ID

33622

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 treatment period 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

16. Dezember 2018

DOI

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

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 of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Study Visit
Beschreibung

Study Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
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

If Yes, complete the following items.

Datentyp

text

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

Alias
UMLS CUI [1]
C0019993
Was the drug discontinued?
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0558681
Did the drug reaction resolve after drug disconitnuation?
Beschreibung

Drug Reaction Resolved

Datentyp

text

Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C1527304
UMLS CUI [1,3]
C3714811
Did the reaction reappear with rechallenge?
Beschreibung

Reaction Reappearance

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0277556
Were other systemic symptoms seen?
Beschreibung

If Yes, tick all that apply

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
Physician's Diagnosis
Beschreibung

Physician's Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0031831
Other, specify
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
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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 of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
Item Group
Dermatological Drug Reaction History
C0262926 (UMLS CUI-1)
C0037274 (UMLS CUI-2)
C0041755 (UMLS CUI-3)
Item
Has the subject experienced any type of physician diagnosed dermatologic reaction to any drug?
text
C0262926 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0013182 (UMLS CUI [1,3])
History of Dermatologic Drug Reaction
Code List
Has the subject experienced any type of physician diagnosed dermatologic reaction to any drug?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
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
C0019993 (UMLS CUI [1])
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
C0558681 (UMLS CUI [1])
Drug Discontinuation
Code List
Was the drug discontinued?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
Did the drug reaction resolve after drug disconitnuation?
text
C0558681 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
C3714811 (UMLS CUI [1,3])
Drug Reaction Resolved
Code List
Did the drug reaction resolve after drug disconitnuation?
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])
C0277556 (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
Were other systemic symptoms seen?
text
C2039684 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Systemic Symptoms
Code List
Were 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])
Item
Physician's Diagnosis
integer
C0011900 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Physician's Diagnosis
Code List
Physician's Diagnosis
CL Item
Urticaria (1)
CL Item
Anigoedema (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
Morbiliform Rash (8)
CL Item
Unknown (9)
CL Item
Other, Specify (10)
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
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