ID

44195

Description

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 any dermatological or hypersensitivity adverse event form. It should be filled out when any of those occur during the study. Record details of any dematological/hypersensitivity adverse event in the appropriate Non-Serious Adverse/Serious Adverse Event section of the CRF. 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

Keywords

Versions (4)
  1. 12/3/18 12/3/18 -
  2. 12/25/18 12/25/18 -
  3. 1/10/19 1/10/19 - Sarah Riepenhausen
  4. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

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

English

Dermatological/Hypersensitivity Adverse Event Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Description

Subject Screening No.

Data type

integer

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

Subject Number

Data type

integer

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

Hypersensitivity Adverse Event Form Completed

Data type

boolean

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

Staff initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
Dermatological/Hypersensitivity Adverse Event
Description

Dermatological/Hypersensitivity Adverse Event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0037274
UMLS CUI-3
C0877248
UMLS CUI-4
C0020517
Was the dermatological adverse event evaluated by a dermatologist?
Description

Adverse Event evaluated by Dermatologist

Data type

boolean

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

Onset Date of Reaction

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0443286
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Systemic Symptoms, Signs or Laboratory Abnormalities
Description

Systemic Symptoms, Signs or Laboratory Abnormalities

Alias
UMLS CUI-1
C1853129
UMLS CUI-3
C0037088
Were other systemic symptoms, signs or laboratory abnormalities seen?
Description

If Yes, tick all that apply

Data type

integer

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0037088
Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Pharyngitis
Description

Pharyngitis

Data type

boolean

Alias
UMLS CUI [1]
C0031350
Rhabdomyolysis
Description

Rhabdomyolysis

Data type

boolean

Alias
UMLS CUI [1]
C0035410
Lymphadenopathy
Description

Lymphadenopathy

Data type

boolean

Alias
UMLS CUI [1]
C0497156
Facial Swelling
Description

Facial Swelling

Data type

boolean

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

Hepatic Abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C4021780
Pulmonary Abnormalities
Description

Pulmonary Abnormalities

Data type

boolean

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

if haematologic abnormalities are present, tick all that apply in the itemgroup Haematologic Abnormalities

Data type

boolean

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

Cardiac Abnormalities

Data type

boolean

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

Renal Abnormalities

Data type

text

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

Conjunctival Abnormalities

Data type

boolean

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

Oral Mucosal Abnormalities

Data type

boolean

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

Other Mucosal Abnormalities

Data type

boolean

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

Skin Pain

Data type

boolean

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

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
If other, specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Haematologic Abnormalities
Description

Haematologic Abnormalities

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

Eosinophilia

Data type

boolean

Alias
UMLS CUI [1]
C2240374
Atypical Lymphocytes
Description

Atypical Lymphocytes

Data type

boolean

Alias
UMLS CUI [1]
C0221277
Thrombocytopenia
Description

Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0040034
Leucopenia
Description

Leucopenia

Data type

boolean

Alias
UMLS CUI [1]
C0023530
Anemia
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
Neutrophilia
Description

Neutrophilia

Data type

boolean

Alias
UMLS CUI [1]
C0151683
Leukocytosis
Description

Leukocytosis

Data type

boolean

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

Supportive/Investigative Measures

Alias
UMLS CUI-1
C0079809
Were supportive and/or investigative measures undertaken to treat the reaction?
Description

Supportive and Investigative Measures to Reaction Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0079809
UMLS CUI [1,2]
C0443286
UMLS CUI [1,3]
C0087111
Drug Discontinued
Description

Drug Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0558681
IV Steroids
Description

IV Steroids

Data type

boolean

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

Oral Steroids

Data type

boolean

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

Topical Steroids

Data type

boolean

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

Hospitalisation Due to Rash

Data type

boolean

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

Antihistamines

Data type

boolean

Alias
UMLS CUI [1]
C0019590
Skin Biopsy
Description

Skin Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0150866
Photographs
Description

Photographs

Data type

boolean

Alias
UMLS CUI [1]
C0441468
Unknown
Description

Unknown

Data type

boolean

Alias
UMLS CUI [1]
C0439673
Other
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
If other, specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Diagnosis
Description

Diagnosis

Alias
UMLS CUI-1
C0011900
Diagnosis
Description

Diagnosis

Data type

integer

Alias
UMLS CUI [1]
C0011900
If other, specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Responsible for Diagnosis
Description

Responsible for Diagnosis

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

Responsible for Diagnosis

Data type

integer

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

Lesion Location

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

Where was the lesion located?

