
C0460065 (UMLS CUI [1,2])
Item
LAB Interpretation (If LAB Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
text
C0474523 (UMLS CUI [1,1])
C0262707 (UMLS CUI [1,2])
Hematology: Laboratory interpretation
Code List
LAB Interpretation (If LAB Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
LAB Test
text
C0474523 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Hematology: Laboratory Tests
Code List
LAB Test
CL Item
Red Blood Cell (Red Blood Cell)
CL Item
White Blood Cell Count (White Blood Cell Count)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Neutrophils (Neutrophils)
CL Item
Eosinophils (Eosinophils)
CL Item
Basophils (Basophils)
CL Item
Monocytes (Monocytes)
CL Item
Hemoglobin (Hemoglobin)
CL Item
Hematocrit (Hematocrit)
CL Item
Platelets (Platelets)
Item
LAB Interpretation
text
C0474523 (UMLS CUI [1,1])
C0262707 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Hematology: Laboratory interpretation specification
Code List
LAB Interpretation
CL Item
Abnormal-not clinically significant (Abnormal-not clinically significant)
CL Item
Abnormal-clinically significant (Abnormal-clinically significant)
Hematology: Comment
Item
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/ or Adverse Event form.
text
C0474523 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Biochemistry
C0005477 (UMLS CUI-1)
Item
Form Not Done
text
C0005477 (UMLS CUI [1])
Biochemistry
Code List
Form Not Done
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Biochemistry: samples taken
Item
Were samples taken?
boolean
C0005477 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Biochemistry: Date samples taken
Item
Date of Sample Taken
date
C0005477 (UMLS CUI [1,1])
C0460065 (UMLS CUI [1,2])
Item
LAB Interpretation (If LAB Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
text
C0005477 (UMLS CUI [1,1])
C0262707 (UMLS CUI [1,2])
Hematology: Laboratory interpretation
Code List
LAB Interpretation (If LAB Interpretation is abnormal, please select assessment items below and report the interpretation for each.)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
LAB Test
text
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Biochemistry: Laboratory Tests
Code List
LAB Test
CL Item
AST (AST)
CL Item
ALT (ALT)
CL Item
Alkaline Phosphatase (Alkaline Phosphatase)
CL Item
TBL (TBL)
CL Item
Sodium (Sodium)
CL Item
Potassium (Potassium)
CL Item
BUN (BUN)
CL Item
Creatinine (Creatinine)
Item
LAB Interpretation
text
C0005477 (UMLS CUI [1,1])
C0262707 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Hematology: Laboratory interpretation
Code List
LAB Interpretation
CL Item
Abnormal-not clinically significant (Abnormal-not clinically significant)
CL Item
Abnormal-clinically significant (Abnormal-clinically significant)
Biochemistry: Comment
Item
Record any clinically significant abnormal findings/conditions identified during the exam on Medical and Surgical History and/or Adverse Event form.
text
C0005477 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Tolerability Assessment
C3274448 (UMLS CUI-1)
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
text
C3274448 (UMLS CUI [1])
Tolerability Assessment
Code List
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/ REGISTERED BUT NEVER RECEIVED/ DISPENSED STUDY DRUG`).
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Adverse Event
Item
Has diary been reviewed, and any existing Adverse Events recorded in the eCRF?
boolean
C0877248 (UMLS CUI [1])
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