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ID

38049

Beschreibung

Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

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Versionen (2)
  1. 12.09.19 12.09.19 -
  2. 12.09.19 12.09.19 -
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GlaxoSmithKline

Hochgeladen am

12. September 2019

DOI

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Creative Commons BY-NC 3.0
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    Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)

    Englisch

    Visit 1 / Screen - Present Medication; Vital Signs; Physical Examination

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient's initials
    Beschreibung

    Patient's initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient's trial number
    Beschreibung

    Patient's trial number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Center number
    Beschreibung

    Center number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Present Medication - Present chronic AED Therapy
    Beschreibung

    Present Medication - Present chronic AED Therapy

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0150312
    UMLS CUI-3
    C0003299
    UMLS CUI-4
    C0205191
    Present chronic AED Therapy - Drug
    Beschreibung

    Present chronic AED Therapy - Drug

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0150312
    UMLS CUI [1,2]
    C0003299
    UMLS CUI [1,3]
    C0205191
    UMLS CUI [2]
    C0013227
    Present Chronic AED Therapy - Total Daily Dose
    Beschreibung

    Present Chronic AED Therapy - Total Daily Dose

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0150312
    UMLS CUI [1,2]
    C0003299
    UMLS CUI [1,3]
    C0205191
    UMLS CUI [2,1]
    C2348070
    UMLS CUI [2,2]
    C0439810
    mg
    Present chronic AED Therapy - Date present dose started
    Beschreibung

    Present chronic AED Therapy - Date present dose started

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0150312
    UMLS CUI [1,2]
    C0003299
    UMLS CUI [1,3]
    C0205191
    UMLS CUI [2,1]
    C0808070
    UMLS CUI [2,2]
    C3174092
    UMLS CUI [2,3]
    C0150312
    Present Medication - Emergency AED Therapy used irregularly as required
    Beschreibung

    Present Medication - Emergency AED Therapy used irregularly as required

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0150312
    UMLS CUI-3
    C0013956
    UMLS CUI-4
    C0003299
    Emergency AED Therapy used irregularly as required - Drug
    Beschreibung

    Emergency AED Therapy used irregularly as required - Drug

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013956
    UMLS CUI [1,2]
    C0003299
    UMLS CUI [2]
    C0013227
    Emergency AED Therapy used irregularly as required - Total Daily Dose
    Beschreibung

    Emergency AED Therapy used irregularly as required - Total Daily Dose

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0013956
    UMLS CUI [1,2]
    C0003299
    UMLS CUI [2,1]
    C2348070
    UMLS CUI [2,2]
    C0439810
    mg
    Emergency AED Therapy used irregularly as required - Route
    Beschreibung

    Emergency AED Therapy used irregularly as required - Route

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013956
    UMLS CUI [1,2]
    C0003299
    UMLS CUI [2]
    C0013153
    Present Medication - Other Medication
    Beschreibung

    Present Medication - Other Medication

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0150312
    UMLS CUI-3
    C0205394
    Other Medication - Drug
    Beschreibung

    Other Medication - Drug

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [1,3]
    C0205394
    Other Medication - Total Daily Dose
    Beschreibung

    Other Medication - Total Daily Dose

    Datentyp

    float

    Maßeinheiten
    • mg
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2,1]
    C2348070
    UMLS CUI [2,2]
    C0439810
    mg
    Other Medication - Date present dose started
    Beschreibung

    Other Medication - Date present dose started

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2,1]
    C0808070
    UMLS CUI [2,2]
    C3174092
    UMLS CUI [2,3]
    C0150312
    Other Medication - Indication
    Beschreibung

    Other Medication - Indication

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0150312
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2]
    C3146298
    Vital Signs
    Beschreibung

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Systolic blood pressure sitting
    Beschreibung

    Systolic blood pressure sitting

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mm[Hg]
    Diastolic blood pressure sitting
    Beschreibung

    Diastolic blood pressure sitting

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mm[Hg]
    Pulse sitting
    Beschreibung

    Pulse sitting

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C2029904
    beats/min
    Weight
    Beschreibung

    Weight

    Datentyp

    integer

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Height
    Beschreibung

    Height

    Datentyp

    integer

    Maßeinheiten
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Physical Examination
    Beschreibung

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Eyes
    Beschreibung

    Eyes

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0015392
    Eyes - Abnormal physical finding
    Beschreibung

    Please give brief details.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C0015392
    Ears, Nose, Throat
    Beschreibung

    Ears, Nose, Throat

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0278350
    Ears, Nose, Throat - Abnormal physical finding
    Beschreibung

