Informatie:
Fout:
ID
16700
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)
- 01-08-16 01-08-16 -
Geüploaded op
1 augustus 2016
DOI
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Licentie
Creative Commons BY-NC-ND 3.0
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Baseline Visit QTZ-EC-0004 ELEVATE NCT01713426
Baseline Visit QTZ-EC-0004 ELEVATE NCT01713426
- StudyEvent: ODM
Similar models
Baseline Visit 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
Eligibility: Inclusion
Item
Is the subject fully eligible per the Inclusion Criteria?
boolean
C0013893 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
Item
If No, please list each Inclusion Criterion not met that makes the subject ineligible by adding as many log lines necessary.
text
C1512693 (UMLS CUI [1])
Code List
If No, please list each Inclusion Criterion not met that makes the subject ineligible by adding as many log lines necessary.
CL Item
1.Male or female between 18 and 80 years of age, inclusive (1.Male or female between 18 and 80 years of age, inclusive)
CL Item
2. In good health as determined by the investigator (2. In good health as determined by the investigator)
CL Item
3. Documented diagnosis of probable or definite PNP (Treede et al, 2008) (3. Documented diagnosis of probable or definite PNP (Treede et al, 2008))
CL Item
4. Localized and well-defined area of PNP, suitable for treatment with QUTENZA (4. Localized and well-defined area of PNP, suitable for treatment with QUTENZA)
CL Item
5a. Documented diagnosis at the Baseline Visit of either: a. PHN with pain persisting at least 6 months since shingles vesicle crusting (5a. Documented diagnosis at the Baseline Visit of either: a. PHN with pain persisting at least 6 months since shingles vesicle crusting)
CL Item
5b. PNI including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months (5b. PNI including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months)
CL Item
5c. Non-diabetic painful peripheral polyneuropathy with pain which has persisted for a minimum of 3 months, including I. small-fiber neuropathy, as confirmed by QST, laser evoked potentials (LEP), or skin biopsy, II. chemotherapy induced neuropathy in subjects with stable neoplastic disease, III. other, adequately characterized painful peripheral (5c. Non-diabetic painful peripheral polyneuropathy with pain which has persisted for a minimum of 3 months, including I. small-fiber neuropathy, as confirmed by QST, laser evoked potentials (LEP), or skin biopsy, II. chemotherapy induced neuropathy in subjects with stable neoplastic disease, III. other, adequately characterized painful peripheral)
CL Item
polyneuropathy, based on clinical history and examination (polyneuropathy, based on clinical history and examination)
CL Item
4 during screening period, over a minimum of at least 4 consecutive days (using the “average pain for the past 24 hours” (NPRS) score (6. Average pain score >)
CL Item
7. Intact, non-irritated, dry skin over the painful area(s) to be treated (7. Intact, non-irritated, dry skin over the painful area(s) to be treated)
CL Item
8a. Naïve to treatment with pregabalin and gabapentin (8a. Naïve to treatment with pregabalin and gabapentin)
CL Item
8b. In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin (8b. In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin)
CL Item
9. Subject is willing to receive pregabalin or QUTENZA as part of the trial. (9. Subject is willing to receive pregabalin or QUTENZA as part of the trial.)
CL Item
10. Females of child bearing potential must be willing to use highly effective methods of birth control during the study and for 30 days following study termination (a highly effective method of birth control is defined as those which result in a low failure rate (CHMP/ICH/286/95 modified) of less that 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner). (10. Females of child bearing potential must be willing to use highly effective methods of birth control during the study and for 30 days following study termination (a highly effective method of birth control is defined as those which result in a low failure rate (CHMP/ICH/286/95 modified) of less that 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner).)
CL Item
11. Willing and able to comply with protocol requirements for the duration of study participation (11. Willing and able to comply with protocol requirements for the duration of study participation)
CL Item
12. Given written informed consent (12. Given written informed consent)
Eligibility: Exclusion
Item
is the subject fully eligible per the Exclusion Criteria?
boolean
C0013893 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Item
If No, please list each Exclusion Criterion that makes the subject ineligible by adding as many log lines necessary.
text
C0680251 (UMLS CUI [1])
Code List
If No, please list each Exclusion Criterion that makes the subject ineligible by adding as many log lines necessary.
