Informatie:
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ID
21155
Beschrijving
A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir Assessment: ABC Hypersensitivity NCT00373945 / VIIV-ABC107442 Annotated Design For Trial:abc442_lgm Protocol:ABC107442 Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus I, Phase: 4, Clinical Study ID: ABC107442, Sponsor: ViiV
Trefwoorden
Versies (1)
- 12-04-17 12-04-17 -
Geüploaded op
12 april 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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HLA-B*5701 And Hypersensitivity To Abacavir ABC Hypersensitivity NCT00373945
HLA-B*5701 And Hypersensitivity To Abacavir ABC Hypersensitivity NCT00373945
Similar models
HLA-B*5701 And Hypersensitivity To Abacavir ABC Hypersensitivity NCT00373945
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
DOV
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item
Drug subject receiving at the time of abacavir hypersensitivity reaction
integer
C0013227 (UMLS CUI [1])
C0663655 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0663655 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
Code List
Drug subject receiving at the time of abacavir hypersensitivity reaction
CL Item
Trizivir (1)
CL Item
Ziagen (2)
CL Item
Abacavir/lamivudine fixed dose combination (3)
Date of first exposure to abacavir
Item
Date of first exposure to abacavir for this event
date
C0663655 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0332157 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of abacavir last dose
Item
Date of abacavir last dose
date
C1762893 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C0663655 (UMLS CUI [1,2])
Item
Prior to current study did the subject receive abacavir
text
C0663655 (UMLS CUI [1])
Code List
Prior to current study did the subject receive abacavir
CL Item
Yes (Y)
Item
Was/is a skin rash present with this hypersensitivity reaction?
text
C0015230 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
CL Item
No (N)
CL Item
Yes (Y)
Item
Local or disseminated skin rash?
integer
C0015230 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
local (1)
CL Item
disseminated (2)
Item
Maximum severity of the skin rash?
integer
C0439793 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0015230 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Item
Nature of cutaneous findings, tick all that apply
integer
C0455205 (UMLS CUI [1])
CL Item
Pruritus (1)
CL Item
Urticaria (2)
CL Item
Erythema Multiforme (3)
CL Item
Toxic epidermal necrolysis (4)
CL Item
Moist desquamation (5)
CL Item
Mucous membrane involvement (6)
CL Item
Exfoliative dermatitis (7)
CL Item
Fixed drug eruption (8)
CL Item
Scarlatiniform rash (9)
CL Item
Target lesions (10)
CL Item
Ulceration (11)
CL Item
Necrosis requiring surgery (12)
CL Item
Vesiculobullous (13)
CL Item
Macular of Maculopapular Rash (14)
CL Item
Stevens-Johnson syndrome (15)
CL Item
Dry desquamation (16)
CL Item
Vesicular (17)
CL Item
Erythema (18)
Item Group
Symptoms associated with this hypersensitivity reaction
C1457887 (UMLS CUI-1)
C0020517 (UMLS CUI-2)
C0020517 (UMLS CUI-2)
CL Item
No (N)
CL Item
Yes (Y)
Fever Start Date
Item
Fever Start Date
date
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Fever Maximum Toxicity
integer
C0015967 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
No (N)
CL Item
Yes (Y)
Rash Start Date
Item
Rash Start Date
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Rash Maximum Toxicity
integer
C0015230 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Nausea Start Date
Item
Nausea Start Date
date
C0027497 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Nausea Maximum Toxicity
integer
C0027497 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Vomiting Start Date
Item
Vomiting Start Date
date
C0042963 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Vomiting Maximum Toxicity
integer
C0042963 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Diarrhea Start Date
Item
Diarrhea Start Date
text
C0011991 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Diarrhea Maximum Toxicity
integer
C0011991 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Abdominal pain Start Date
Item
Abdominal pain Start Date
date
C0000737 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Abdominal pain Maximum Toxicity
integer
C0000737 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Tachycardia Start Date
Item
Tachycardia Start Date
date
C0039231 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Tachycardia Maximum Toxicity
integer
C0039231 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Hypotension Start Date
Item
Hypotension Start Date
date
C0020649 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Hypotension Maximum Toxicity
integer
C0020649 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Malaise Start Date
Item
Malaise Start Date
date
C0231218 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Malaise Maximum Toxicity
integer
C0231218 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Myalgia Start Date
Item
Myalgia Start Date
date
C0231528 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Myalgia Maximum Toxicity
integer
C0231528 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Fatigue Start Date
Item
Fatigue Start Date
date
C0015672 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Fatigue Maximum Toxicity
integer
C0015672 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Cough Start Date
Item
Cough Start Date
date
C0010200 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Cough Maximum Toxicity
integer
C0010200 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Pharyngitis Start Date
Item
Pharyngitis Start Date
date
C0031350 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Pharyngitis maximum Toxicity
integer
C0031350 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Yes (Y)
CL Item
No (N)
Dyspnea Start Date
Item
Dyspnea Start Date
date
C0013404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Dyspnea Maximum Toxicity
integer
C0013404 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Other Symptoms
Item
Other Symptoms, specify
text
C1457887 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
Is symptom associated with this hypersensitivity reaction?
