Informatie:
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ID
16816
Beschrijving
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
Trefwoorden
Versies (1)
- 08-08-16 08-08-16 -
Geüploaded op
8 augustus 2016
DOI
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Licentie
Creative Commons BY-NC-ND 3.0
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Unscheduled Event QTZ-EC-0004 ELEVATE NCT01713426
Unscheduled Event QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Similar models
Unscheduled Event QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
C1707357 (UMLS CUI-2)
Item
Please select the procedures performed at this visit
text
C0184661 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
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)
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])
C0947611 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
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])
C0947611 (UMLS CUI [1,2])
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])
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])
C0392360 (UMLS CUI [1,2])
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])
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])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (Negative )
CL Item
Positive (Positive)
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])
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])
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])
C0262707 (UMLS CUI [1,2])
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)
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])
C0262707 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
C0947611 (UMLS CUI [1,2])
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])
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])
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])
C0262707 (UMLS CUI [1,2])
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])
C0022885 (UMLS CUI [1,2])
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])
C0262707 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
C0947611 (UMLS CUI [1,2])
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])
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])