CL Item
1. Significant ongoing or recurrent pain of etiology other than PHN, PNI or non-diabetic painful peripheral polyneuropathy, for example: compression-related neuropathies (e.g. spinal stenosis), radiculopathy, tumor related pain, fibromyalgia or arthritis (1. Significant ongoing or recurrent pain of etiology other than PHN, PNI or non-diabetic painful peripheral polyneuropathy, for example: compression-related neuropathies (e.g. spinal stenosis), radiculopathy, tumor related pain, fibromyalgia or arthritis)
CL Item
2. Complex Regional Pain Syndrome (CRPS, Type I or II) (2. Complex Regional Pain Syndrome (CRPS, Type I or II))
CL Item
3. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN (3. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN)
CL Item
4. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes (4. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes)
CL Item
5. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation (5. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation)
CL Item
6. Reported daily pain score of 10 on the NPRS for at least 4 days during the screening period (6. Reported daily pain score of 10 on the NPRS for at least 4 days during the screening period)
CL Item
7. Past or current history of diabetes mellitus. (7. Past or current history of diabetes mellitus.)
CL Item
8. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the subject at risk of adverse cardiovascular reactions related to the patch application procedure (8. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the subject at risk of adverse cardiovascular reactions related to the patch application procedure)
CL Item
9. Creatinine clearance (CLcr) < 60mL/min according to the Cockcroft-Gault formula (9. Creatinine clearance (CLcr) < 60mL/min according to the Cockcroft-Gault formula)
CL Item
10. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria (10. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria)
CL Item
11. Severe ongoing depression according to DSM-IV or ICD-10 criteria (11. Severe ongoing depression according to DSM-IV or ICD-10 criteria)
CL Item
12. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete study evaluations and recall pain levels in the past 24 hours (12. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete study evaluations and recall pain levels in the past 24 hours)
CL Item
13. Planned elective surgery during the trial (13. Planned elective surgery during the trial)
CL Item
14. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit (14. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit)
CL Item
15. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial (15. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial)
CL Item
16. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, or adhesives (16. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, or adhesives)
CL Item
17. Treatment with pregabalin or gabapentin within 2 months prior to the Baseline Visit. (17. Treatment with pregabalin or gabapentin within 2 months prior to the Baseline Visit.)
CL Item
18. Hypersensitivity to pregabalin or any of the excipients (18. Hypersensitivity to pregabalin or any of the excipients)
CL Item
19. Use of opioids exceeding a total daily dose of morphine of 200 mg/day, or equivalent o r any intravenous opioids or tapentadol, regardless of dose, within 7 days preceding the Baseline Visit. (19. Use of opioids exceeding a total daily dose of morphine of 200 mg/day, or equivalent o r any intravenous opioids or tapentadol, regardless of dose, within 7 days preceding the Baseline Visit.)
CL Item
20. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas to be treated within 7 days preceding the Baseline Visit (20. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas to be treated within 7 days preceding the Baseline Visit)
CL Item
21. Chemotherapy within 3 months of the Baseline Visit, except maintenance hormone treatment (21. Chemotherapy within 3 months of the Baseline Visit, except maintenance hormone treatment)
CL Item
22. Use of any investigational agent within 30 days prior to Baseline Visit (22. Use of any investigational agent within 30 days prior to Baseline Visit)
CL Item
23. Active substance abuse or history of chronic substance abuse within 1 year prior to screening; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator (23. Active substance abuse or history of chronic substance abuse within 1 year prior to screening; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator)
CL Item
24. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment (24. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment)
CL Item
25. Subject, who in th eopinion of the investigator, is not suitable for the study for any reason. (25. Subject, who in th eopinion of the investigator, is not suitable for the study for any reason.)
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 (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)
Scheduled Time
Item
Scheduled Time (Within 15 minutes before topical anaesthetic application)
boolean
C0086960 (UMLS CUI [1])
Vital signs: Assessment Date
Item
Assessment Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Vital signs: Assessment Time
Item
Assessment Time (00:00 - 23:59)
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Supine (Supine)
CL Item
Sitting (Sitting)
CL Item
Standing (Standing)
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])
Vitals signs: Comment
Item
Record any abnormal results on the appropriate form. For Screening/ Baseline visits, report abnormal resutls on the appropriate form (Medical History or Adverse Events). For Post-Baseline visits, record abnormal results that have worsened from Screening/ Baseline and are clinically significant on the Adverse Events form.
text
C0518766 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Height and Weight: Assessment Date
Item
Assessment Date
date
C0005890 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
C2985720 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
BMI
Item
BMI
text
C1305855 (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])
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)
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Qutenza (Qutenza)
CL Item
Pregabalin (Pregabalin)
Date of First Study Drug Taken
Item
Date of First Study Drug Taken
date
C3899436 (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
C2032736 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0392747 (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`.)
