0 Evaluaciones
ID

25699

Descripción

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Last Clinic Visit (Day 49)

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Versiones (1)
  1. 11/9/17 11/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC-ND 3.0
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    Last Clinic Visit GSK Ropinirole Restless Legs Syndrome 101468

    Inglés

    Last Clinic Visit GSK Ropinirole Restless Legs Syndrome 101468

    1 formularios  
    Patient Information
    Descripción

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1830427
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Day
    Descripción

    Visit Day

    Tipo de datos

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1]
    C2827038
    dd-mmm-yyyy
    Predose Checklist - Instructions: Please mark appropriate answer to the following questions. If the answer to all the questions is YES then dosing may proceed.
    Descripción

    Predose Checklist - Instructions: Please mark appropriate answer to the following questions. If the answer to all the questions is YES then dosing may proceed.

    Alias
    UMLS CUI-1
    C0439565
    UMLS CUI-2
    C1707357
    1. Has the patient refrained from consuming alcohol from midnight prior to the clinic visit?
    Descripción

    Last Alcohol Consumption

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C1517741
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, 1.5 ounces of hard liquor or 1 small glass of wine.)
    Descripción

    Alcohol consumption

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001948
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 24 hours before the clinic visit?
    Descripción

    Strenuous Exercise

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1514989
    4. Has the patient maintained their normal smoking practice?
    Descripción

    Smoking Status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    5. Has the patient refrained from caffeine-containing beverages from 12 noon on the day of the clinic visit?
    Descripción

    Caffeinated beverage

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0678438
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    Descripción

    OTC or herbal remedies

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0013231
    UMLS CUI [2]
    C0025125
    7. For the concomitant medication which are CYP1A2 inducers, substrated or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy or oestrogen containing medications)
    Descripción

    Concomitant Medication

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    RLS Rating Scale
    Descripción

    RLS Rating Scale

    Alias
    UMLS CUI-1
    C0681889
    UMLS CUI-2
    C0035258
    RLS Rating Scale
    Descripción

    RLS Rating Scale

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0681889
    UMLS CUI [1,2]
    C0035258
    Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
    Descripción

    Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439565
    Date
    Descripción

    Date of Examination: Pre-Dose

    Tipo de datos

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C2826643
    UMLS CUI [1,2]
    C0439565
    dd-mmm-yyyy
    Time
    Descripción

    Time of Examination: Pre-Dose

    Tipo de datos

    time

    Unidades de medida
    • 24hr:min
    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0439565
    24hr:min
    Semi-supine Blood Pressure: Systolic
    Descripción

    Semi-supine Systolic Blood Pressure: Pre-Dose

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0522019
    UMLS CUI [1,2]
    C0871470
    UMLS CUI [1,3]
    C0439565
    mmHg
    Semi-supine Blood Pressure: Diastolic
    Descripción

    Semi-supine Diastolic Blood Pressure: Pre-Dose

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0522019
    UMLS CUI [1,2]
    C0428883
    UMLS CUI [1,3]
    C0439565
    mmHg
    Semi-supine Heart Rate
    Descripción

    Semi-supine Heart Rate: Pre-Dose

    Tipo de datos

    float

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0522019
    UMLS CUI [1,2]
    C0018810
    UMLS CUI [1,3]
    C0439565
    bpm
    Erect Blood Pressure: Systolic
    Descripción

    Erect Systolic Blood Pressure: Pre-Dose

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0522014
    UMLS CUI [1,2]
    C0871470
    UMLS CUI [1,3]
    C0439565
    mmHg
    Erect Blood Pressure: Diastolic
    Descripción

    Erect Diastolic Blood Pressure: Pre-Dose

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0522014
    UMLS CUI [1,2]
    C0428883
    UMLS CUI [1,3]
    C0439565
    mmHg
    Erect Heart Rate
    Descripción

    Erect Heart Rate: Pre-Dose

    Tipo de datos

    float

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0522014
    UMLS CUI [1,2]
    C0018810
    bpm
    Dosing Details
    Descripción

