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16790

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

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  1. 07.08.16 07.08.16 -
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7. August 2016

DOI

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    Cumulative QTZ-EC-0004 ELEVATE NCT01713426

    Englisch

    Cumulative QTZ-EC-0004 ELEVATE NCT01713426

    1 Formulare  
    Previous and Concomitant Medication
    Beschreibung

    Previous and Concomitant Medication

    Alias
    UMLS CUI-1
    C0013227
    Form Not Done (Form Not Done should only be akred for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
    Beschreibung

    Medication

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013227
    Are there any previous medications (concomitant treatment taken within 30 days of the Screening Visit) and/or concomitant medications to record?
    Beschreibung

    Previous and concomitant medication

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    UMLS CUI [2]
    C2347852
    Did the patient receive treatment with Pregabalin or Gabapentin at any time prior to the screening visit? (If Yes, please record treatment details below and also provide justificatin of inadequate trial)
    Beschreibung

    Pregabalin or Gabapentin

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0657912
    UMLS CUI [2]
    C0060926
    For previous use of Pregabalin or Gabapentin, specify the justification of inadequate trial:
    Beschreibung

    Pregabalin or Gabapentin: Justificaation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0657912
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [2,1]
    C0060926
    UMLS CUI [2,2]
    C0566251
    Medication
    Beschreibung

    Medication: Specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2348235
    Route
    Beschreibung

    Administration Route

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    If "Other", specify:
    Beschreibung

    Medication: Other

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0205394
    Start Date
    Beschreibung

    Start Date

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C0808070
    dd/MMM/yyyy
    Ongoing
    Beschreibung

    Ongoing

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0549178
    Stop Date
    Beschreibung

    Stop Date

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C0806020
    dd/MMM/yyyy
    Pain Medication (If Pain Medication is Yes, please select one of below options.)
    Beschreibung

    Pain Medication

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0002771
    Medication to treat neuropathic pain - chronic treatment
    Beschreibung

    Pain Medication: Neuropathic Pain Chronic

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0002771
    UMLS CUI [1,2]
    C3714625
    UMLS CUI [1,3]
    C0205191
    Medication to treat neuropathic pain - acute treatment
    Beschreibung

    Pain Medication: Neuropathic Pain Acute

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0002771
    UMLS CUI [1,2]
    C3714625
    UMLS CUI [1,3]
    C0205178
    Medication to treat post-application pain (QUTENZA arm only)
    Beschreibung

    Pain Medication: Post-application pain

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0002771
    UMLS CUI [1,2]
    C0185125
    Medication to treat non-neuropathic pain
    Beschreibung

    Pain Medication: Non-Neuropathic Pain

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0002771
    UMLS CUI [1,2]
    C1518422
    UMLS CUI [1,3]
    C3714625
    Indication
    Beschreibung

    Indication

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3146298
    Total Daily Dose
    Beschreibung

    Total Daily Dose

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C2348070
    Dose Unit
    Beschreibung

    Dose Unit

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826646
    If "Other", specify:
    Beschreibung

    Dose Unit: Specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826646
    UMLS CUI [1,2]
    C2348235
    Non-Medication Therapy
    Beschreibung

    Non-Medication Therapy

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C1518422
    Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
    Beschreibung

    Non-Medication Therapy Performed

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C1518422
    UMLS CUI [1,4]
    C0884358
    Is there any non-medication therapy and/or changes in non-medication therapy to record?
    Beschreibung

    Non-Medication Therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C1518422
    Therapy Details:
    Beschreibung

    Therapy Details

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1522508
    Start Date of Therapy
    Beschreibung

    Start Date of Therapy

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C3173309
    dd/MMM/yyyy
    Ongoing
    Beschreibung

    Ongoing

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0549178
    Stop Date of Therapy
    Beschreibung

    Stop Date of Therapy

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C1707480
    dd/MMM/yyyy
    Pain related non-medication therapy
    Beschreibung

