ID

21155

Beschreibung

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

Stichworte

Versionen (1)
  1. 12/04/2017 12/04/2017 -
Hochgeladen am

12 de abril de 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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HLA-B*5701 And Hypersensitivity To Abacavir ABC Hypersensitivity NCT00373945

Englisch

HLA-B*5701 And Hypersensitivity To Abacavir ABC Hypersensitivity NCT00373945

1 Formulare  
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
Date of Visit/Assessment
Beschreibung

DOV

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Exposure to Abacavir
Beschreibung

Exposure to Abacavir

Alias
UMLS CUI-1
C0663655
UMLS CUI-2
C0332157
Drug subject receiving at the time of abacavir hypersensitivity reaction
Beschreibung

Drug subject receiving at the time of abacavir hypersensitivity reaction

Datentyp

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2,1]
C0663655
UMLS CUI [2,2]
C0020517
Date of first exposure to abacavir for this event
Beschreibung

Date of first exposure to abacavir

Datentyp

date

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0011008
Date of abacavir last dose
Beschreibung

Date of abacavir last dose

Datentyp

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0663655
Prior to current study did the subject receive abacavir
Beschreibung

Prior to current study did the subject receive abacavir

Datentyp

text

Alias
UMLS CUI [1]
C0663655
Was/is a skin rash present with this hypersensitivity reaction?
Beschreibung

skin rash

Datentyp

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0020517
Local or disseminated skin rash?
Beschreibung

Please specify if "Was/is a skin rash present with this hypersensitivity reaction?"=Yes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C2348235
Maximum severity of the skin rash?
Beschreibung

Please specify if "Was/is a skin rash present with this hypersensitivity reaction?"=Yes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [1,2]
C0015230
Was a skin biopsy performed?
Beschreibung

Please specify if "Was/is a skin rash present with this hypersensitivity reaction?"=Yes

Datentyp

text

Alias
UMLS CUI [1]
C0150866
Nature of cutaneous findings, tick all that apply
Beschreibung

cutaneous findings

Datentyp

integer

Alias
UMLS CUI [1]
C0455205
Symptoms associated with this hypersensitivity reaction
Beschreibung

Symptoms associated with this hypersensitivity reaction

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0020517
Fever
Beschreibung

If Yes, please complete information on Vital Signs form

Datentyp

text

Alias
UMLS CUI [1]
C0015967
Fever Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0808070
Fever Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0439793
Rash
Beschreibung

Rash

Datentyp

text

Alias
UMLS CUI [1]
C0015230
Rash Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0808070
Rash Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0439793
Gastrointestinal: Nausea
Beschreibung

Nausea

Datentyp

text

Alias
UMLS CUI [1]
C0027497
Nausea Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0027497
UMLS CUI [1,2]
C0808070
Nausea Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0027497
UMLS CUI [1,2]
C0439793
Gastrointestinal: Vomiting
Beschreibung

Vomiting

Datentyp

text

Alias
UMLS CUI [1]
C0042963
Vomiting Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0808070
Vomiting Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0439793
Gastrointestinal: Diarrhea
Beschreibung

Diarrhea

Datentyp

text

Alias
UMLS CUI [1]
C0011991
Diarrhea Start Date
Beschreibung

If Yes, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0808070
Diarrhea Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0439793
Gastrointestinal: Abdominal pain
Beschreibung

Abdominal pain

Datentyp

text

Alias
UMLS CUI [1]
C0000737
Abdominal pain Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0000737
UMLS CUI [1,2]
C0808070
Abdominal pain Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0000737
UMLS CUI [1,2]
C0439793
Constitutional: Tachycardia
Beschreibung

Tachycardia

Datentyp

text

Alias
UMLS CUI [1]
C0039231
Tachycardia Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0039231
UMLS CUI [1,2]
C0808070
Tachycardia Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039231
UMLS CUI [1,2]
C0439793
Constitutional: Hypotension
Beschreibung

If Yes, please complete information on Vital Signs form

Datentyp

text

Alias
UMLS CUI [1]
C0020649
Hypotension Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C0808070
Hypotension Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C0439793
Constitutional: Malaise
Beschreibung