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Painful Area: Change since Screening visit
Item
Is there any change in the painful area since Screening visit?
boolean
C2032736 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C1409616 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,2])
C1409616 (UMLS CUI [1,3])
Painful Area: Change Specification
Item
If "Yes", please provide details on "Identifacation of Painful Area".
text
C2032736 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Form Not Done (Form Not Done should only be marked for subjects that are `RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG`.)
text
C2032736 (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)
Painful Area: Assessment Date
Item
Assessment Date
date
C2032736 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item
Treatment area: Plase tick all that apply
text
C0087111 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,2])
CL Item
Arms (Arms)
CL Item
Feet (Feet)
CL Item
Hands (Hands)
CL Item
Head and Neck (Head and Neck)
CL Item
Legs (Legs)
CL Item
Torso (Torso)
Painful Area: Size
Item
Total Painful/ Sensitive area Size
float
C2032736 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
CL Item
Done (Done )
CL Item
Not Done (Not Done)
Item
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
integer
C0522510 (UMLS CUI [1])
Code List
Intensity of dynamic mechanical allodynia (0=No Pain; 10=Pain as bad as patient can imagine)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
CL Item
6 (7)
CL Item
7 (8)
CL Item
8 (9)
CL Item
9 (10)
CL Item
10 (11)
Dynamic Mechanical Allodynia: Size
Item
Total surface area size of area of dynamic mechanical allodynia
float
C0522510 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (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
C1704738 (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)
Number of contacts for Neuropathic Pains
Item
Number of contacts with a healthcare professional related to neuropathic pain, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C3714625 (UMLS CUI [1,3])
Number of contacts: Specification
Item
Number of contacts with a healthcare professional for other causes, since the last visit
float
C1444281 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Application of Topical Anesthetic
C0185125 (UMLS CUI-1)
C0040464 (UMLS CUI-2)
C0040464 (UMLS CUI-2)
Item
Form Not Done
text
C0185125 (UMLS CUI [1,1])
C0040464 (UMLS CUI [1,2])
C0040464 (UMLS CUI [1,2])
CL Item
Done (Done)
CL Item
Not Done (Not Done)
Medication
Item
Medication
text
C0013227 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Dose Unit
Item
Dose Unit
text
C2826646 (UMLS CUI [1])
CL Item
Oral (Oral)
CL Item
Intravenous (Intravenous)
CL Item
Topical (Topical)
CL Item
Nasogastric (Nasogastric)
CL Item
Subcutaneous (Subcutaneous)
CL Item
Intramuscular (Intramuscular)
CL Item
Auricular (Otic) (Auricular (Otic))
CL Item
Ophthalmic (Ophthalmic)
CL Item
Sublingual (Sublingual)
CL Item
Respiratory (Inhalation) (Respiratory (Inhalation))
CL Item
Nasal (Nasal)
CL Item
Transdermal (Transdermal)
CL Item
Vaginal (Vaginal)
CL Item
Rectal (Rectal)
CL Item
Epidural (Epidural)
CL Item
Intrathecal (Intrathecal)
CL Item
Intra-Articular (Intra-Articular)
CL Item
Periarticular (Periarticular)
CL Item
Intraperitoneal (Intraperitoneal)
CL Item
Intradermal (Intradermal)
CL Item
Intra-arterial (Intra-arterial)
CL Item
Urethral (Urethral)
CL Item
Other (Other)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time (00:00 - 23:59)
time
C1301880 (UMLS CUI [1])
Stop Time
Item
Stop Time (00:00 - 23:59)
time
C1522314 (UMLS CUI [1])
Item Group
Application of Qutenza
C0185125 (UMLS CUI-1)
C2725082 (UMLS CUI-2)
C2725082 (UMLS CUI-2)
Qutenza: Start Date
Item
Start Date
date
C2725082 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Qutenza: Start Time
Item
Start Time (00:00 - 23:59) (Start time is when first patch is applied)
time
C2725082 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Qutenza: Stop Time
Item
Stop Time (00:00 - 23:59) (When all study patches have been removed, record the time of patch removal)
text
C2725082 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Treatment Area
text
C2725082 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
CL Item
Head and Neck (Head and Neck)
CL Item
Arms (Arms)
CL Item
Hands (Hands)
CL Item
Torso (Torso)
CL Item
Legs (Legs)
CL Item
Feet (Feet)
Qutenza: Treatment Area Size
Item
Treatment Area Size
float
C2725082 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Qutenza: Visual Estimated Percentage
Item
Visual Estimate of % used for each patch (0 - 100%)
float
C2725082 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0750572 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Qutenza: Treatment Patch Number
Item
Treatment Patch No. (1 - 4)
float
C2725082 (UMLS CUI [1,1])
C0991556 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0991556 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Qutenza: Treatment Patch Percentage
Item
Treatment Patch Percentage
float
C2725082 (UMLS CUI [1,1])
C0991556 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0991556 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
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])