Data type

boolean

Alias
UMLS CUI [1]
C0015450
Neck
Description

Neck

Data type

boolean

Alias
UMLS CUI [1]
C0027530
Trunk
Description

Trunk

Data type

boolean

Alias
UMLS CUI [1]
C0460005
Upper Extremities
Description

Upper Extremities

Data type

boolean

Alias
UMLS CUI [1]
C0015385
Lower Extremities
Description

Lower Extremities

Data type

boolean

Alias
UMLS CUI [1]
C0023216
Other
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
If other, specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Concomitant Medication
Description

Concomitant Medication

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

Concomitant Medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Description

Trade Name preferred

Data type

text

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

Contribution to Dermatological Drug Reaction

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0013182
Infections
Description

Infections

Does the subject have a history of recurrent herpes?
Description

History of Herpes

Data type

boolean

Alias
UMLS CUI [1,1]
C0744883
UMLS CUI [1,2]
C0262926
Does the subject had a recent occurrence of herpes?
Description

Herpes Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0744883
UMLS CUI [1,2]
C0332185
Was an infection present at the time of the rash that could have precipitated the rash?
Description

Infection Present

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0150312
Ebstein Barr
Description

Ebstein Barr

Data type

boolean

Alias
UMLS CUI [1]
C0014644
Cytomegalo
Description

CMV

Data type

boolean

Alias
UMLS CUI [1]
C0582172
Staphylococcus
Description

Staphylococcus

Data type

boolean

Alias
UMLS CUI [1]
C0038170
Streptococcus
Description

Streptococcus

Data type

boolean

Alias
UMLS CUI [1]
C0038402
Other
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
If other, specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's initials
Description

Physician's initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Similar models

Dermatological/Hypersensitivity Adverse Event Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Dermatological/Hypersensitivity Adverse Event
C0877248 (UMLS CUI-1)
C0037274 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0020517 (UMLS CUI-4)
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 [1,1])
C0443286 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Systemic Symptoms, Signs or Laboratory Abnormalities
C1853129 (UMLS CUI-1)
C0037088 (UMLS CUI-3)
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])
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
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
C0018787 (UMLS CUI [1,1])
C1704258 (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
boolean
C0205394 (UMLS CUI [1])
Other Specification
Item
If other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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)
Supportive and Investigative Measures to Reaction Treatment
Item
Were supportive and/or investigative measures undertaken to treat the reaction?
boolean
C0079809 (UMLS CUI [1,1])
C0443286 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
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
C0019590 (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
boolean
C0205394 (UMLS CUI [1])
Other Specification
Item
If other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Diagnosis
C0011900 (UMLS CUI-1)
Item
Diagnosis
integer
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Urticaria (1)
CL Item
Angioedema (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
Morbilliform rash (8)
CL Item
Unknown (9)
CL Item
Other (10)
Other Specification
Item
If other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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
boolean
C0205394 (UMLS CUI [1])
Other Specification
Item
If other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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
Infections
History of Herpes
Item
Does the subject have a history of recurrent herpes?
boolean
C0744883 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Herpes Recent
Item
Does the subject had a recent occurrence of herpes?
boolean
C0744883 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Infection Present
Item
Was an infection present at the time of the rash that could have precipitated the rash?
boolean
C3714514 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Ebstein Barr
Item
Ebstein Barr
boolean
C0014644 (UMLS CUI [1])
CMV
Item
Cytomegalo
boolean
C0582172 (UMLS CUI [1])
Staphylococcus
Item
Staphylococcus
boolean
C0038170 (UMLS CUI [1])
Streptococcus
Item
Streptococcus
boolean
C0038402 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Other Specification
Item
If other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Physician's initials
Item
Physician's initials
text
C2986440 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
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