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Informações:
Falhas:
ID
33271
Descrição
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 informations about any dermatological or hypersensitivity adverse event form. It should be filled out when any of those occurr during the study. 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
Palavras-chave
Versões (4)
- 03/12/2018 03/12/2018 -
- 25/12/2018 25/12/2018 -
- 10/01/2019 10/01/2019 - Sarah Riepenhausen
- 20/09/2021 20/09/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
3 de dezembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
Dermatological/Hypersensitivity Adverse Event Form
- StudyEvent: ODM
Similar models
Dermatological/Hypersensitivity Adverse Event Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Hypersensitivity Adverse Event Form Completed
Item
Has a Dermatological/Hypersensitivity Adverse Event Form been completed?
boolean
C0205489 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3482224 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C3482224 (UMLS CUI [1,3])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])
Item Group
Record of Concomitant Medications
C0877248 (UMLS CUI-1)
C0037274 (UMLS CUI-2)
C0877248 (UMLS CUI-4)
C0020517 (UMLS CUI-5)
C0037274 (UMLS CUI-2)
C0877248 (UMLS CUI-4)
C0020517 (UMLS CUI-5)
Adverse Event evaluated by Dermatologist
Item
Was the dermatological adverse event evaluated by a dermatologist?
boolean
C0877248 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0259831 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,2])
C0259831 (UMLS CUI [1,3])
Onset Date of Reaction
Item
Onset Date of Reaction
date
C0574845 (UMLS CUI [1])
Systemic Symptoms, Signs or Laboratory Abnormalities
Item
Were other systemic symptoms, signs or laboratory abnormalities seen?
integer
C1853129 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0037088 (UMLS CUI [2])
Item Group
Systemic Symptoms, Signs or Laboratory Abnormalities
C1853129 (UMLS CUI-1)
C0037088 (UMLS CUI-3)
C0037088 (UMLS CUI-3)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Pharyngitis
Item
Pharyngitis
boolean
C0031350 (UMLS CUI [1])
Rhabdomyolysis
Item
Rhabdomyolysis
boolean
C0035410 (UMLS CUI [1])
Lymphadenopathie
Item
Lymphadenopathie
boolean
C0497156 (UMLS CUI [1])
Facial Swelling
Item
Facial Swelling
boolean
C0038999 (UMLS CUI [1,1])
C0015450 (UMLS CUI [1,2])
C0015450 (UMLS CUI [1,2])
Hepatic Abnormalities
Item
Hepatic Abnormalities
boolean
C4021780 (UMLS CUI [1])
Pulmonary Abnormalities
Item
Pulmonary Abnormalities
boolean
C2709248 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Haematological Abnormalities
Item
Haematological Abnormalities
boolean
C1853129 (UMLS CUI [1,1])
C0279810 (UMLS CUI [1,2])
C0279810 (UMLS CUI [1,2])
Cardiac Abnormalities
Item
Cardiac Abnormalities
boolean
C0018799 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,2])
Renal Abnormalities
Item
Renal Abnormalities
text
C1704258 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,2])
Conjunctival Abnormalities
Item
Conjunctival Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0009758 (UMLS CUI [1,2])
C0009758 (UMLS CUI [1,2])
Oral Mucosal Abnormalities
Item
Oral Mucosal Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0026639 (UMLS CUI [1,2])
C0026639 (UMLS CUI [1,2])
Other Mucosal Abnormalities
Item
Other Mucosal Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0026724 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Skin Pain
Item
Skin Pain
boolean
