0 Evaluaciones
ID

33622

Descripción

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about the subjects history of dermatological drug reactions. It should be filled out at each treatment period visit. Complete the Dermatological Drug Reaction History pages for each drug reaction experienced. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Palabras clave

Versiones (2)
  1. 3/12/18 3/12/18 -
  2. 16/12/18 16/12/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de diciembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Effect of Lamictal on Resting Motor Threshold Study-ID 107434

    Inglés

    Dermatological Drug Reaction History

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Screening number
    Descripción

    Subject Screening No.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0220908
    UMLS CUI [1,2]
    C0600091
    Subject no.
    Descripción

    Subject Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of Assessment
    Descripción

    Date of Assessment

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Study Visit
    Descripción

    Study Visit

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0545082
    Dermatological Drug Reaction History
    Descripción

    Dermatological Drug Reaction History

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0037274
    UMLS CUI-3
    C0041755
    Has the subject experienced any type of physician diagnosed dermatologic reaction to any drug?
    Descripción

    If Yes, complete the following items.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0037274
    UMLS CUI [1,3]
    C0013182
    Name of suspect drug implicated (trade name preferred)
    Descripción

    Drug Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065
    Onset Date of Reaction
    Descripción

    Onset Date of Reaction

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C1527304
    During what time period after initiation of the drug did the rash occur?
    Descripción

    Tick one box only

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2745955
    UMLS CUI [1,3]
    C0011008
    Was the reaction considered severe?
    Descripción

    Severe Reaction

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0205082
    Was the subject hospitlaised due to the reaction?
    Descripción

    Hospitalisation

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0019993
    Was the drug discontinued?
    Descripción

    If Yes, did the reaction resolve when the drug was discontinued?

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0558681
    Did the drug reaction resolve after drug disconitnuation?
    Descripción

    Drug Reaction Resolved

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0558681
    UMLS CUI [1,2]
    C1527304
    UMLS CUI [1,3]
    C3714811
    Did the reaction reappear with rechallenge?
    Descripción

    Reaction Reappearance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0277556
    Were other systemic symptoms seen?
    Descripción

    If Yes, tick all that apply

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2039684
    UMLS CUI [1,2]
    C0205394
    Fever
    Descripción

    Fever

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    Pharyngitis
    Descripción

    Pharyngitis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0031350
    Rhabdomyolysis
    Descripción

    Rhabdomyolysis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0035410
    Lymphadenopathy
    Descripción

    Lymphadenopathy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0497156
    Facial Swelling
    Descripción

    Facial Swelling

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0038999
    UMLS CUI [1,2]
    C0015450
    Hepatic abnormalities
    Descripción

    Hepatic abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    Pulmonar abnormalities
    Descripción

    Pulmonar abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0035237
    Hematologic Abnormalities
    Descripción

    Hematologic Abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0850715
    Cardiac Abnormalities
    Descripción

    Cardiac Abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018787
    UMLS CUI [1,2]
    C1704258
    Renal Abnormalities
    Descripción

    Renal Abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0022646
    UMLS CUI [1,2]
    C1704258
    Conjunctival Lesions
    Descripción

    Conjunctival Lesions

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0009758
    Oral Mucosal Abnormalities
    Descripción

    Oral Mucosal Abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0442027
    UMLS CUI [1,2]
    C0026724
    UMLS CUI [1,3]
    C1704258
    Other Mucosal Abnormalities
    Descripción

    Other Mucosal Abnormalities

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0026724
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    Skin Pain
    Descripción

    Skin Pain

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1123023
    UMLS CUI [1,2]
    C0030193
    Other Symptom
    Descripción

    Other Symptom

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205394
    Physician's Diagnosis
    Descripción

    Physician's Diagnosis

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0031831
    Other, specify
    Descripción

    Other

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0205394
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    Similar models