    Please give brief details.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C0278350
    Cardiovascular
    Beschreibung

    Cardiovascular

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0007226
    Cardiovascular - Abnormal physical finding
    Beschreibung

    Please give brief details.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C0007226
    Pulmonary
    Beschreibung

    Pulmonary

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2709248
    Pulmonary - Abnormal physical finding
    Beschreibung

    Please give brief details.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C2709248
    Abdomen
    Beschreibung

    Abdomen

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0000726
    Abdomen - Abnormal physical finding
    Beschreibung

    Please give brief details.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C0000726
    Lymph nodes
    Beschreibung

    Lymph nodes

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0024204
    Lymph nodes - Abnormal physical finding
    Beschreibung

    Please give brief details.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C0024204
    Extremities
    Beschreibung

    Extremities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0436150
    Extremities - Abnormal physical finding
    Beschreibung

    Please give brief details.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C0436150
    Other examination
    Beschreibung

    Please specify.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    Other examination
    Beschreibung

    Other examination

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    Other examination - Abnormal physical finding
    Beschreibung

    Other examination - Abnormal physical finding

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2826636
    UMLS CUI [1,2]
    C0031809
    UMLS CUI [1,3]
    C0205394
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Visit 1 / Screen - Present Medication; Vital Signs; Physical Examination

