ID

31927

Description

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Keywords

Versions (3)
  1. 9/15/18 9/15/18 -
  2. 9/27/18 9/27/18 -
  3. 10/8/18 10/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 8, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040

English

Dermatological drug reaction history - Screen

1 forms  
Dermatological drug reaction history
Description

Dermatological drug reaction history

Alias
UMLS CUI-1
C0013182
UMLS CUI-2
C0560169
Date of assessment
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Has this patient experienced any type of physician- diagnosed dermatologic reaction to any dug?
Description

If yes, complete the following. Complete an additional DERMATOLOGICAL DRUG REACTION HISTORY page for each drug reaction experienced.

Data type

integer

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0560169
Name of the drug
Description

Medication name

Data type

text

Alias
UMLS CUI [1]
C2360065
Onset date of reaction
Description

Date of onset; Allergic Reaction

Data type

partialDate

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

Period (temporal qualifier); Pharmaceutical Preparations; Initiation; Allergic Reaction

Data type

integer

Alias
UMLS CUI [1,1]
C1948053
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1704686
UMLS CUI [1,4]
C1527304
Was the reaction considered serious?
Description

Allergic Reaction; Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205404
Was the patient hospitalized due to the reaction?
Description

Allergic Reaction; Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0019993
Was the drug discontinued?
Description

Drug therapy discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0558681
If drug therapy was discontinued, did the reaction resolve wehn the drug was discontinued?
Description

Medication discontinued | Allergic Reaction; Resolved

Data type

boolean

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

Allergic Reaction; Recurrence

Data type

integer

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0034897
Were other systemic symptoms seen?
Description

systemic symptoms; Other

Data type

boolean

Alias
UMLS CUI [1,1]
C2039684
UMLS CUI [1,2]
C0205394
If other systemic symptoms were seen, check all that apply.
Description

systemic symptoms; Other

Data type

integer

Alias
UMLS CUI [1,1]
C2039684
UMLS CUI [1,2]
C0205394
If other systemic symptoms as the ones listed, specify.
Description

systemic symptoms; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C2039684
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Were supportive measures required to treat the reaction?
Description

Supportive care | Allergic Reaction

Data type

boolean

Alias
UMLS CUI [1]
C0344211
UMLS CUI [2]
C1527304
If there were supportive measures required to treat the reaction, check all that apply.
Description

Supportive care | Allergic Reaction

Data type

integer

Alias
UMLS CUI [1]
C0344211
UMLS CUI [2]
C1527304
If there were other supportive measures required to treat the reaction, specify.
Description

Supportive care; Other; Specification | Allergic Reaction

Data type

text

Alias
UMLS CUI [1,1]
C0344211
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
UMLS CUI [2]
C1527304
What was the physician's diagnosis? Check one.
Description

Diagnosis; Physicians

Data type

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0031831
If other physician's diagnosis, specify.
Description

Diagnosis; Physicians; Other; Specification

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Was the patient taking any other medications at the time of this dermatological drug reaction?
Description

Pharmaceutical Preparations; Other | Allergic Reaction; Dermatologic; Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205489
If the patient was taking any other medications at the time of this dermatological drug reaction, did this drug contribute to the dermatological drug reaction?
Description

Pharmaceutical Preparations; Other | Allergic Reaction; Pharmaceutical Preparations; Dermatologic

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205489
If the patient was taking any other medications at the time of this dermatological drug reaction, enter drug name/ generic.
Description

Pharmaceutical Preparations; Other | Allergic Reaction; Pharmaceutical Preparations; Dermatologic | generic drug form

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205489
UMLS CUI [3]
C3242750
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Similar models

