ID

33271

Beskrivning

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

Nyckelord

Versioner (4)
  1. 2018-12-03 2018-12-03 -
  2. 2018-12-25 2018-12-25 -
  3. 2019-01-10 2019-01-10 - Sarah Riepenhausen
  4. 2021-09-20 2021-09-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 december 2018

DOI

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

Engelsk

Dermatological/Hypersensitivity Adverse Event Form

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beskrivning

Subject Screening No.

Datatyp

integer

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

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Has a Dermatological/Hypersensitivity Adverse Event Form been completed?
Beskrivning

Hypersensitivity Adverse Event Form Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205489
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3482224
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Record of Concomitant Medications
Beskrivning

Record of Concomitant Medications

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0037274
UMLS CUI-4
C0877248
UMLS CUI-5
C0020517
Was the dermatological adverse event evaluated by a dermatologist?
Beskrivning

Adverse Event evaluated by Dermatologist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0259831
Onset Date of Reaction
Beskrivning

Onset Date of Reaction

Datatyp

date

Alias
UMLS CUI [1]
C0574845
Were other systemic symptoms, signs or laboratory abnormalities seen?
Beskrivning

If Yes, tick all that apply

Datatyp

integer

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0037088
Systemic Symptoms, Signs or Laboratory Abnormalities
Beskrivning

Systemic Symptoms, Signs or Laboratory Abnormalities

Alias
UMLS CUI-1
C1853129
UMLS CUI-3
C0037088
Fever
Beskrivning

Fever

Datatyp

boolean

Alias
UMLS CUI [1]
C0015967
Pharyngitis
Beskrivning

Pharyngitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0031350
Rhabdomyolysis
Beskrivning

Rhabdomyolysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0035410
Lymphadenopathie
Beskrivning

Lymphadenopathie

Datatyp

boolean

Alias
UMLS CUI [1]
C0497156
Facial Swelling
Beskrivning

Facial Swelling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0015450
Hepatic Abnormalities
Beskrivning

Hepatic Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1]
C4021780
Pulmonary Abnormalities
Beskrivning

Pulmonary Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2709248
UMLS CUI [1,2]
C1704258
Haematological Abnormalities
Beskrivning

Haematological Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C0279810
Cardiac Abnormalities
Beskrivning

Cardiac Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0018787
Renal Abnormalities
Beskrivning

Renal Abnormalities

Datatyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0022646
Conjunctival Abnormalities
Beskrivning

Conjunctival Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0009758
Oral Mucosal Abnormalities
Beskrivning

Oral Mucosal Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0026639
Other Mucosal Abnormalities
Beskrivning

Other Mucosal Abnormalities

Datatyp

boolean

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

Skin Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1123023
Other
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
Haematologic Abnormalities
Beskrivning

Haematologic Abnormalities

Alias
UMLS CUI-1
C0279810
UMLS CUI-2
C1704258
Eosinophilia
Beskrivning

Eosinophilia

Datatyp

boolean

Alias
UMLS CUI [1]
C2240374
Atypical Lymphocytes
Beskrivning

Atypical Lymphocytes

Datatyp

boolean

Alias
UMLS CUI [1]
C0221277
Thrombocytopenia
Beskrivning

Thrombocytopenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0040034
Leucopenia
Beskrivning

Leucopenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023530
Anemia
Beskrivning

Anemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
Neutrophilia
Beskrivning

Neutrophilia

Datatyp

boolean

Alias
UMLS CUI [1]
C0151683
Leukocytosis
Beskrivning

Leukocytosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0023518
Supportive/Investigative Measures
Beskrivning

Supportive/Investigative Measures

Alias
UMLS CUI-1
C0079809
Drug Discontinued
Beskrivning

Drug Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C0558681
IV Steroids
Beskrivning

IV Steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0348016
Oral Steroids
Beskrivning

Oral Steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1527415
Topical Steroids
Beskrivning

Topical Steroids

Datatyp

boolean

Alias
UMLS CUI [1]
C2064827
Hospitalisation Due to Rash
Beskrivning

Hospitalisation Due to Rash

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0015230
Antihistamines
Beskrivning

Antihistamines

Datatyp

boolean

Alias
UMLS CUI [1]
C0003360
Skin Biopsy
Beskrivning

Skin Biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0150866
Photographs
Beskrivning

Photographs

Datatyp

boolean

Alias
UMLS CUI [1]
C0441468
Unknown
Beskrivning

Unknown

Datatyp

boolean

Alias
UMLS CUI [1]
C0439673
Other
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
Diagnosis
Beskrivning