    Dosing Details

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    Was afternoon meal/snack eaten before dosing?
    Descripción

    Afternoon meal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0439550
    UMLS CUI [1,2]
    C1998602
    Meal finish date:
    Descripción

    Date of last food intake

    Tipo de datos

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C0578574
    UMLS CUI [1,2]
    C0011008
    dd-mmm-yyyy
    Time of last food intake
    Descripción

    Time of last food intake

    Tipo de datos

    time

    Unidades de medida
    • 24hr:min
    Alias
    UMLS CUI [1]
    C0578574
    24hr:min
    Date of dosing
    Descripción

    Date of Dosing

    Tipo de datos

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0011008
    dd-mmm-yyyy
    Time of dosing
    Descripción

    Time of Dosing

    Tipo de datos

    time

    Unidades de medida
    • 24hr:min
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    24hr:min
    Please record the following details from the bottle: Container Number
    Descripción

    Container Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0180098
    Please remove the label from the medication carton and attach below:
    Descripción

    Label

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013191
    Dose Level
    Descripción

    Dose Level

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0178602
    Dose checked and administered by:
    Descripción

    Doctor's Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C0031831
    Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
    Descripción

    Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    Study Time: Repeat at:
    Descripción

    Study time: Post-Dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0439568
    Date
    Descripción

    Date of Examination: Post-Dose

    Tipo de datos

    date

    Unidades de medida
    • dd-mmm-yyyy
    Alias
    UMLS CUI [1,1]
    C2826643
    UMLS CUI [1,2]
    C0439568
    dd-mmm-yyyy
    Time
    Descripción

    Time of Examination: Post-Dose

    Tipo de datos

    time

    Unidades de medida
    • 24hr:min
    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0043299
    UMLS CUI [1,3]
    C0439568
    24hr:min
    Semi-supine Blood Pressure: Systolic
    Descripción

    Semi-supine Systolic Blood Pressure: Post-Dose

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0522019
    UMLS CUI [1,2]
    C0871470
    UMLS CUI [1,3]
    C0439568
    mmHg
    Semi-supine Blood Pressure: Diastolic
    Descripción

    Semi-supine Diastolic Blood Pressure: Post-Dose

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0522019
    UMLS CUI [1,2]
    C0428883
    UMLS CUI [1,3]
    C0439568
    mmHg
    Semi-supine Heart Rate
    Descripción

    Semi-supine Heart Rate: Post-Dose

    Tipo de datos

    float

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0522019
    UMLS CUI [1,2]
    C0018810
    UMLS CUI [1,3]
    C0439568
    bpm
    Erect Blood Pressure: Systolic
    Descripción

    Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.

    Tipo de datos

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0522014
    UMLS CUI [1,2]
    C0871470
    UMLS CUI [1,3]
    C0439568
    mmHg
    Erect Blood Pressure: Diastolic
    Descripción

    Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0522014
    UMLS CUI [1,2]
    C0428883
    UMLS CUI [1,3]
    C0439568
    Erect Heart Rate
    Descripción

    Repeat the erect measurements IMMEDIATELY if reading is technically invalid & discard inaccurate data, enter the repeat data in the CRF.

    Tipo de datos

    float

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1,1]
    C0522014
    UMLS CUI [1,2]
    C0018810
    UMLS CUI [1,3]
    C0439568
    bpm
    Alert Criteria (readings of potential clinical concern): Recording either a fall in systolic blood pressure of >30 mmHg or diastolic of 20 mmHg from semi-supine to an erect position, or a decrease of > 30 mmHg for systolic pressure or 20 mmHg for diastolic pressure from corresponding mean measurement taken at pre-dose. OR The patient reports orthostatic symptoms such as feeling faint of dizzy that fulfill criteria common toxicity grade (CTC) grade 2 or greater for hypotension
    Descripción

    Alert Criteria

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3665546
    UMLS CUI [1,2]
    C0243161
    Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.
    Descripción

    Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.