text
C1457887 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
CL Item
Yes (Y)
CL Item
No (N)
Other Symptoms
Item
Other Symptoms, Date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Other Symptoms, Max Toxicity
integer
C1457887 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
systolic blood Pressure
Item
Systolic Blood Pressure (sitting)
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Diastolic Blood Pressure (sitting)
integer
C0428883 (UMLS CUI [1])
systolic blood pressure
Item
Systolic blood pressure during HSR clinic visit
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure during HSR clinic visit
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature (oral)
float
C0005903 (UMLS CUI [1])
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
C1963724 (UMLS CUI [2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
C1963724 (UMLS CUI [2])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
C1963724 (UMLS CUI [2])
Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2])
C0871468 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2])
drug collection code
Item
GSK drug collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1963724 (UMLS CUI [2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1963724 (UMLS CUI [2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2])
C0231175 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
C1963724 (UMLS CUI [2])
CL Item
Milligram (MG)
CL Item
Capsule (CAP)
CL Item
Tablet (TAB)
CL Item
Millilitre (ML)
CL Item
Gram (G)
CL Item
Unknown (UNK)
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per week (4)
CL Item
5 times per day (5)
CL Item
Continuous infusion (6)
CL Item
Every 2 weeks (7)
CL Item
Every 3 weeks (8)
CL Item
Every 3 months (9)
CL Item
Every other day (10)
CL Item
At Bedtime (11)
CL Item
Once a month (12)
CL Item
Once a week (13)
CL Item
Once daily (14)
CL Item
Once only (15)
CL Item
Unknown (16)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
C1963724 (UMLS CUI [2])
CL Item
Yes (Y)
CL Item
No, specify End Date (N)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
C1963724 (UMLS CUI [2])
CMPRIOR1
Item
CMPRIOR1
text
C1963724 (UMLS CUI [2])
Medication Type
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2])
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0871468 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
GSK drug collection code
Item
GSK drug collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
CL Item
Yes (Y)
CL Item
No, specify End Date (N)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Medication Type
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Item
Adult CDC Classification of abacavir containing product
text
C2319244 (UMLS CUI [1])
CL Item
Category A (A)
CL Item
Category B (B)
CL Item
Category C (C)
Item
Did the subject experience ABC HSR in a pervious GSK clinical trial/study?
text
CL Item
Yes (Y)
CL Item
No (N)
Previous study identifier
Item
Previous Study Identifier/Protocol Number/Identifier
text
C2826693 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,2])
Previous subject identifier
Item
Previous Patient/Subject Number/Identifier
text
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,2])
Item
No, how did this subject receive abacavir? Please indicate one of the options below:
integer
C0663655 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C2242969 (UMLS CUI [2])
C1514756 (UMLS CUI [1,2])
C2242969 (UMLS CUI [2])
Code List
No, how did this subject receive abacavir? Please indicate one of the options below:
CL Item
Prescription (1)
CL Item
Named patient/Special access programs (2)
CL Item
Other, please specify (3)