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient's initials
    Item
    Patient's initials
    text
    C2986440 (UMLS CUI [1])
    Patient's trial number
    Item
    Patient's trial number
    text
    C2348585 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    Present Medication - Present chronic AED Therapy
    C0013227 (UMLS CUI-1)
    C0150312 (UMLS CUI-2)
    C0003299 (UMLS CUI-3)
    C0205191 (UMLS CUI-4)
    Item
    Present chronic AED Therapy - Drug
    text
    C0150312 (UMLS CUI [1,1])
    C0003299 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2])
    Drug
    Code List
    Present chronic AED Therapy - Drug
    CL Item
    Acetazoiamide  (ACE)
    CL Item
    Carbamazepine  (CBZ)
    CL Item
    Carbamazepine Retard (CBZR)
    CL Item
    Clobazam  (CLB)
    CL Item
    Clonazepam  (CZP)
    CL Item
    Diazepam  (DZP)
    CL Item
    Ethosuximide  (ESM)
    CL Item
    Flunarizine  (FNR)
    CL Item
    Hydrocortisone  (HC)
    CL Item
    Lamotrigine (LTG)
    CL Item
    Lorazepam  (LZP)
    CL Item
    Nitrazepam  (NZP)
    CL Item
    Oxcarbazepine  (OCZ)
    CL Item
    Phenobarbitone  (PB)
    CL Item
    Phenytoin  (PHT)
    CL Item
    Primidone  (PRM)
    CL Item
    Sulthiame  (SUL)
    CL Item
    Valproate Sodium  (VPA)
    CL Item
    Vigabatrin (VGB)
    Present Chronic AED Therapy - Total Daily Dose
    Item
    Present Chronic AED Therapy - Total Daily Dose
    float
    C0150312 (UMLS CUI [1,1])
    C0003299 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    C2348070 (UMLS CUI [2,1])
    C0439810 (UMLS CUI [2,2])
    Present chronic AED Therapy - Date present dose started
    Item
    Present chronic AED Therapy - Date present dose started
    date
    C0150312 (UMLS CUI [1,1])
    C0003299 (UMLS CUI [1,2])
    C0205191 (UMLS CUI [1,3])
    C0808070 (UMLS CUI [2,1])
    C3174092 (UMLS CUI [2,2])
    C0150312 (UMLS CUI [2,3])
    Item Group
    Present Medication - Emergency AED Therapy used irregularly as required
    C0013227 (UMLS CUI-1)
    C0150312 (UMLS CUI-2)
    C0013956 (UMLS CUI-3)
    C0003299 (UMLS CUI-4)
    Item
    Emergency AED Therapy used irregularly as required - Drug
    text
    C0013956 (UMLS CUI [1,1])
    C0003299 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2])
    Emergency AED Therapy used irregularly as required - Drug
    Code List
    Emergency AED Therapy used irregularly as required - Drug
    CL Item
    Acetazoiamide  (ACE)
    CL Item
    Carbamazepine  (CBZ)
    CL Item
    Carbamazepine Retard (CBZR)
    CL Item
    Clobazam  (CLB)
    CL Item
    Clonazepam  (CZP)
    CL Item
    Diazepam  (DZP)
    CL Item
    Ethosuximide  (ESM)
    CL Item
    Flunarizine  (FNR)
    CL Item
    Hydrocortisone  (HC)
    CL Item
    Lamotrigine (LTG)
    CL Item
    Lorazepam  (LZP)
    CL Item
    Nitrazepam  (NZP)
    CL Item
    Oxcarbazepine  (OCZ)
    CL Item
    Phenobarbitone  (PB)
    CL Item
    Phenytoin  (PHT)
    CL Item
    Primidone  (PRM)
    CL Item
    Sulthiame  (SUL)
    CL Item
    Valproate Sodium  (VPA)
    CL Item
    Vigabatrin (VGB)
    Emergency AED Therapy used irregularly as required - Total Daily Dose
    Item
    Emergency AED Therapy used irregularly as required - Total Daily Dose
    float
    C0013956 (UMLS CUI [1,1])
    C0003299 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [2,1])
    C0439810 (UMLS CUI [2,2])
    Item
    Emergency AED Therapy used irregularly as required - Route
    text
    C0013956 (UMLS CUI [1,1])
    C0003299 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [2])
    Emergency AED Therapy used irregularly as required - Route
    Code List
    Emergency AED Therapy used irregularly as required - Route
    CL Item
    By mouth (PO)
    CL Item
    By rectum (PR)
    CL Item
    Intravenous (IV)
    CL Item
    Intramuscular (IM)
    CL Item
    Infusion (INF)
    Item Group
    Present Medication - Other Medication
    C0013227 (UMLS CUI-1)
    C0150312 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Other Medication - Drug
    Item
    Other Medication - Drug
    text
    C0013227 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Other Medication - Total Daily Dose
    Item
    Other Medication - Total Daily Dose
    float
    C0013227 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348070 (UMLS CUI [2,1])
    C0439810 (UMLS CUI [2,2])
    Other Medication - Date present dose started
    Item
    Other Medication - Date present dose started
    date
    C0013227 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0808070 (UMLS CUI [2,1])
    C3174092 (UMLS CUI [2,2])
    C0150312 (UMLS CUI [2,3])
    Other Medication - Indication
    Item
    Other Medication - Indication
    text
    C0013227 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C3146298 (UMLS CUI [2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic blood pressure sitting
    Item
    Systolic blood pressure sitting
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Diastolic blood pressure sitting
    Item
    Diastolic blood pressure sitting
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Pulse sitting
    Item
    Pulse sitting
    integer
    C2029904 (UMLS CUI [1])
    Weight
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Eyes
    integer
    C0015392 (UMLS CUI [1])
    Eyes
    Code List
    Eyes
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examined (3)
    Eyes - Abnormal physical finding
    Item
    Eyes - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C0015392 (UMLS CUI [1,2])
    Item
    Ears, Nose, Throat
    integer
    C0278350 (UMLS CUI [1])
    Ears, Nose, Throat
    Code List
    Ears, Nose, Throat
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examined (3)
    Ears, Nose, Throat - Abnormal physical finding
    Item
    Ears, Nose, Throat - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C0278350 (UMLS CUI [1,2])
    Item
    Cardiovascular
    integer
    C0007226 (UMLS CUI [1])
    Cardiovascular
    Code List
    Cardiovascular
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examined (3)
    Cardiovascular - Abnormal physical finding
    Item
    Cardiovascular - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C0007226 (UMLS CUI [1,2])
    Item
    Pulmonary
    integer
    C2709248 (UMLS CUI [1])
    Pulmonary
    Code List
    Pulmonary
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examined (3)
    Pulmonary - Abnormal physical finding
    Item
    Pulmonary - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C2709248 (UMLS CUI [1,2])
    Item
    Abdomen
    integer
    C0000726 (UMLS CUI [1])
    Abdomen
    Code List
    Abdomen
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examined (3)
    Abdomen - Abnormal physical finding
    Item
    Abdomen - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Item
    Lymph nodes
    integer
    C0024204 (UMLS CUI [1])
    Lymph nodes
    Code List
    Lymph nodes
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examined (3)
    Lymph nodes - Abnormal physical finding
    Item
    Lymph nodes - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C0024204 (UMLS CUI [1,2])
    Item
    Extremities
    integer
    C0436150 (UMLS CUI [1])
    Extremities
    Code List
    Extremities
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not examined (3)
    Extremities - Abnormal physical finding
    Item
    Extremities - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C0436150 (UMLS CUI [1,2])
    Other examination
    Item
    Other examination
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    Other examination
    integer
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other examination
    Code List
    Other examination
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Other examination - Abnormal physical finding
    Item
    Other examination - Abnormal physical finding
    text
    C2826636 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
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