Diagnosis

Alias
UMLS CUI-1
C0011900
Urticaria
Beskrivning

Urticaria

Datatyp

boolean

Alias
UMLS CUI [1]
C0042109
Angioedema
Beskrivning

Angioedema

Datatyp

boolean

Alias
UMLS CUI [1]
C0002994
Stevens-Johnson Syndrome
Beskrivning

Stevens-Johnson Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0038325
Toxic Epidermal Necrolysis
Beskrivning

Toxic Epidermal Necrolysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0014518
Erythema Multiforme Major
Beskrivning

Erythema Multiforme Major

Datatyp

boolean

Alias
UMLS CUI [1]
C0014742
Photosensitivity
Beskrivning

Photosensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0349506
Hypersensitivity
Beskrivning

Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
Morbilliform Rash
Beskrivning

Morbilliform Rash

Datatyp

boolean

Alias
UMLS CUI [1]
C0234918
Unknown
Beskrivning

Unknown

Datatyp

boolean

Alias
UMLS CUI [1]
C0439673
Other
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
Who made the Diagnosis
Beskrivning

Diagnosed by

Datatyp

integer

Alias
UMLS CUI [1]
C0011900
Responsible for Diagnosis
Beskrivning

Responsible for Diagnosis

Alias
UMLS CUI-1
C0680379
UMLS CUI-2
C0011900
Who made the diagnosis?
Beskrivning

Responsible for Diagnosis

Datatyp

integer

Alias
UMLS CUI [1,1]
C0680379
UMLS CUI [1,2]
C0011900
Lesion Location
Beskrivning

Lesion Location

Alias
UMLS CUI-1
C0450429
UMLS CUI-2
C2986546
Face
Beskrivning

Face

Datatyp

boolean

Alias
UMLS CUI [1]
C0015450
Neck
Beskrivning

Neck

Datatyp

boolean

Alias
UMLS CUI [1]
C0027530
Trunk
Beskrivning

Trunk

Datatyp

boolean

Alias
UMLS CUI [1]
C0460005
Upper Extremities
Beskrivning

Upper Extremities

Datatyp

boolean

Alias
UMLS CUI [1]
C0015385
Lower Extremities
Beskrivning

Lower Extremities

Datatyp

boolean

Alias
UMLS CUI [1]
C0023216
Other
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
Concomitant Medication
Beskrivning

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Was the subject taking any other medication at the time of this dermatological adverse event?
Beskrivning

Concomitant Medication

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Beskrivning

Trade Name preferred

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Did this drug contribute to the dermatological drug reaction?
Beskrivning

Contribution to Dermatological Drug Reaction

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0013182
Conclusion
Beskrivning

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beskrivning

Staff initials

Datatyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Dermatological/Hypersensitivity Adverse Event Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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])
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
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)
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])
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])
Item Group
Systemic Symptoms, Signs or Laboratory Abnormalities
C1853129 (UMLS CUI-1)
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])
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])
Haematological Abnormalities
Item
Haematological Abnormalities
boolean
C1853129 (UMLS CUI [1,1])
C0279810 (UMLS CUI [1,2])
Cardiac Abnormalities
Item
Cardiac Abnormalities
boolean
C0018799 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Renal Abnormalities
Item
Renal Abnormalities
text
C1704258 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
Conjunctival Abnormalities
Item
Conjunctival Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0009758 (UMLS CUI [1,2])
Oral Mucosal Abnormalities
Item
Oral Mucosal Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
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])
Skin Pain
Item
Skin Pain
boolean
C0030193 (UMLS CUI [1,1])
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)
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])
Oral Steroids
Item
Oral Steroids
boolean
C0038317 (UMLS CUI [1,1])
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])
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])
Item Group
Diagnosis
C0011900 (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])
Item
Who made the Diagnosis
integer
C0011900 (UMLS CUI [1])
Diagnosed by
Code List
Who made the Diagnosis
CL Item
Investigator (1)
CL Item
Dermatologist (2)
Item Group
Responsible for Diagnosis
C0680379 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
Item
Who made the diagnosis?
integer
C0680379 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Responsible for Diagnosis
Code List
Who made the diagnosis?
CL Item
Investigator (1)
CL Item
Dermatologist (2)
Item Group
Lesion Location
C0450429 (UMLS CUI-1)
C2986546 (UMLS CUI-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 Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Was the subject taking any other medication at the time of this dermatological adverse event?
text
C2347852 (UMLS CUI [1])
Concomitant Medication
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])
Contribution to Dermatological Drug Reaction
Code List
Did this drug contribute to the dermatological drug reaction?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Staff initials
Item
Staff initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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