    Alias
    UMLS CUI-1
    C0877248
    Time Point: Repeat at:
    Descripción

    Time Point

    Tipo de datos

    text

    Any Adverse Events?
    Descripción

    * If 'YES' record all details on an Adverse Event page at back of CRF.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0877248
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    Similar models

    Last Clinic Visit GSK Ropinirole Restless Legs Syndrome 101468

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Day
    Item
    Visit Day
    date
    C2827038 (UMLS CUI [1])
    Item Group
    Predose Checklist - Instructions: Please mark appropriate answer to the following questions. If the answer to all the questions is YES then dosing may proceed.
    C0439565 (UMLS CUI-1)
    C1707357 (UMLS CUI-2)
    Last Alcohol Consumption
    Item
    1. Has the patient refrained from consuming alcohol from midnight prior to the clinic visit?
    boolean
    C0001948 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    Alcohol consumption
    Item
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, 1.5 ounces of hard liquor or 1 small glass of wine.)
    boolean
    C0001948 (UMLS CUI [1])
    Strenuous Exercise
    Item
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 24 hours before the clinic visit?
    boolean
    C1514989 (UMLS CUI [1])
    Smoking Status
    Item
    4. Has the patient maintained their normal smoking practice?
    boolean
    C1519386 (UMLS CUI [1])
    Caffeinated beverage
    Item
    5. Has the patient refrained from caffeine-containing beverages from 12 noon on the day of the clinic visit?
    boolean
    C0678438 (UMLS CUI [1])
    OTC or herbal remedies
    Item
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    boolean
    C0013231 (UMLS CUI [1])
    C0025125 (UMLS CUI [2])
    Concomitant Medication
    Item
    7. For the concomitant medication which are CYP1A2 inducers, substrated or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy or oestrogen containing medications)
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    RLS Rating Scale
    C0681889 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    RLS Rating Scale
    Item
    RLS Rating Scale
    text
    C0681889 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item Group
    Vital Signs - Instructions: Semi-supine recordings must be made after the patient has been resting semi-supine for at least 10 min & erect measurments will be taken after the patients has been erect for a period of 1 min. Three sets of stable semi-supine and errect vital signs must be recorded pre-dose with the patient resting fro 10 min semi-supine between each set. In this instance 'stable' is defined at all measurements being within 15 mmHg of the lowest measurements for each and every parameter e.g. semi-supine diastolic. - The blood pressure cuff must be placed on the same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
    C0518766 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    Date of Examination: Pre-Dose
    Item
    Date
    date
    C2826643 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    Time of Examination: Pre-Dose
    Item
    Time
    time
    C0040223 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C0439565 (UMLS CUI [1,3])
    Semi-supine Systolic Blood Pressure: Pre-Dose
    Item
    Semi-supine Blood Pressure: Systolic
    float
    C0522019 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    C0439565 (UMLS CUI [1,3])
    Semi-supine Diastolic Blood Pressure: Pre-Dose
    Item
    Semi-supine Blood Pressure: Diastolic
    float
    C0522019 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    C0439565 (UMLS CUI [1,3])
    Semi-supine Heart Rate: Pre-Dose
    Item
    Semi-supine Heart Rate
    float
    C0522019 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    C0439565 (UMLS CUI [1,3])
    Erect Systolic Blood Pressure: Pre-Dose
    Item
    Erect Blood Pressure: Systolic
    float
    C0522014 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    C0439565 (UMLS CUI [1,3])
    Erect Diastolic Blood Pressure: Pre-Dose
    Item
    Erect Blood Pressure: Diastolic
    float
    C0522014 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    C0439565 (UMLS CUI [1,3])
    Erect Heart Rate: Pre-Dose
    Item
    Erect Heart Rate
    float
    C0522014 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Item Group