Malaise

Datentyp

text

Alias
UMLS CUI [1]
C0231218
Malaise Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0231218
UMLS CUI [1,2]
C0808070
Malaise Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0231218
UMLS CUI [1,2]
C0439793
Constitutional: Myalgia
Beschreibung

Myalgia

Datentyp

text

Alias
UMLS CUI [1]
C0231528
Myalgia Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0231528
UMLS CUI [1,2]
C0808070
Myalgia Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0231528
UMLS CUI [1,2]
C0439793
Constitutional: Fatigue
Beschreibung

Fatigue

Datentyp

text

Alias
UMLS CUI [1]
C0015672
Fatigue Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0808070
Fatigue Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0439793
Respiratory: Cough
Beschreibung

Cough

Datentyp

text

Alias
UMLS CUI [1]
C0010200
Cough Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0010200
UMLS CUI [1,2]
C0808070
Cough Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0010200
UMLS CUI [1,2]
C0439793
Respiratory: Pharyngitis
Beschreibung

Pharyngitis

Datentyp

text

Alias
UMLS CUI [1]
C0031350
Pharyngitis Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0031350
UMLS CUI [1,2]
C0808070
Pharyngitis maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031350
UMLS CUI [1,2]
C0439793
Respiratory: Dyspnea
Beschreibung

Dyspnea

Datentyp

text

Alias
UMLS CUI [1]
C0013404
Dyspnea Start Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0808070
Dyspnea Maximum Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0439793
Other Symptoms, specify
Beschreibung

Other Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205394
Is symptom associated with this hypersensitivity reaction?
Beschreibung

Other Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0020517
Other Symptoms, Date
Beschreibung

If Yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0808070
Other Symptoms, Max Toxicity
Beschreibung

If Yes, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439793
HRS Vital Signs
Beschreibung

HRS Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure (sitting)
Beschreibung

Last systolic blood pressure recorded prior to HSR

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure (sitting)
Beschreibung

Last diastolic blood pressure recorded prior to HSR

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Systolic blood pressure during HSR clinic visit
Beschreibung

If multiple readings are available, please enter the lowest

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure during HSR clinic visit
Beschreibung

If multiple readings are available, please enter the lowest

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature (oral)
Beschreibung

If multiple readings are available, please enter the highest

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Antiretroviral Therapy
Beschreibung

Antiretroviral Therapy

Alias
UMLS CUI-1
C1963724
Sequence Number
Beschreibung

Sequence Number

Datentyp

text

Alias
UMLS CUI [1]
C2348184
UMLS CUI [2]
C1963724
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C1963724
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
UMLS CUI [2]
C1963724
GSK Drug synonym
Beschreibung

Drug synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
UMLS CUI [2]
C1963724
GSK drug collection code
Beschreibung

drug collection code

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
UMLS CUI [2]
C1963724
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C1963724
Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C1963724
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
UMLS CUI [2]
C1963724
Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
UMLS CUI [2]
C1963724
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
UMLS CUI [2]
C1963724
Ongoing?
Beschreibung

Ongoing?

Datentyp

text

Alias
UMLS CUI [2]
C1963724
End Date
Beschreibung

If not ongoing please specify End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
UMLS CUI [2]
C1963724
CMPRIOR1
Beschreibung

CMPRIOR1

Datentyp

text

Alias
UMLS CUI [2]
C1963724
Medication Type
Beschreibung

Medication Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C1963724
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschreibung

Sequence Number

Datentyp

text

Alias
UMLS CUI [1]
C2348184
UMLS CUI [2]
C2347852
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C2347852
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
UMLS CUI [2]
C2347852
GSK Drug synonym
Beschreibung

GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
UMLS CUI [2]
C2347852
GSK drug collection code
Beschreibung

GSK drug collection code

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
UMLS CUI [2]
C2347852
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C2347852
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
UMLS CUI [2]
C2347852
Ongoing?
Beschreibung

Ongoing

Datentyp

text

Alias
UMLS CUI [1]
C0549178
UMLS CUI [2]
C2347852
End Date
Beschreibung

If not ongoing please specify End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
UMLS CUI [2]
C2347852
Medication Type
Beschreibung