Dermatological drug reaction history - Screen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dermatological drug reaction history
C0013182 (UMLS CUI-1)
C0560169 (UMLS CUI-2)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item
Has this patient experienced any type of physician- diagnosed dermatologic reaction to any dug?
integer
C0013182 (UMLS CUI [1,1])
C0560169 (UMLS CUI [1,2])
undefined item
Code List
Has this patient experienced any type of physician- diagnosed dermatologic reaction to any dug?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Medication name
Item
Name of the drug
text
C2360065 (UMLS CUI [1])
Date of onset; Allergic Reaction
Item
Onset date of reaction
partialDate
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
C1948053 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C1527304 (UMLS CUI [1,4])
undefined item
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)
Allergic Reaction; Serious
Item
Was the reaction considered serious?
boolean
C1527304 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Allergic Reaction; Hospitalization
Item
Was the patient hospitalized due to the reaction?
boolean
C1527304 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Drug therapy discontinued
Item
Was the drug discontinued?
boolean
C0558681 (UMLS CUI [1])
Medication discontinued | Allergic Reaction; Resolved
Item
If drug therapy was discontinued, did the reaction resolve wehn the drug was discontinued?
boolean
C0558681 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C3714811 (UMLS CUI [2,2])
Item
Did the reaction reappear with rechallenge?
integer
C1527304 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
undefined item
Code List
Did the reaction reappear with rechallenge?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Drug was not rechellenged (3)
systemic symptoms; Other
Item
Were other systemic symptoms seen?
boolean
C2039684 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
If other systemic symptoms were seen, check all that apply.
integer
C2039684 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
undefined item
Code List
If other systemic symptoms were seen, check all that apply.
CL Item
fever (1)
CL Item
Lymphadenopathy (2)
CL Item
Facial swelling (3)
CL Item
Hematologic abnormalities (4)
CL Item
Hepatologic abnormalities (5)
CL Item
Pulmonary abnormalities (6)
CL Item
Cardiac abnormalities (7)
CL Item
Unknown (8)
CL Item
Other, specify (9)
systemic symptoms; Other; Specification
Item
If other systemic symptoms as the ones listed, specify.
text
C2039684 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Supportive care | Allergic Reaction
Item
Were supportive measures required to treat the reaction?
boolean
C0344211 (UMLS CUI [1])
C1527304 (UMLS CUI [2])
Item
If there were supportive measures required to treat the reaction, check all that apply.
integer
C0344211 (UMLS CUI [1])
C1527304 (UMLS CUI [2])
undefined item
Code List
If there were supportive measures required to treat the reaction, check all that apply.
CL Item
Drug discontinued (1)
CL Item
Sytemic steroids (2)
CL Item
Topical steroids (3)
CL Item
Antihistamines (4)
CL Item
Unknown (5)
CL Item
Other, specify (6)
Supportive care; Other; Specification | Allergic Reaction
Item
If there were other supportive measures required to treat the reaction, specify.
text
C0344211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2])
Item
What was the physician's diagnosis? Check one.
integer
C0011900 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
undefined item
Code List
What was the physician's diagnosis? Check one.
CL Item
Urticaria (1)
CL Item
Angioedema (2)
CL Item
Stevens Johnson Syndrome (3)
CL Item
Toxic Epidermal Necrolysis (4)
CL Item
Photosensitivity (5)
CL Item
Simple morbilliform rash (6)
CL Item
Unknown (7)
CL Item
Other, specify (8)
Diagnosis; Physicians; Other; Specification
Item
If other physician's diagnosis, specify.
text
C0011900 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Pharmaceutical Preparations; Other | Allergic Reaction; Dermatologic; Pharmaceutical Preparations
Item
Was the patient taking any other medications at the time of this dermatological drug reaction?
boolean
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205489 (UMLS CUI [2,3])
Item
If the patient was taking any other medications at the time of this dermatological drug reaction, did this drug contribute to the dermatological drug reaction?
text
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205489 (UMLS CUI [2,3])
undefined item
Code List
If the patient was taking any other medications at the time of this dermatological drug reaction, did this drug contribute to the dermatological drug reaction?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Pharmaceutical Preparations; Other | Allergic Reaction; Pharmaceutical Preparations; Dermatologic | generic drug form
Item
If the patient was taking any other medications at the time of this dermatological drug reaction, enter drug name/ generic.
text
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205489 (UMLS CUI [2,3])
C3242750 (UMLS CUI [3])
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