    Dermatological Drug Reaction History

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Screening No.
    Item
    Subject Screening number
    integer
    C0220908 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject Number
    Item
    Subject no.
    integer
    C2348585 (UMLS CUI [1])
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Study Visit
    text
    C0545082 (UMLS CUI [1])
    Study Visit
    Code List
    Study Visit
    CL Item
    Treatment Period 1 (Treatment Period 1)
    CL Item
    Treatment Period 2 (Treatment Period 2)
    CL Item
    Treatment Period 3 (Treatment Period 3)
    Item Group
    Dermatological Drug Reaction History
    C0262926 (UMLS CUI-1)
    C0037274 (UMLS CUI-2)
    C0041755 (UMLS CUI-3)
    Item
    Has the subject experienced any type of physician diagnosed dermatologic reaction to any drug?
    text
    C0262926 (UMLS CUI [1,1])
    C0037274 (UMLS CUI [1,2])
    C0013182 (UMLS CUI [1,3])
    History of Dermatologic Drug Reaction
    Code List
    Has the subject experienced any type of physician diagnosed dermatologic reaction to any drug?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Drug Name
    Item
    Name of suspect drug implicated (trade name preferred)
    text
    C2360065 (UMLS CUI [1])
    Onset Date of Reaction
    Item
    Onset Date of Reaction
    date
    C0574845 (UMLS CUI [1,1])
    C1527304 (UMLS CUI [1,2])
    Item
    During what time period after initiation of the drug did the rash occur?
    integer
    C0877248 (UMLS CUI [1,1])
    C2745955 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Time Period of Rash Occurance
    Code List
    During what time period after initiation of the drug did the rash occur?
    CL Item
    Within first 6 weeks (1)
    CL Item
    After the first 6 weeks (2)
    Item
    Was the reaction considered severe?
    text
    C1527304 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Severe Reaction
    Code List
    Was the reaction considered severe?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Item
    Was the subject hospitlaised due to the reaction?
    text
    C0019993 (UMLS CUI [1])
    Hospitalisation
    Code List
    Was the subject hospitlaised due to the reaction?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Item
    Was the drug discontinued?
    text
    C0558681 (UMLS CUI [1])
    Drug Discontinuation
    Code List
    Was the drug discontinued?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Item
    Did the drug reaction resolve after drug disconitnuation?
    text
    C0558681 (UMLS CUI [1,1])
    C1527304 (UMLS CUI [1,2])
    C3714811 (UMLS CUI [1,3])
    Drug Reaction Resolved
    Code List
    Did the drug reaction resolve after drug disconitnuation?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Item
    Did the reaction reappear with rechallenge?
    text
    C0877248 (UMLS CUI [1,1])
    C0277556 (UMLS CUI [1,2])
    Reaction Reappearance
    Code List
    Did the reaction reappear with rechallenge?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Item
    Were other systemic symptoms seen?
    text
    C2039684 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other Systemic Symptoms
    Code List
    Were other systemic symptoms seen?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Unknown (Unknown)
    Fever
    Item
    Fever
    boolean
    C0015967 (UMLS CUI [1])
    Pharyngitis
    Item
    Pharyngitis
    boolean
    C0031350 (UMLS CUI [1])
    Rhabdomyolysis
    Item
    Rhabdomyolysis
    boolean
    C0035410 (UMLS CUI [1])
    Lymphadenopathy
    Item
    Lymphadenopathy
    boolean
    C0497156 (UMLS CUI [1])
    Facial Swelling
    Item
    Facial Swelling
    boolean
    C0038999 (UMLS CUI [1,1])
    C0015450 (UMLS CUI [1,2])
    Hepatic abnormalities
    Item
    Hepatic abnormalities
    boolean
    C0023895 (UMLS CUI [1])
    Pulmonar abnormalities
    Item
    Pulmonar abnormalities
    boolean
    C1704258 (UMLS CUI [1,1])
    C0035237 (UMLS CUI [1,2])
    Hematologic Abnormalities
    Item
    Hematologic Abnormalities
    boolean
    C0850715 (UMLS CUI [1])
    Cardiac Abnormalities
    Item
    Cardiac Abnormalities
    boolean
    C0018787 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Renal Abnormalities
    Item
    Renal Abnormalities
    boolean
    C0022646 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Conjunctival Lesions
    Item
    Conjunctival Lesions
    boolean
    C0221198 (UMLS CUI [1,1])
    C0009758 (UMLS CUI [1,2])
    Oral Mucosal Abnormalities
    Item
    Oral Mucosal Abnormalities
    boolean
    C0442027 (UMLS CUI [1,1])
    C0026724 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    Other Mucosal Abnormalities
    Item
    Other Mucosal Abnormalities
    boolean
    C0026724 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Skin Pain
    Item
    Skin Pain
    boolean
    C1123023 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    Other Symptom
    Item
    Other Symptom
    boolean
    C0037088 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    Physician's Diagnosis
    integer
    C0011900 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Physician's Diagnosis
    Code List
    Physician's Diagnosis
    CL Item
    Urticaria (1)
    CL Item
    Anigoedema (2)
    CL Item
    Stevens-Johnson-Syndrome (3)
    CL Item
    Toxic Epidermal Necrolysis (4)
    CL Item
    Erythema Multiforme Major (5)
    CL Item
    Photosensitivity (6)
    CL Item
    Hypersensitivity (7)
    CL Item
    Morbiliform Rash (8)
    CL Item
    Unknown (9)
    CL Item
    Other, Specify (10)
    Other
    Item
    Other, specify
    text
    C0205394 (UMLS CUI [1])
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