Medication Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C2347852
CDC Classification
Beschreibung

CDC Classification

Alias
UMLS CUI-1
C2319244
Adult CDC Classification of abacavir containing product
Beschreibung

Category A=Asymptomatic HIV infection / Persistent generalised lymphadenopathy / Acute (primary) HIV infection with accompanying illness or history of acute HIV Category B=Symptomatic (non-AIDS) conditions Category C=AIDS indicator conditions as defined by diagnostics or presumptive measures

Datentyp

text

Alias
UMLS CUI [1]
C2319244
ABC HSR Source
Beschreibung

ABC HSR Source

Did the subject experience ABC HSR in a pervious GSK clinical trial/study?
Beschreibung

experience ABC HSR in a pervious GSK

Datentyp

text

Previous Study Identifier/Protocol Number/Identifier
Beschreibung

Please specify if "Did the subject experience ABC HSR in a pervious GSK clinical trial/study?"=Yes

Datentyp

text

Alias
UMLS CUI [1,1]
C2826693
UMLS CUI [1,2]
C2242969
Previous Patient/Subject Number/Identifier
Beschreibung

Please specify if "Did the subject experience ABC HSR in a pervious GSK clinical trial/study?"=Yes

Datentyp

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2242969
No, how did this subject receive abacavir? Please indicate one of the options below:
Beschreibung

Please specify if "Did the subject experience ABC HSR in a pervious GSK clinical trial/study?"=No

Datentyp

integer

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C1514756
UMLS CUI [2]
C2242969
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Ähnliche Modelle

