ID
38048
Beschrijving
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
Trefwoorden
Versies (2)
- 12-09-19 12-09-19 -
- 12-09-19 12-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 september 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123)
Visit 1 / Screen - Present Medication; Vital Signs; Physical Examination
Beschrijving
Present Medication - Present chronic AED Therapy
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0150312
- UMLS CUI-3
- C0003299
- UMLS CUI-4
- C0205191
Beschrijving
Present chronic AED Therapy - Drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0150312
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [1,3]
- C0205191
- UMLS CUI [2]
- C0013227
Beschrijving
Present Chronic AED Therapy - Total Daily Dose
Datatype
float
Maateenheden
- 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
Beschrijving
Present chronic AED Therapy - Date present dose started
Datatype
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
Beschrijving
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
Beschrijving
Emergency AED Therapy used irregularly as required - Drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013956
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [2]
- C0013227
Beschrijving
Emergency AED Therapy used irregularly as required - Total Daily Dose
Datatype
float
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C0013956
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [2,1]
- C2348070
- UMLS CUI [2,2]
- C0439810
Beschrijving
Emergency AED Therapy used irregularly as required - Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013956
- UMLS CUI [1,2]
- C0003299
- UMLS CUI [2]
- C0013153
Beschrijving
Present Medication - Other Medication
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0150312
- UMLS CUI-3
- C0205394
Beschrijving
Other Medication - Drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C0205394
Beschrijving
Other Medication - Total Daily Dose
Datatype
float
Maateenheden
- 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
Beschrijving
Other Medication - Date present dose started
Datatype
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
Beschrijving
Other Medication - Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C3146298
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Systolic blood pressure sitting
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschrijving
Diastolic blood pressure sitting
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschrijving
Pulse sitting
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C2029904
Beschrijving
Weight
Datatype
integer
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Eyes
Datatype
integer
Alias
- UMLS CUI [1]
- C0015392
Beschrijving
Ears, Nose, Throat
Datatype
integer
Alias
- UMLS CUI [1]
- C0278350
Beschrijving
Cardiovascular
Datatype
integer
Alias
- UMLS CUI [1]
- C0007226
Beschrijving
Pulmonary
Datatype
integer
Alias
- UMLS CUI [1]
- C2709248
Beschrijving
Abdomen
Datatype
integer
Alias
- UMLS CUI [1]
- C0000726
Beschrijving
Please give brief details.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C0000726
Beschrijving
Please give brief details.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C0015392
Beschrijving
Please give brief details.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C0278350
Beschrijving
Please give brief details.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C0007226
Beschrijving
Please give brief details.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C2709248
Beschrijving
Lymph nodes
Datatype
integer
Alias
- UMLS CUI [1]
- C0024204
Beschrijving
Please give brief details.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C0024204
Beschrijving
Extremities
Datatype
integer
Alias
- UMLS CUI [1]
- C0436150
Beschrijving
Please give brief details.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C0436150
Beschrijving
Please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other examination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other examination - Abnormal physical finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826636
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0205394
Similar models
Visit 1 / Screen - Present Medication; Vital Signs; Physical Examination
C0600091 (UMLS CUI [1,2])
C0150312 (UMLS CUI-2)
C0003299 (UMLS CUI-3)
C0205191 (UMLS CUI-4)
C0003299 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
C0003299 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
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])
C0150312 (UMLS CUI-2)
C0013956 (UMLS CUI-3)
C0003299 (UMLS CUI-4)
C0003299 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2])
C0003299 (UMLS CUI [1,2])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C0003299 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2])
C0150312 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0150312 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
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])
C0150312 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
C0007226 (UMLS CUI [1,2])
C2709248 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
C0436150 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])