C0030193 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,2])
Other
Item
Other
text
C0205394 (UMLS CUI [1])
Item Group
Haematologic Abnormalities
C0279810 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Eosinophilia
Item
Eosinophilia
boolean
C2240374 (UMLS CUI [1])
Atypical Lymphocytes
Item
Atypical Lymphocytes
boolean
C0221277 (UMLS CUI [1])
Thrombocytopenia
Item
Thrombocytopenia
boolean
C0040034 (UMLS CUI [1])
Leucopenia
Item
Leucopenia
boolean
C0023530 (UMLS CUI [1])
Anemia
Item
Anemia
boolean
C0002871 (UMLS CUI [1])
Neutrophilia
Item
Neutrophilia
boolean
C0151683 (UMLS CUI [1])
Leukocytosis
Item
Leukocytosis
boolean
C0023518 (UMLS CUI [1])
Item Group
Supportive/Investigative Measures
C0079809 (UMLS CUI-1)
Drug Discontinued
Item
Drug Discontinued
boolean
C0558681 (UMLS CUI [1])
IV Steroids
Item
IV Steroids
boolean
C0038317 (UMLS CUI [1,1])
C0348016 (UMLS CUI [1,2])
C0348016 (UMLS CUI [1,2])
Oral Steroids
Item
Oral Steroids
boolean
C0038317 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,2])
Topical Steroids
Item
Topical Steroids
boolean
C2064827 (UMLS CUI [1])
Hospitalisation Due to Rash
Item
Hospitalisation Due to Rash
boolean
C0019993 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0015230 (UMLS CUI [1,2])
Antihistamines
Item
Antihistamines
boolean
C0003360 (UMLS CUI [1])
Skin Biopsy
Item
Skin Biopsy
boolean
C0150866 (UMLS CUI [1])
Photographs
Item
Photographs
boolean
C0441468 (UMLS CUI [1])
Unknown
Item
Unknown
boolean
C0439673 (UMLS CUI [1])
Other
Item
Other
text
C0205394 (UMLS CUI [1])
Urticaria
Item
Urticaria
boolean
C0042109 (UMLS CUI [1])
Angioedema
Item
Angioedema
boolean
C0002994 (UMLS CUI [1])
Stevens-Johnson Syndrome
Item
Stevens-Johnson Syndrome
boolean
C0038325 (UMLS CUI [1])
Toxic Epidermal Necrolysis
Item
Toxic Epidermal Necrolysis
boolean
C0014518 (UMLS CUI [1])
Erythema Multiforme Major
Item
Erythema Multiforme Major
boolean
C0014742 (UMLS CUI [1])
Photosensitivity
Item
Photosensitivity
boolean
C0349506 (UMLS CUI [1])
Hypersensitivity
Item
Hypersensitivity
boolean
C0020517 (UMLS CUI [1])
Morbilliform Rash
Item
Morbilliform Rash
boolean
C0234918 (UMLS CUI [1])
Unknown
Item
Unknown
boolean
C0439673 (UMLS CUI [1])
Other
Item
Other
text
C0205394 (UMLS CUI [1])
CL Item
Investigator (1)
CL Item
Dermatologist (2)
Item Group
Responsible for Diagnosis
C0680379 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0011900 (UMLS CUI-2)
Item
Who made the diagnosis?
integer
C0680379 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Investigator (1)
CL Item
Dermatologist (2)
Face
Item
Face
boolean
C0015450 (UMLS CUI [1])
Neck
Item
Neck
boolean
C0027530 (UMLS CUI [1])
Trunk
Item
Trunk
boolean
C0460005 (UMLS CUI [1])
Upper Extremities
Item
Upper Extremities
boolean
C0015385 (UMLS CUI [1])
Lower Extremities
Item
Lower Extremities
boolean
C0023216 (UMLS CUI [1])
Other
Item
Other
text
C0205394 (UMLS CUI [1])
Item
Was the subject taking any other medication at the time of this dermatological adverse event?
text
C2347852 (UMLS CUI [1])
Code List
Was the subject taking any other medication at the time of this dermatological adverse event?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Item
Did this drug contribute to the dermatological drug reaction?
text
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0013182 (UMLS CUI [1,3])
C1880177 (UMLS CUI [1,2])
C0013182 (UMLS CUI [1,3])
Code List
Did this drug contribute to the dermatological drug reaction?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])