    Pain related non-medication therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0013227
    UMLS CUI [1,4]
    C1518422
    Reason for Use
    Beschreibung

    Reason

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0392360
    If "Other", specify:
    Beschreibung

    Reason: Specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C2348235
    Adverse Event
    Beschreibung

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Form Not Done (Form Not Done should only be marked for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG".)
    Beschreibung

    Adverse Event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0877248
    Were any adverse events reported or observed?
    Beschreibung

    Adverse Event: Report

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0684224
    Adverse Event
    Beschreibung

    Adverse Event: Specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2348235
    Onset Date
    Beschreibung

    Onset Date

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C0574845
    dd/MMM/yyyy
    Onset Time (00:00 - 23:59)
    Beschreibung

    Onset Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0449244
    If the onset date is the same day as study drug start date or if a complete onset is unknown and/or if the date and time are unknown, please select one.
    Beschreibung

    Onset Date: Specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C2348235
    End Date
    Beschreibung

    End Date

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C0806020
    dd/MMM/yyyy
    End Time (00:00 - 23:59)
    Beschreibung

    End Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C1522314
    Outcome (If "Outcome" is FATAL, complete the "Adverse Events" form.)
    Beschreibung

    Adverse Event: Outcome

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1705586
    Course of Event
    Beschreibung

    Course of Event

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0750729
    Severity
    Beschreibung

    Adverse Event: Severity

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1710066
    Serious AE? (If "Serious AE?" is Yes, select all that apply.) (In case of a serious adverse event (SAE), complete a SAE report)
    Beschreibung

    Serious Adverse Event

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Serious Adverse Event Number
    Beschreibung

    Serious Adverse Event: Number

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Death
    Beschreibung

    Death

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011065
    Requires or prolongs hospitalization
    Beschreibung

    Hospitalization

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    Congenital anomaly
    Beschreibung

    Congenital anomaly

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826727
    Life-threatening
    Beschreibung

    Life-threatening

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826244
    Persistent or significant disability/Incapacity
    Beschreibung

    Disability

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0231170
    Other medical importance
    Beschreibung

    Medical Importance

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205476
    UMLS CUI [1,2]
    C1705104
    Action Taken for Study Drug (If "Action Taken for Study Drug" is DRUG WITHDRAWN, complete the "End of Treatment and Study" form/ "End of Treatment" form.
    Beschreibung

    Action Taken: Study Drug

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826626
    Was there any treatment required? (If Yes, please select all that apply.)
    Beschreibung

    Adverse Event: Treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Medication Therapy (If "Medication Therapy" is Yes, complete the "Previous and Concomitant Medications" form.)
    Beschreibung

    Adverse Event: Medication Therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0013227
    Non-Medication Therapy (If "Non-Medication Therapy" is Yes, complete the "Non-Medication Therapy" form.)
    Beschreibung

    Adverse Event: Non-Medication Therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0013227
    UMLS CUI [1,4]
    C1518422
    Relationship to Study Drug
    Beschreibung

    Adverse Event: Study Drug

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0304229
    Please confirm if the Adverse Event is an Application site reaction.
    Beschreibung

    Adverse Event: Application site reaction

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0151505
    Date Serious Adverse Event Reconciled (For Astellas Use Only!)
    Beschreibung

    Serious Adverse Event: Date

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0011008
    dd/MMM/yyyy
    Administration of Pregabalin
    Beschreibung

    Administration of Pregabalin

    Alias
    UMLS CUI-1
    C0657912
    UMLS CUI-2
    C1533734
    Form Not Done (Please record every change in the dosing of Pregabalin in a new log line, providing Start and Stop Date)
    Beschreibung

    Administration of Pregabalin

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0657912
    UMLS CUI [1,2]
    C1533734
    Dosing Start Date
    Beschreibung

    Dosing Start Date

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C3173309
    dd/MMM/yyyy
    Dosing Stop Date
    Beschreibung

    Dosing Stop Date

    Datentyp

    date

    Maßeinheiten
    • dd/MMM/yyyy
    Alias
    UMLS CUI [1]
    C1115730
    dd/MMM/yyyy
    # of Total Capsules Taken Daily
    Beschreibung

    Total Capsules: Daily amount

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C0006935
    UMLS CUI [1,2]
    C2826638
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    Ähnliche Modelle

    Cumulative QTZ-EC-0004 ELEVATE NCT01713426

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Previous and Concomitant Medication
    C0013227 (UMLS CUI-1)
    Item
    Form Not Done (Form Not Done should only be akred for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
    text
    C0013227 (UMLS CUI [1])
    Medication
    Code List
    Form Not Done (Form Not Done should only be akred for subjects that are "RANDOMIZED/REGISTERED BUT NEVER RECEIVED/DISPENSED STUDY DRUG").
    CL Item
    Done (Done)
    CL Item
    Not Done (Not Done)
    Previous and concomitant medication
    Item
    Are there any previous medications (concomitant treatment taken within 30 days of the Screening Visit) and/or concomitant medications to record?
    boolean
    C2826667 (UMLS CUI [1])
    C2347852 (UMLS CUI [2])
    Pregabalin or Gabapentin
    Item
    Did the patient receive treatment with Pregabalin or Gabapentin at any time prior to the screening visit? (If Yes, please record treatment details below and also provide justificatin of inadequate trial)
    boolean
    C0657912 (UMLS CUI [1])
    C0060926 (UMLS CUI [2])
    Pregabalin or Gabapentin: Justificaation
    Item
    For previous use of Pregabalin or Gabapentin, specify the justification of inadequate trial:
    text
    C0657912 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0060926 (UMLS CUI [2,1])
    C0566251 (UMLS CUI [2,2])
    Medication: Specification
    Item
    Medication
    text
    C0013227 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Administration Route
    Code List
    Route
    CL Item
    Oral (Oral)
    CL Item
    Intravenous (Intravenous)
    CL Item
    Topical (Topical)
    CL Item
    Nasogastric (Nasogastric)
    CL Item
    Subcutaneaous (Subcutaneaous)
    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)
    Medication: Other
    Item
    If "Other", specify:
    text
    C0013227 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Ongoing
    Item
    Ongoing
    boolean
    C0549178 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Pain Medication
    Item
    Pain Medication (If Pain Medication is Yes, please select one of below options.)
    boolean
    C0002771 (UMLS CUI [1])
    Pain Medication: Neuropathic Pain Chronic
    Item
    Medication to treat neuropathic pain - chronic treatment
    boolean
    C0002771 (UMLS CUI [1,1])
    C3714625 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    Pain Medication: Neuropathic Pain Acute
    Item
    Medication to treat neuropathic pain - acute treatment
    boolean
    C0002771 (UMLS CUI [1,1])
    C3714625 (UMLS CUI [1,2])
    C0205178 (UMLS CUI [1,3])
    Pain Medication: Post-application pain
    Item
    Medication to treat post-application pain (QUTENZA arm only)
    boolean
    C0002771 (UMLS CUI [1,1])
    C0185125 (UMLS CUI [1,2])
    Pain Medication: Non-Neuropathic Pain
    Item
    Medication to treat non-neuropathic pain
    boolean
    C0002771 (UMLS CUI [1,1])
    C1518422 (UMLS CUI [1,2])
    C3714625 (UMLS CUI [1,3])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    float
    C2348070 (UMLS CUI [1])
    Item
    Dose Unit
    text
    C2826646 (UMLS CUI [1])
    Dose Unit
    Code List
    Dose Unit
    CL Item
    ug (ug)
    CL Item
    ug/h (ug/h)
    CL Item
    mg (mg)
    CL Item
    g (g)
    CL Item
    Other (Other)
    Item
    If "Other", specify:
    text
    C2826646 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Dose Unit
    Code List
    If "Other", specify:
    Item Group
    Non-Medication Therapy
