ID

34004

Beschreibung

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

Stichworte

Versionen (4)
  1. 03.12.18 03.12.18 -
  2. 25.12.18 25.12.18 -
  3. 10.01.19 10.01.19 - Sarah Riepenhausen
  4. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Januar 2019

DOI

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

Dermatological/Hypersensitivity Adverse Event Form

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

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

Subject Number

Datentyp

integer

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

Hypersensitivity Adverse Event Form Completed

Datentyp

boolean

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

Staff initials

Datentyp

text

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

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?
Beschreibung

Adverse Event evaluated by Dermatologist

Datentyp

boolean

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

Onset Date of Reaction

Datentyp

date

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

Date of Assessment

Datentyp

date

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

Systemic Symptoms, Signs or Laboratory Abnormalities

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

If Yes, tick all that apply

Datentyp

integer

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

Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Pharyngitis
Beschreibung

Pharyngitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0031350
Rhabdomyolysis
Beschreibung

Rhabdomyolysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0035410
Lymphadenopathy
Beschreibung

Lymphadenopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0497156
Facial Swelling
Beschreibung

Facial Swelling

Datentyp

boolean

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

Hepatic Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C4021780
Pulmonary Abnormalities
Beschreibung

Pulmonary Abnormalities

Datentyp

boolean

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

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

Datentyp

boolean

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

Cardiac Abnormalities

Datentyp

boolean

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

Renal Abnormalities

Datentyp

text

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

Conjunctival Abnormalities

Datentyp

boolean

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

Oral Mucosal Abnormalities

Datentyp

boolean

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

Other Mucosal Abnormalities

Datentyp

boolean

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

Skin Pain

Datentyp

boolean

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

Other

Datentyp

boolean

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

Other Specification

Datentyp

text

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

Haematologic Abnormalities

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

Eosinophilia

Datentyp

boolean

Alias
UMLS CUI [1]
C2240374
Atypical Lymphocytes
Beschreibung

Atypical Lymphocytes

Datentyp

boolean

Alias
UMLS CUI [1]
C0221277
Thrombocytopenia
Beschreibung

Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
Leucopenia
Beschreibung

Leucopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023530
Anemia
Beschreibung

Anemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0002871
Neutrophilia
Beschreibung

Neutrophilia

Datentyp

boolean

Alias
UMLS CUI [1]
C0151683
Leukocytosis
Beschreibung

Leukocytosis

Datentyp

boolean

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

Supportive/Investigative Measures

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

Supportive and Investigative Measures to Reaction Treatment

Datentyp

boolean

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

Drug Discontinued

Datentyp

boolean

Alias
UMLS CUI [1]
C0558681
IV Steroids
Beschreibung

IV Steroids

Datentyp

boolean

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

Oral Steroids

Datentyp

boolean

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

Topical Steroids

Datentyp

boolean

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

Hospitalisation Due to Rash

Datentyp

boolean

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

Antihistamines

Datentyp

boolean

Alias
UMLS CUI [1]
C0003360
Skin Biopsy
Beschreibung

Skin Biopsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0150866
Photographs
Beschreibung

Photographs

Datentyp

boolean

Alias
UMLS CUI [1]
C0441468
Unknown
Beschreibung

Unknown

Datentyp

boolean

Alias
UMLS CUI [1]
C0439673
Other
Beschreibung

Other

Datentyp

boolean

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

Other Specification

Datentyp

text

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

Diagnosis

Alias
UMLS CUI-1
C0011900
Diagnosis
Beschreibung

Diagnosis

Datentyp

integer

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

Other Specification

Datentyp

text

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

Responsible for Diagnosis

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

Responsible for Diagnosis

Datentyp

integer

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

Lesion Location

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

Where was the lesion located?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015450
Neck
Beschreibung

Neck

Datentyp

boolean

Alias
UMLS CUI [1]
C0027530
Trunk
Beschreibung

Trunk

Datentyp

boolean

Alias
UMLS CUI [1]
C0460005
Upper Extremities
Beschreibung

Upper Extremities

Datentyp

boolean

Alias
UMLS CUI [1]
C0015385
Lower Extremities
Beschreibung

Lower Extremities

Datentyp

boolean

Alias
UMLS CUI [1]
C0023216
Other
Beschreibung

Other

Datentyp

boolean

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

Other Specification

Datentyp

text

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

Concomitant Medication

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

Concomitant Medication

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

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

Contribution to Dermatological Drug Reaction

Datentyp

text

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

Infections

Does the subject have a history of recurrent herpes?
Beschreibung

History of Herpes

Datentyp

boolean

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

Herpes Recent

Datentyp

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?
Beschreibung

Infection Present

Datentyp

boolean

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

Ebstein Barr

Datentyp

boolean

Alias
UMLS CUI [1]
C0014644
Cytomegalo
Beschreibung

CMV

Datentyp

boolean

Alias
UMLS CUI [1]
C0582172
Staphylococcus
Beschreibung

Staphylococcus

Datentyp

boolean

Alias
UMLS CUI [1]
C0038170
Streptococcus
Beschreibung

Streptococcus

Datentyp

boolean

Alias
UMLS CUI [1]
C0038402
Other
Beschreibung

Other

Datentyp

boolean

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

Other Specification

Datentyp

text

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

Conclusion

Alias
UMLS CUI-1
C1707478
Physician's initials
Beschreibung

Physician's initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1552089
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Ähnliche Modelle

Dermatological/Hypersensitivity Adverse Event Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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
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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