    Dosing Details
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    Afternoon meal
    Item
    Was afternoon meal/snack eaten before dosing?
    boolean
    C0439550 (UMLS CUI [1,1])
    C1998602 (UMLS CUI [1,2])
    Date of last food intake
    Item
    Meal finish date:
    date
    C0578574 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of last food intake
    Item
    Time of last food intake
    time
    C0578574 (UMLS CUI [1])
    Date of Dosing
    Item
    Date of dosing
    date
    C0178602 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Dosing
    Item
    Time of dosing
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Container Number
    Item
    Please record the following details from the bottle: Container Number
    text
    C0180098 (UMLS CUI [1])
    Label
    Item
    Please remove the label from the medication carton and attach below:
    text
    C0013191 (UMLS CUI [1])
    Dose Level
    Item
    Dose Level
    text
    C0178602 (UMLS CUI [1])
    Doctor's Name
    Item
    Dose checked and administered by:
    text
    C0027365 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Item Group
    Vital Signs Instructions: For each set, semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 min & erect measurements will be taken after the patients has been erect for a period of 1 min. - The blood pressure cuff must be placed on same arm throughout the study. - The same study nurse/operator should conduct all the blood pressure measurements for each clinic visit.
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    Item
    Study Time: Repeat at:
    text
    C2348563 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Study time
    Code List
    Study Time: Repeat at:
    CL Item
    + 0.5 hrs (+ 0.5 hrs)
    CL Item
    + 1 hrs (+ 1 hrs)
    CL Item
    + 1.5 hrs (+ 1.5 hrs)
    CL Item
    + 2 hrs (+ 2 hrs)
    CL Item
    + 3 hrs (+ 3 hrs)
    CL Item
    + 4 hrs (+ 4 hrs)
    CL Item
    + 5 hrs (+ 5 hrs)
    CL Item
    + 6 hrs (+ 6 hrs)
    Date of Examination: Post-Dose
    Item
    Date
    date
    C2826643 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    Time of Examination: Post-Dose
    Item
    Time
    time
    C0040223 (UMLS CUI [1,1])
    C0043299 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Semi-supine Systolic Blood Pressure: Post-Dose
    Item
    Semi-supine Blood Pressure: Systolic
    float
    C0522019 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Semi-supine Diastolic Blood Pressure: Post-Dose
    Item
    Semi-supine Blood Pressure: Diastolic
    float
    C0522019 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Semi-supine Heart Rate: Post-Dose
    Item
    Semi-supine Heart Rate
    float
    C0522019 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Erect Systolic Blood Pressure: Post-Dose
    Item
    Erect Blood Pressure: Systolic
    float
    C0522014 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Erect Diastolic Blood Pressure: Post-Dose
    Item
    Erect Blood Pressure: Diastolic
    boolean
    C0522014 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Erect Heart Rate: Post-Dose
    Item
    Erect Heart Rate
    float
    C0522014 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    C0439568 (UMLS CUI [1,3])
    Alert Criteria
    Item
    Alert Criteria (readings of potential clinical concern): Recording either a fall in systolic blood pressure of >30 mmHg or diastolic of 20 mmHg from semi-supine to an erect position, or a decrease of > 30 mmHg for systolic pressure or 20 mmHg for diastolic pressure from corresponding mean measurement taken at pre-dose. OR The patient reports orthostatic symptoms such as feeling faint of dizzy that fulfill criteria common toxicity grade (CTC) grade 2 or greater for hypotension
    text
    C3665546 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    Item Group
    Adverse Event - Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis NOT symptoms where possible.
    C0877248 (UMLS CUI-1)
    Item
    Time Point: Repeat at:
    text
    Time Point
    Code List
    Time Point: Repeat at:
    CL Item
    + 2 hrs (+ 2 hrs)
    CL Item
    + 6 hrs (+ 6 hrs)
    CL Item
    Next Day (by telephone) (Next Day (by telephone))
    Adverse Event
    Item
    Any Adverse Events?
    boolean
    C0877248 (UMLS CUI [1])
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