    C0087111 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C1518422 (UMLS CUI-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
    C0087111 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C1518422 (UMLS CUI [1,3])
    C0884358 (UMLS CUI [1,4])
    Non-Medication Therapy
    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)
    Non-Medication Therapy
    Item
    Is there any non-medication therapy and/or changes in non-medication therapy to record?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C1518422 (UMLS CUI [1,3])
    Therapy Details
    Item
    Therapy Details:
    text
    C0087111 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    Start Date of Therapy
    Item
    Start Date of Therapy
    date
    C3173309 (UMLS CUI [1])
    Ongoing
    Item
    Ongoing
    boolean
    C0549178 (UMLS CUI [1])
    Stop Date of Therapy
    Item
    Stop Date of Therapy
    date
    C1707480 (UMLS CUI [1])
    Pain related non-medication therapy
    Item
    Pain related non-medication therapy
    boolean
    C0030193 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    C1518422 (UMLS CUI [1,4])
    Item
    Reason for Use
    text
    C0392360 (UMLS CUI [1])
    Reason
    Code List
    Reason for Use
    CL Item
    Neuropathic Pain (Neuropathic Pain)
    CL Item
    Post Patch Application Pain (Post Patch Application Pain)
    CL Item
    Other Pain (Other Pain)
    Item
    If "Other", specify:
    text
    C0392360 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Reason
    Code List
    If "Other", specify:
    Item Group
    Adverse Event
    C0877248 (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
    C0877248 (UMLS CUI [1])
    Adverse Event
    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: Report
    Item
    Were any adverse events reported or observed?
    boolean
    C0877248 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    Adverse Event: Specification
    Item
    Adverse Event
    text
    C0877248 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Onset Date
    Item
    Onset Date
    date
    C0574845 (UMLS CUI [1])
    Onset Time
    Item
    Onset Time (00:00 - 23:59)
    time
    C0449244 (UMLS CUI [1])
    Item
    If the onset date is the same day as study drug start date or if a complete onset is unknown and/or if the date and time are unknown, please select one.
    text
    C0574845 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Onset Date: Specification
    Code List
    If the onset date is the same day as study drug start date or if a complete onset is unknown and/or if the date and time are unknown, please select one.
    CL Item
    Onset before first dose of study drug (Onset before first dose of study drug)
    CL Item
    Onset after first dose of study drug (Onset after first dose of study drug)
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1])
    End Time
    Item
    End Time (00:00 - 23:59)
    time
    C1522314 (UMLS CUI [1])
    Item
    Outcome (If "Outcome" is FATAL, complete the "Adverse Events" form.)
    text
    C1705586 (UMLS CUI [1])
    Adverse Event: Outcome
    Code List
    Outcome (If "Outcome" is FATAL, complete the "Adverse Events" form.)
    CL Item
    Recovered/Resolved (Recovered/Resolved)
    CL Item
    Recovering/Resolving (Recovering/Resolving)
    CL Item
    Not recovered/not resolved (Not recovered/not resolved)
    CL Item
    Recovered/Resolved with sequelae (Recovered/Resolved with sequelae)
    CL Item
    Fatal (Fatal)
    CL Item
    Unknown (Unknown)
    Item
    Course of Event
    text
    C0750729 (UMLS CUI [1])
    Course of Event
    Code List
    Course of Event
    CL Item
    Single Episode (Single Episode)
    CL Item
    Intermittent (Intermittent)
    CL Item
    Continuous (Continuous)
    Item
    Severity
    text
    C1710066 (UMLS CUI [1])
    Adverse Event: Severity
    Code List
    Severity
    CL Item
    Mild (Mild)
    CL Item
