0 Bedömningar
ID

29036

Beskrivning

A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Nyckelord

Versioner (1)
  1. 21.02.18 21.02.18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21. Februar 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497

    Engelsk

    Visit 9 (Mandatory Safety Follow-Up)

    1 Formulär  
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    bpm
    Blood Pressure Systolic
    Beskrivning

    Blood Pressure Systolic

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic
    Beskrivning

    Diastolic blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Baseline Adverse Events
    Beskrivning

    Baseline Adverse Events

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
    Beskrivning

    If 'Yes', please record on the Current Medical Conditions or Adverse Events panel as appropriate. NOTE: At the Baseline Visit, only serious adverse events related to study procedures must be recorded on the Adverse Events panel. All other adverse events at the Baseline visit should be recorded on the Current Medical Conditions panel.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Concomitant Medication Prompt
    Beskrivning

    Concomitant Medication Prompt

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Were there any changes in concomitant medication since the last visit?
    Beskrivning

    If 'Yes', please record on the Prior and Concomitant Medications panel. Saving this panel after selecting 'Yes' will take you to the Prior and Concomitant Medications panel located in the Additional Forms section of the eCRF.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2169461 (recent change in medication)
    Repeat 12-lead electrocardiogram prompt
    Beskrivning

    Repeat 12-lead electrocardiogram prompt

    Alias
    UMLS CUI-1
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    UMLS CUI-2
    C0205341 (Repeat)
    SNOMED
    27582007
    Was a repeat 12-Lead Electrocardiogram performed at this visit ?
    Beskrivning

    If 'Yes', please record on the Repeat 12-Lead Electrocardiogram panel.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    UMLS CUI [1,2]
    C0205341 (Repeat)
    SNOMED
    27582007
    Repeat Laboratory tests
    Beskrivning

    Repeat Laboratory tests

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C0205341 (Repeat)
    SNOMED
    27582007
    Were repeat laboratory tests performed at this visit ?
    Beskrivning

    If 'Yes', please record on the Repeat Laboratory Tests panel.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [1,2]
    C0205341 (Repeat)
    SNOMED
    27582007
    Investigational Product Prompt
    Beskrivning

    Investigational Product Prompt

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    Details of the Investigational Product dispensed at the previous visit need to be entered into the eCRF at this visit. Do you have the details available to enter the data?
    Beskrivning

    If 'Yes', please record on the Investigational Product panel.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0304229 (Experimental drug)
    Urine dipstick pregnancy test
    Beskrivning

    Urine dipstick pregnancy test

    Alias
    UMLS CUI-1
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    Was a urine dipstick performed?
    Beskrivning

    If "Yes", please record result below.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    Sample Date
    Beskrivning

    Urine dipstick pregnancy sample date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    UMLS CUI [1,2]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Result
    Beskrivning

    If "Positive", withdraw the subject and complete the paper Pregnancy Notification form. Also complete the Early Withdrawal Visit and the End of Study Record panels.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0430056 (Urine pregnancy test)
    SNOMED
    167252002
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    Comments
    Beskrivning

    Comments

    Alias
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI-2
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Comments
    Beskrivning

    Research Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Tillbaka till toppen

    Similar models

    Visit 9 (Mandatory Safety Follow-Up)

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C0518766 (UMLS CUI-1)
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Item Group
    Baseline Adverse Events
    C0877248 (UMLS CUI-1)
    adverse events
    Item
    Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Concomitant Medication Prompt
    C2347852 (UMLS CUI-1)
    concomitant medication changes
    Item
    Were there any changes in concomitant medication since the last visit?
    boolean
    C2347852 (UMLS CUI [1,1])
    C2169461 (UMLS CUI [1,2])
    Item Group
    C0013798 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Repeated 12-lead EKG
    Item
    Was a repeat 12-Lead Electrocardiogram performed at this visit ?
    boolean
    C0013798 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    Item Group
    C0022885 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Repeat Laboratory tests
    Item
    Were repeat laboratory tests performed at this visit ?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    Item Group
    Investigational Product Prompt
    C0304229 (UMLS CUI-1)
    Investigational Product
    Item
    Details of the Investigational Product dispensed at the previous visit need to be entered into the eCRF at this visit. Do you have the details available to enter the data?
    boolean
    C0304229 (UMLS CUI [1])
    Item Group
    Urine dipstick pregnancy test
    C0430056 (UMLS CUI-1)
    Urine dipstick pregnancy test
    Item
    Was a urine dipstick performed?
    boolean
    C0430056 (UMLS CUI [1])
    Urine dipstick pregnancy sample date
    Item
    Sample Date
    date
    C0430056 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Urine dipstick pregnancy result
    Item
    Result
    boolean
    C0430056 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Research Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial