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24042

Beschreibung

Module 2 - Screening & Repeat Tests 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

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  1. 23.07.17 23.07.17 -
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GlaxoSmithKline

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23. Juli 2017

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    GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

    Englisch

    GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

    1 Formulare  
    Vital signs
    Beschreibung

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Pulse
    Beschreibung

    after 5 minutes sitting

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Sitting systolic Blood Pressure
    Beschreibung

    after 5 minutes sitting

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting diastolic blood pressure
    Beschreibung

    after 5 min sitting

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Laboratory Evaluation
    Beschreibung

    Laboratory Evaluation

    Alias
    UMLS CUI-1
    C0022877
    Date of blood sample
    Beschreibung

    Date of blood sample

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Please affix the Quest Diagnostics Laboratory label here.
    Beschreibung

    (Affix label only if sample was sent to Quest)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C4273937
    Were any clinically significant abnormalities detected?
    Beschreibung

    If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C1704258
    Urine Dipstick
    Beschreibung

    Urine Dipstick

    Alias
    UMLS CUI-1
    C0430370
    What was the result of the urine dipstick performed at this visit?
    Beschreibung

    If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
    Pregnancy dipstick
    Beschreibung

    Pregnancy dipstick

    Alias
    UMLS CUI-1
    C0430056
    Is the patient a female of child-bearing potential?
    Beschreibung

    If ’Yes’, please perform a pregnancy dipstick test and record result below.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1960468
    Pregnancy dipstick result
    Beschreibung

    If previous question was answered "yes", please perform a pregnancy dipstick test and record result below. If ’Positive’, please record details on the pregnancy form and exclude the patient.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C0456984
    Medical Procedures
    Beschreibung

    Medical Procedures

    Alias
    UMLS CUI-1
    C0199171
    Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
    Beschreibung

    If 'Yes', please record details below using standard medical terminology

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0199171
    UMLS CUI [2]
    C0087111
    UMLS CUI [3]
    C0430022
    UMLS CUI [4]
    C0543467
    Medical Procedures
    Beschreibung

    Medical Procedures

    Alias
    UMLS CUI-1
    C0199171
    Procedure
    Beschreibung

    Procedure

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0199171
    Indication
    Beschreibung

    Indication of medical procedure

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0199171
    UMLS CUI [1,2]
    C3146298
    Procedure Start Date
    Beschreibung

    Procedure Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0199171
    UMLS CUI [1,2]
    C0808070
    End Date Procedure
    Beschreibung

    End Date Procedure

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0199171
    UMLS CUI [1,2]
    C0806020
    Prior and concomitant medication
    Beschreibung

    Prior and concomitant medication

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
    Beschreibung

    If ‘Yes’, please record details below (Please print clearly)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2826257
    UMLS CUI [1,2]
    C2347852
    prior and concomitant medication
    Beschreibung

    prior and concomitant medication

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    Drug Name (Trade name preferred)
    Beschreibung

    Drug name

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0919189
    Total daily dose
    Beschreibung

    eg. 500 mg

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348070
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    Beschreibung

    or symptom in absence of diagnosis

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0011900
    Start Date (be as precise as possible)
    Beschreibung

    start date of medication

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End Date
    Beschreibung

    End Date of medication

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Does the medication still continue?
    Beschreibung

    medication is current

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0521116
    Baseline signs and symptoms
    Beschreibung

    Baseline signs and symptoms

    Alias
    UMLS CUI-1
    C0037088
    UMLS CUI-2
    C1442488
    Please mark this box if no baseline events occurred prior to randomisation into study.
    Beschreibung

    Baseline adverse reaction

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    Baseline event
    Beschreibung

    Record any baseline events (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way in the last 7 days?” Provide the diagnosis, not symptoms where possible. One baseline event per column.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C1442488
    Onset Date and Time
    Beschreibung

    Adverse Reaction Start Date Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C2981441
    UMLS CUI [1,2]
    C1442488
    End Date and Time
    Beschreibung

    (If ongoing please leave blank)

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C2981425
    UMLS CUI [1,2]
    C1442488
    Outcome
    Beschreibung

    If patient died, STOP: go to SAE section and follow instructions given there

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C1624730
    Event Course
    Beschreibung

    adverse reaction course

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C0750729
    Number of episodes
    Beschreibung

    only answer if previous answer was 'intermittent'

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C4086638
    Intensity (maximum)
    Beschreibung

    Intensity concerning the maximum

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C0518690
    Relationship to study procedures performed prior to enrolment
    Beschreibung

    Relationship to study procedures

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1510821
    Corrective Therapy
    Beschreibung

    If ‘Yes’, record details in Prior and Concomitant Medication section and/or Resource Utilisation section if appropriate

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C0087111
    Was patient withdrawn due to this specific event prior to randomisation?
    Beschreibung

    Study subject participation status due to adverse reaction

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0559546
    UMLS CUI [1,3]
    C0424092
    Significant medical/surgical history and physical examination
    Beschreibung

    Significant medical/surgical history and physical examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-3
    C0489540
    UMLS CUI-5
    C0031809
    Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
    Beschreibung