    Moderate (Moderate)
    CL Item
    Severe (Severe)
    Serious Adverse Event
    Item
    Serious AE? (If "Serious AE?" is Yes, select all that apply.) (In case of a serious adverse event (SAE), complete a SAE report)
    boolean
    C1519255 (UMLS CUI [1])
    Serious Adverse Event: Number
    Item
    Serious Adverse Event Number
    float
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Death
    Item
    Death
    boolean
    C0011065 (UMLS CUI [1])
    Hospitalization
    Item
    Requires or prolongs hospitalization
    boolean
    C0019993 (UMLS CUI [1])
    Congenital anomaly
    Item
    Congenital anomaly
    boolean
    C2826727 (UMLS CUI [1])
    Life-threatening
    Item
    Life-threatening
    boolean
    C2826244 (UMLS CUI [1])
    Disability
    Item
    Persistent or significant disability/Incapacity
    boolean
    C0231170 (UMLS CUI [1])
    Medical Importance
    Item
    Other medical importance
    boolean
    C0205476 (UMLS CUI [1,1])
    C1705104 (UMLS CUI [1,2])
    Item
    Action Taken for Study Drug (If "Action Taken for Study Drug" is DRUG WITHDRAWN, complete the "End of Treatment and Study" form/ "End of Treatment" form.
    text
    C2826626 (UMLS CUI [1])
    Action Taken: Study Drug
    Code List
    Action Taken for Study Drug (If "Action Taken for Study Drug" is DRUG WITHDRAWN, complete the "End of Treatment and Study" form/ "End of Treatment" form.
    CL Item
    Dose not changed (Dose not changed)
    CL Item
    Dose increased (Dose increased)
    CL Item
    Dose reduced (Dose reduced)
    CL Item
    Drug interrupted (Drug interrupted)
    CL Item
    Drug withdrawn (Drug withdrawn)
    CL Item
    Unknown (Unknown)
    CL Item
    Not applicable (Not applicable)
    Adverse Event: Treatment
    Item
    Was there any treatment required? (If Yes, please select all that apply.)
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Adverse Event: Medication Therapy
    Item
    Medication Therapy (If "Medication Therapy" is Yes, complete the "Previous and Concomitant Medications" form.)
    boolean
    C0877248 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Adverse Event: Non-Medication Therapy
    Item
    Non-Medication Therapy (If "Non-Medication Therapy" is Yes, complete the "Non-Medication Therapy" form.)
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    C1518422 (UMLS CUI [1,4])
    Item
    Relationship to Study Drug
    text
    C0877248 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Adverse Event: Study Drug
    Code List
    Relationship to Study Drug
    CL Item
    Not related (Not related)
    CL Item
    Possible (Possible)
    CL Item
    Probable (Probable)
    Adverse Event: Application site reaction
    Item
    Please confirm if the Adverse Event is an Application site reaction.
    boolean
    C0877248 (UMLS CUI [1,1])
    C0151505 (UMLS CUI [1,2])
    Serious Adverse Event: Date
    Item
    Date Serious Adverse Event Reconciled (For Astellas Use Only!)
    date
    C1519255 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Administration of Pregabalin
    C0657912 (UMLS CUI-1)
    C1533734 (UMLS CUI-2)
    Item
    Form Not Done (Please record every change in the dosing of Pregabalin in a new log line, providing Start and Stop Date)
    text
    C0657912 (UMLS CUI [1,1])
    C1533734 (UMLS CUI [1,2])
    Administration of Pregabalin
    Code List
    Form Not Done (Please record every change in the dosing of Pregabalin in a new log line, providing Start and Stop Date)
    CL Item
    Done (Done)
    CL Item
    Not Done (Not Done)
    Dosing Start Date
    Item
    Dosing Start Date
    date
    C3173309 (UMLS CUI [1])
    Dosing Stop Date
    Item
    Dosing Stop Date
    date
    C1115730 (UMLS CUI [1])
    Total Capsules: Daily amount
    Item
    # of Total Capsules Taken Daily
    float
    C0006935 (UMLS CUI [1,1])
    C2826638 (UMLS CUI [1,2])
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