ID

33253

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 the subjects history of dermatological drug reactions. It should be filled out at each visit after the screening visit. Complete the Dermatological Drug Reaction History pages for each drug reaction experienced. 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

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  1. 03.12.18 03.12.18 -
  2. 16.12.18 16.12.18 -
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GlaxoSmithKline

Hochgeladen am

3. Dezember 2018

DOI

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Effect of Lamictal on Resting Motor Threshold

Englisch

Dermatological Drug Reaction History

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
Date Information Collected
Beschreibung

Date Information Collected

Datentyp

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008
Dermatological Drug Reaction History
Beschreibung

Dermatological Drug Reaction History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0037274
UMLS CUI-3
C0041755
Has the subject experienced any type of physician diagnosed dermatologic reaction to any drug?
Beschreibung

History of Dermatologic Drug Reaction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0037274
UMLS CUI [1,3]
C0013182
Name of suspect drug implicated (trade name preferred)
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Onset Date of Reaction
Beschreibung

Onset Date of Reaction

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1527304
During what time period after initiation of the drug did the rash occur?
Beschreibung

Tick one box only

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
Was the reaction considered severe?
Beschreibung

Severe Reaction

Datentyp

text

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
Was the subject hospitlaised due to the reaction?
Beschreibung

Hospitalisation

Datentyp

text

Was the drug discontinued?
Beschreibung

If Yes, did the reaction resolve when the drug was discontinued?

Datentyp

text

Did the reaction reappear with rechallenge?
Beschreibung

Reaction Reappearance

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0242656
Where other systemic symptoms seen?
Beschreibung

Other Systemic Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C2039684
UMLS CUI [1,2]
C0205394
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]
C0023895
Pulmonar abnormalities
Beschreibung

Pulmonar abnormalities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0035237
Hematologic Abnormalities
Beschreibung

Hematologic Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0850715
Cardiac Abnormalities
Beschreibung

Cardiac Abnormalities

Datentyp

boolean

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

Renal Abnormalities

Datentyp

boolean

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

Conjunctival Lesions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0009758
Oral Mucosal Abnormalities
Beschreibung

Oral Mucosal Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442027
UMLS CUI [1,2]
C0026724
UMLS CUI [1,3]
C1704258
Other Mucosal Abnormalities
Beschreibung

Other Mucosal Abnormalities

Datentyp

boolean

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

Skin Pain

Datentyp

boolean

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

Other Symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205394
Urticaria
Beschreibung

Urticaria

Datentyp

boolean

Alias
UMLS CUI [1]
C0042109
Angioedema
Beschreibung

Angioedema

Datentyp

boolean

Alias
UMLS CUI [1]
C0002994
Stevens-Johnson Syndrom
Beschreibung

Stevens-Johnson Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0038325
Toxic Epidermal Necrolysis
Beschreibung

Toxic Epidermal Necrolysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0014518
Erythema Multiforme Major
Beschreibung

Erytherma Multiforme Major

Datentyp

boolean

Alias
UMLS CUI [1]
C0014742
Photosensitivity
Beschreibung

Photosensitivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0031762
Hypersensitivity
Beschreibung

Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
Morbiliform Rash
Beschreibung

Morbiliform Rash

Datentyp

boolean

Alias
UMLS CUI [1]
C0015230
Unknown
Beschreibung

Unknown

Datentyp

boolean

Alias
UMLS CUI [1]
C0439673
Other, specify
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
Conclusion
Beschreibung

Conclusion

Alias
UMLS CUI-1
C1707478
Staff initials
Beschreibung

Staff initials

Datentyp

text

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

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Dermatological Drug Reaction History

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])
Date Information Collected
Item
Date Information Collected
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Dermatological Drug Reaction History
C0262926 (UMLS CUI-1)
C0037274 (UMLS CUI-2)
C0041755 (UMLS CUI-3)
History of Dermatologic Drug Reaction
Item
Has the subject experienced any type of physician diagnosed dermatologic reaction to any drug?
boolean
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0013182 (UMLS CUI [1,3])
Drug Name
Item
Name of suspect drug implicated (trade name preferred)
text
C2360065 (UMLS CUI [1])
Onset Date of Reaction
Item
Onset Date of Reaction
date
C0574845 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
Item
During what time period after initiation of the drug did the rash occur?
integer
C0877248 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Period of Rash Occurance
Code List
During what time period after initiation of the drug did the rash occur?
CL Item
Within first 6 weeks (1)
CL Item
After the first 6 weeks (2)
Item
Was the reaction considered severe?
text
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Severe Reaction
Code List
Was the reaction considered severe?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Was the subject hospitlaised due to the reaction?
text
Hospitalisation
Code List
Was the subject hospitlaised due to the reaction?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Was the drug discontinued?
text
Drug Discontinuation
Code List
Was the drug discontinued?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Did the reaction reappear with rechallenge?
text
C0877248 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Reaction Reappearance
Code List
Did the reaction reappear with rechallenge?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Where other systemic symptoms seen?
text
C2039684 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Systemic Symptoms
Code List
Where other systemic symptoms seen?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
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
C0023895 (UMLS CUI [1])
Pulmonar abnormalities
Item
Pulmonar abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
Hematologic Abnormalities
Item
Hematologic Abnormalities
boolean
C0850715 (UMLS CUI [1])
Cardiac Abnormalities
Item
Cardiac Abnormalities
boolean
C0018787 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Renal Abnormalities
Item
Renal Abnormalities
boolean
C0022646 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Conjunctival Lesions
Item
Conjunctival Lesions
boolean
C0221198 (UMLS CUI [1,1])
C0009758 (UMLS CUI [1,2])
Oral Mucosal Abnormalities
Item
Oral Mucosal Abnormalities
boolean
C0442027 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Other Mucosal Abnormalities
Item
Other Mucosal Abnormalities
boolean
C0026724 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Skin Pain
Item
Skin Pain
boolean
C1123023 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Other Symptom
Item
Other Symptom
boolean
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Urticaria
Item
Urticaria
boolean
C0042109 (UMLS CUI [1])
Angioedema
Item
Angioedema
boolean
C0002994 (UMLS CUI [1])
Stevens-Johnson Syndrome
Item
Stevens-Johnson Syndrom
boolean
C0038325 (UMLS CUI [1])
Toxic Epidermal Necrolysis
Item
Toxic Epidermal Necrolysis
boolean
C0014518 (UMLS CUI [1])
Erytherma Multiforme Major
Item
Erythema Multiforme Major
boolean
C0014742 (UMLS CUI [1])
Photosensitivity
Item
Photosensitivity
boolean
C0031762 (UMLS CUI [1])
Hypersensitivity
Item
Hypersensitivity
boolean
C0020517 (UMLS CUI [1])
Morbiliform Rash
Item
Morbiliform Rash
boolean
C0015230 (UMLS CUI [1])
Unknown
Item
Unknown
boolean
C0439673 (UMLS CUI [1])
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
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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