    If 'Yes' , please list below one diagnosis per line.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [2,1]
    C0543467
    UMLS CUI [2,2]
    C0008976
    Significant medical/surgical history and physical examination
    Beschreibung

    Significant medical/surgical history and physical examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0489540
    UMLS CUI-3
    C0031809
    Diagnosis
    Beschreibung

    Diagnosis

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0011900
    Year of first diagnosis (if know)
    Beschreibung

    Year of diagnosis

    Datentyp

    partialDate

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0439234
    Past and/or ongoing (diagnosis)
    Beschreibung

    Past and/or ongoing medical history

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0455458
    UMLS CUI [2]
    C2826680
    Patient continuation/ withdrawal
    Beschreibung

    Patient continuation/ withdrawal

    Alias
    UMLS CUI-1
    C2348568
    Is the patient continuing in the study?
    Beschreibung

    If ’Yes’, please place this Module in the CRF (Book 1) If ’No’, please mark the primary cause of withdrawal. (Mark one box only).

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0549178
    Cause of withdrawal from study
    Beschreibung

    Cause of withdrawal from study

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0085978
    Please specify 'other' cause of withdrawal from study.
    Beschreibung

    Other cause of withdrawal from study

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0205394
    Investigator signature
    Beschreibung

    Investigator signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator signature
    Beschreibung

    I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Baseline Signs and Symptoms and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Beschreibung

    Investigator Signature Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Repeated Laboratory Evaluation
    Beschreibung

    Repeated Laboratory Evaluation

    Alias
    UMLS CUI-1
    C0022877
    UMLS CUI-2
    C0205341
    Date of blood sample
    Beschreibung

    Date of blood sample

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Please affix the Quest Diagnostics Laboratory label here.
    Beschreibung

    Affix label only if sample was sent to Quest

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C4273937
    Were any clinically significant abnormalities detected?
    Beschreibung

    If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C1704258
    Repeated Urine dipstick
    Beschreibung

    Repeated Urine dipstick

    Alias
    UMLS CUI-1
    C0430370
    UMLS CUI-2
    C0205341
    What was the result of the urine dipstick performed at this visit?
    Beschreibung

    If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
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    Ähnliche Modelle

    GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    systolic blood pressure sitting
    Item
    Sitting systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    diastolic blood pressure sitting
    Item
    Sitting diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Item Group
    Laboratory Evaluation
    C0022877 (UMLS CUI-1)
    Date of blood sample
    Item
    Date of blood sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    laboratory label
    Item
    Please affix the Quest Diagnostics Laboratory label here.
    text
    C4273937 (UMLS CUI [1])
    Item
    Were any clinically significant abnormalities detected?
    integer
    C0005834 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    abnormalities in blood sample
    Code List
    Were any clinically significant abnormalities detected?
    CL Item
    yes (1)
    CL Item
    no (2)
    Item Group
    Urine Dipstick
    C0430370 (UMLS CUI-1)
    Item
    What was the result of the urine dipstick performed at this visit?
    integer
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Urine dipstick result
    Code List
    What was the result of the urine dipstick performed at this visit?
    CL Item
    Positive (2)
    CL Item
    Negative (1)
    Item Group
    Pregnancy dipstick
    C0430056 (UMLS CUI-1)
    Item
    Is the patient a female of child-bearing potential?
    integer
    C1960468 (UMLS CUI [1])
    female of child-bearing potential
    Code List
    Is the patient a female of child-bearing potential?
    CL Item
    no (1 )
    CL Item
    yes (2 )
    Item
    Pregnancy dipstick result
    integer
    C0430056 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Pregnancy dipstick result
    Code List
    Pregnancy dipstick result
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item Group
    Medical Procedures
    C0199171 (UMLS CUI-1)
    Item
    Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
    integer
    C0199171 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    C0430022 (UMLS CUI [3])
    C0543467 (UMLS CUI [4])
    medical procedures
    Code List
    Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
    CL Item
    No (1 )
    CL Item
    Yes (2)
    Item Group
    Medical Procedures
    C0199171 (UMLS CUI-1)
    Procedure
    Item
    Procedure
    text
    C0199171 (UMLS CUI [1])
    Indication of medical procedure
    Item
    Indication
    text
    C0199171 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Procedure Start Date
    Item
    Procedure Start Date
    date
    C0199171 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date Procedure
    Item
    End Date Procedure
    date
    C0199171 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item Group
    Prior and concomitant medication
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Item
    Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
    integer
    C2826257 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Prior and concomitant medication
    Code List
    Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
    CL Item
    no (1 )
    CL Item
    yes (2 )
    Item Group
    prior and concomitant medication
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Drug name
    Item
    Drug Name (Trade name preferred)
    text
    C0013227 (UMLS CUI [1,1])
    C0919189 (UMLS CUI [1,2])
    Total Daily Dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1])
    Diagnosis
    Item
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    text
    C0011900 (UMLS CUI [1])
    start date of medication
    Item
    Start Date (be as precise as possible)
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date of medication
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    medication is current
    Item
    Does the medication still continue?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Item Group
    Baseline signs and symptoms
    C0037088 (UMLS CUI-1)
    C1442488 (UMLS CUI-2)
    Baseline adverse reaction
    Item
    Please mark this box if no baseline events occurred prior to randomisation into study.
    boolean
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Baseline adverse reaction
    Item
    Baseline event
    text
    C0559546 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Adverse Reaction Start Date Time
    Item
    Onset Date and Time
    datetime
    C2981441 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Adverse Reaction End Date Time
    Item
    End Date and Time
    datetime
    C2981425 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Item
    Outcome
    integer
    C0559546 (UMLS CUI [1,1])
    C1624730 (UMLS CUI [1,2])
    Adverse Event Outcome
    Code List
    Outcome
    CL Item
    resolved (1)
    CL Item
    ongoing (2)
    CL Item
    died (3)
    Item
    Event Course
    integer
    C0559546 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    adverse event course
    Code List
    Event Course
    CL Item
    intermittent (1)
    CL Item
    constant (2)
    Number of episodes of adverse reaction
    Item
    Number of episodes
    integer
    C0559546 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Intensity (maximum)
    integer
    C0559546 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of the adverse event
    Code List
    Intensity (maximum)
    CL Item
    mild (1)
    CL Item
    moderate (2)
    CL Item
    severe (3)
    Item
    Relationship to study procedures performed prior to enrolment
    integer
    C0877248 (UMLS CUI [1,1])
    C1510821 (UMLS CUI [1,2])
    Relationship to study procedures
    Code List
    Relationship to study procedures performed prior to enrolment
    CL Item
    Related (5)
    CL Item
    Possibly related (6)
    CL Item
    Probably unrelated (7)
    CL Item
    Unrelated (1)
    Item
    Corrective Therapy
    integer
    C0559546 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Corrective therapy to adverse event
    Code List
    Corrective Therapy
    CL Item
    yes (1)
    CL Item
    no (2)
    Item
    Was patient withdrawn due to this specific event prior to randomisation?
    integer
    C2348568 (UMLS CUI [1,1])
    C0559546 (UMLS CUI [1,2])
    C0424092 (UMLS CUI [1,3])
    withdrawn due to this specific event prior to randomisation
    Code List
    Was patient withdrawn due to this specific event prior to randomisation?
    CL Item
    yes (1)
    CL Item
    no (2)
    Item Group
    Significant medical/surgical history and physical examination
    C0262926 (UMLS CUI-1)
    C0489540 (UMLS CUI-3)
    C0031809 (UMLS CUI-5)
    Item
    Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
    integer
    C0012634 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    Medical condition or Surgery since previous study
    Code List
    Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
    CL Item
    No (1)
    CL Item
    Yes (2)
    Item Group
    Significant medical/surgical history and physical examination
    C0262926 (UMLS CUI-1)
    C0489540 (UMLS CUI-2)
    C0031809 (UMLS CUI-3)
    Diagnosis
    Item
    text
    C0011900 (UMLS CUI [1])
    Year of diagnosis
    Item
    Year of first diagnosis (if know)
    partialDate
    C0011900 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    Item
    Past and/or ongoing (diagnosis)
    integer
    C0011900 (UMLS CUI [1,1])
    C0455458 (UMLS CUI [1,2])
    C2826680 (UMLS CUI [2])
    Past and/or ongoing medical history
    Code List
    Past and/or ongoing (diagnosis)
    CL Item
    Past (1)
    CL Item
    ongoing (2)
    CL Item
    past+ongoing (3)
    Item Group
    Patient continuation/ withdrawal
    C2348568 (UMLS CUI-1)
    Item
    Is the patient continuing in the study?
    integer
    C2348568 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Continuing study
    Code List
    Is the patient continuing in the study?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item
    Cause of withdrawal from study
    text
    C0422727 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    undefined item
    Code List
    Cause of withdrawal from study
    CL Item
    Baseline sign and symptom (please complete Baseline Signs and Symptoms page)  (1)
    CL Item
    Does not meet inclusion/exclusion criteria (10)
    CL Item
    Protocol deviation (including non-compliance) (3)
    CL Item
    Lost to follow-up (4)
    CL Item
    Other-specify: (7)
    Other cause of withdrawal from study
    Item
    Please specify 'other' cause of withdrawal from study.
    text
    C0422727 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Investigator signature
    C2346576 (UMLS CUI-1)
    Investigator signature
    Item
    Investigator signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature Date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Repeated Laboratory Evaluation
    C0022877 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Date of blood sample
    Item
    Date of blood sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory label
    Item
    Please affix the Quest Diagnostics Laboratory label here.
    text
    C4273937 (UMLS CUI [1])
    Item
    Were any clinically significant abnormalities detected?
    integer
    C0005834 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    abnormalities in blood sample
    Code List
    Were any clinically significant abnormalities detected?
    CL Item
    yes (1)
    CL Item
    no (2)
    Item Group
    Repeated Urine dipstick
    C0430370 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Item
    What was the result of the urine dipstick performed at this visit?
    integer
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Urine dipstick result
    Code List
    What was the result of the urine dipstick performed at this visit?
    CL Item
    Positive (2)
    CL Item
    Negative (1)
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