HLA-B*5701 And Hypersensitivity To Abacavir ABC Hypersensitivity NCT00373945

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
DOV
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Exposure to Abacavir
C0663655 (UMLS CUI-1)
C0332157 (UMLS CUI-2)
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])
Drug subject receiving at the time of abacavir hypersensitivity recation
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])
Date of abacavir last dose
Item
Date of abacavir last dose
date
C1762893 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
Item
Prior to current study did the subject receive abacavir
text
C0663655 (UMLS CUI [1])
Prior to current study did the subject receive abacavir
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])
skin rash
Code List
Was/is a skin rash present with this hypersensitivity reaction?
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])
skin rash specification
Code List
Local or disseminated skin rash?
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])
skin rash specification
Code List
Maximum severity of the skin rash?
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Was a skin biopsy performed?
text
C0150866 (UMLS CUI [1])
skin biopsy
Code List
Was a skin biopsy performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Nature of cutaneous findings, tick all that apply
integer
C0455205 (UMLS CUI [1])
Nature of cutaneous findings
Code List
Nature of cutaneous findings, tick all that apply
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)
Item
Fever
text
C0015967 (UMLS CUI [1])
Fever
Code List
Fever
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])
Item
Fever Maximum Toxicity
integer
C0015967 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Fever Maximum Toxicity
Code List
Fever Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Rash
text
C0015230 (UMLS CUI [1])
Rash
Code List
Rash
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])
Item
Rash Maximum Toxicity
integer
C0015230 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Rash Maximum Toxicity
Code List
Rash Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Nausea
text
C0027497 (UMLS CUI [1])
Nausea
Code List
Gastrointestinal: Nausea
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])
Item
Nausea Maximum Toxicity
integer
C0027497 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Nausea Maximum Toxicity
Code List
Nausea Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Vomiting
text
C0042963 (UMLS CUI [1])
Vomiting
Code List
Gastrointestinal: Vomiting
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])
Item
Vomiting Maximum Toxicity
integer
C0042963 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Vomiting Maximum Toxicity
Code List
Vomiting Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Diarrhea
text
C0011991 (UMLS CUI [1])
Diarrhea
Code List
Gastrointestinal: Diarrhea
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])
Item
Diarrhea Maximum Toxicity
integer
C0011991 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Diarrhea Maximum Toxicity
Code List
Diarrhea Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Abdominal pain
text
C0000737 (UMLS CUI [1])
Abdominal pain
Code List
Gastrointestinal: Abdominal pain
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])
Item
Abdominal pain Maximum Toxicity
integer
C0000737 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Abdominal pain Maximum Toxicity
Code List
Abdominal pain Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Tachycardia
text
C0039231 (UMLS CUI [1])
Tachycardia
Code List
Constitutional: Tachycardia
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])
Item
Tachycardia Maximum Toxicity
integer
C0039231 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Tachycardia Maximum Toxicity
Code List
Tachycardia Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Hypotension
text
C0020649 (UMLS CUI [1])
Hypotension
Code List
Constitutional: Hypotension
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])
Item
Hypotension Maximum Toxicity
integer
C0020649 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Hypotension Maximum Toxicity
Code List
Hypotension Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Malaise
text
C0231218 (UMLS CUI [1])
Malaise
Code List
Constitutional: Malaise
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])
Item
Malaise Maximum Toxicity
integer
C0231218 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Malaise Maximum Toxicity
Code List
Malaise Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Myalgia
text
C0231528 (UMLS CUI [1])
Myalgia
Code List
Constitutional: Myalgia
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])
Item
Myalgia Maximum Toxicity
integer
C0231528 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Myalgia Maximum Toxicity
Code List
Myalgia Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Fatigue
text
C0015672 (UMLS CUI [1])
Fatigue
Code List
Constitutional: Fatigue
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])
Item
Fatigue Maximum Toxicity
integer
C0015672 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Fatigue Maximum Toxicity
Code List
Fatigue Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Respiratory: Cough
text
C0010200 (UMLS CUI [1])
Cough
Code List
Respiratory: Cough
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])
Item
Cough Maximum Toxicity
integer
C0010200 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Cough Maximum Toxicity
Code List
Cough Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Respiratory: Pharyngitis
text
C0031350 (UMLS CUI [1])
Pharyngitis
Code List
Respiratory: Pharyngitis
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])
Item
Pharyngitis maximum Toxicity
integer
C0031350 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Pharyngitis maximum Toxicity
Code List
Pharyngitis maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Respiratory: Dyspnea
text
C0013404 (UMLS CUI [1])
Dyspnea
Code List
Respiratory: Dyspnea
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])
Item
Dyspnea Maximum Toxicity
integer
C0013404 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Dyspnea Maximum Toxicity
Code List
Dyspnea Maximum Toxicity
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])
Item
Is symptom associated with this hypersensitivity reaction?
text
C1457887 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Other Symptoms
Code List
Is symptom associated with this hypersensitivity reaction?
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])
Item
Other Symptoms, Max Toxicity
integer
C1457887 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Other Symptoms
Code List
Other Symptoms, Max Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item Group
HRS Vital Signs
C0518766 (UMLS CUI-1)
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])
Item Group
Antiretroviral Therapy
C1963724 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
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])
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])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
Item
Units
text
C1519795 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
Units
Code List
Units
CL Item
Milligram (MG)
CL Item
Capsule (CAP)
CL Item
Tablet (TAB)
CL Item
Millilitre (ML)
CL Item
Gram (G)
CL Item
Unknown (UNK)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
C1963724 (UMLS CUI [2])
Frequency
Code List
Frequency
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])
Item
Ongoing?
text
C1963724 (UMLS CUI [2])
Ongoing?
Code List
Ongoing?
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])
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])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
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])
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])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Item
Ongoing?
text
C0549178 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Ongoing?
Code List
Ongoing?
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])
Medication Type
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Item Group
CDC Classification
C2319244 (UMLS CUI-1)
Item
Adult CDC Classification of abacavir containing product
text
C2319244 (UMLS CUI [1])
CDC Classification
Code List
Adult CDC Classification of abacavir containing product
CL Item
Category A (A)
CL Item
Category B (B)
CL Item
Category C (C)
Item Group
ABC HSR Source
Item
Did the subject experience ABC HSR in a pervious GSK clinical trial/study?
text
undefined item
Code List
Did the subject experience ABC HSR in a pervious GSK clinical trial/study?
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])
Previous subject identifier
Item
Previous Patient/Subject Number/Identifier
text
C2348585 (UMLS CUI [1,1])
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])
receive abacavir
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)
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