ID

21393

Description

NCT00340080 / VIIV-CNA106030 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Abacavir Hypersensitivity Reaction Record Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Keywords

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  1. 4/19/17 4/19/17 -
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Genetic Screening For HLA-B*5701 in Patients with HIV Abacavir Hypersensitivity Reaction Record NCT00340080

English

Genetic Screening For HLA-B*5701 Abacavir Hypersensitivity Reaction Record NCT00340080

1 forms  
Abacavir Hypersensitivity Reaction Record
Description

Abacavir Hypersensitivity Reaction Record

Alias
UMLS CUI-1
C0020517
UMLS CUI-2
C0663655
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Drug subject was receiving at the time of the abacavir hypersensitivity reaction, check one
Description

Exposure to Abacavir

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0020517
Date of first exposure to abacavir for this study
Description

Date of first exposure to abacavir for this study

Data type

date

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0808070
Date of abacavir last dose
Description

Date of abacavir last dose

Data type

date

Alias
UMLS CUI [1,1]
C0663655
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0806020
Prior to current study, did the subject receive abacavir-containing product?
Description

Prior to current study, did the subject receive abacavir-containing product?

Data type

text

Alias
UMLS CUI [1]
C0663655
Does the subject have a history of drug allergy?
Description

drug allergy

Data type

text

Alias
UMLS CUI [1]
C0013182
Drug Name (Trade Name preferred)
Description

If Yes, specify drug(s) below:

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013182
Is the subject aware of any immediate family members who have a history of drug allergy?
Description

Family allergy history

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0013182
Asthma
Description

Does the subject or any of the subject’s family members have any of the following? Check 􏰀all that apply

Data type

integer

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0241889
Hay Fever
Description

Does the subject or any of the subject’s family members have any of the following? Check 􏰀all that apply

Data type

integer

Alias
UMLS CUI [1]
C0018621
UMLS CUI [2]
C0241889
Eczema
Description

Does the subject or any of the subject’s family members have any of the following? Check 􏰀all that apply

Data type

integer

Alias
UMLS CUI [1]
C0013595
UMLS CUI [2]
C0241889
Was/is a skin rash present with this hypersensitivity reaction?
Description

skin rash

Data type

text

Alias
UMLS CUI [1]
C0015230
Local or disseminated skin rash, check 􏰀one
Description

If Yes, complete below.

Data type

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C2348235
Nature of cutaneous findings, check all that apply
Description

If Yes, complete below.

Data type

integer

Alias
UMLS CUI [1]
C0455205
Fever. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Symptoms associated with this hypersensitivity reaction, complete each row

Data type

text

Fever Start Date
Description

If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0808070
Fever Maximum Toxicity or Intnsity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0439793
Rash. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Rash

Data type

text

Alias
UMLS CUI [1]
C0015230
Rash Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0439793
Gastrointestinal: Nausea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Nausea

Data type

text

Alias
UMLS CUI [1]
C0027497
Nausea Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0027497
UMLS CUI [1,2]
C0439793
Gastrointestinal: Vomiting. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Vomiting

Data type

text

Alias
UMLS CUI [1]
C0042963
Vomiting Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0439793
Gastrointestinal: Diarrhea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Diarrhea

Data type

text

Alias
UMLS CUI [1]
C0011991
Diarrhea Start Date
Description

If Yes, please specify

Data type

text

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0439793
Gastrointestinal: Abdominal pain. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Abdominal pain

Data type

text

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

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0000737
UMLS CUI [1,2]
C0439793
Constitutional: Tachycardia. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Tachycardia

Data type

text

Alias
UMLS CUI [1]
C0039231
Tachycardia Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0039231
UMLS CUI [1,2]
C0439793
Constitutional: Hypotension. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Hypotension

Data type

text

Alias
UMLS CUI [1]
C0020649
Hypotension Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C0439793
Constitutional: Malaise. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Malaise

Data type

text

Alias
UMLS CUI [1]
C0231218
Malaise Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0231218
UMLS CUI [1,2]
C0439793
Constitutional: Myalgia. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Myalgia

Data type

text

Alias
UMLS CUI [1]
C0231528
Myalgia Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0231528
UMLS CUI [1,2]
C0439793
Constitutional: Fatigue. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Fatigue

Data type

text

Alias
UMLS CUI [1]
C0015672
Fatigue Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0439793
Respiratory: Cough. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Cough

Data type

text

Alias
UMLS CUI [1]
C0010200
Cough Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0010200
UMLS CUI [1,2]
C0439793
Respiratory: Pharyngitis. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Pharyngitis

Data type

text

Alias
UMLS CUI [1]
C0031350
Pharyngitis Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0031350
UMLS CUI [1,2]
C0439793
Respiratory: Dyspnea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
Description

Dyspnea

Data type

text

Alias
UMLS CUI [1]
C0013404
Dyspnea Start Date
Description

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

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

Other Symptoms

Data type

text

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

Other Symptoms

Data type

text

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

If Yes, please specify

Data type

date

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

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439793
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Investigator’s signature
Description

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator’s signature date
Description

Investigator’s signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator’s name (print)
Description

Investigator’s name

Data type

text

Alias
UMLS CUI [1]
C2346576
Since the previous scheduled study visit, did the subject use any of the health care services listed below due to HIV-associated conditions, adverse events, or serious adverse events including HSR.
Description

health care services

Data type

text

Alias
UMLS CUI [1]
C0086388
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Genetic Screening For HLA-B*5701 Abacavir Hypersensitivity Reaction Record NCT00340080

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Abacavir Hypersensitivity Reaction Record
C0020517 (UMLS CUI-1)
C0663655 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item
Drug subject was receiving at the time of the abacavir hypersensitivity reaction, check one
integer
C0013227 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Exposure to Abacavir
Code List
Drug subject was receiving at the time of the abacavir hypersensitivity reaction, check one
CL Item
TRIZIVIR (1)
CL Item
ZIAGEN (2)
CL Item
EPZICOM/KIVEXA (3)
Date of first exposure to abacavir for this study
Item
Date of first exposure to abacavir for this study
date
C0663655 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Date of abacavir last dose
Item
Date of abacavir last dose
date
C0663655 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Prior to current study, did the subject receive abacavir-containing product?
text
C0663655 (UMLS CUI [1])
Prior to current study, did the subject receive abacavir-containing product?
Code List
Prior to current study, did the subject receive abacavir-containing product?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item
Does the subject have a history of drug allergy?
text
C0013182 (UMLS CUI [1])
drug allergy
Code List
Does the subject have a history of drug allergy?
CL Item
Yes (Y)
CL Item
No (N)
drug allergy
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1,1])
C0013182 (UMLS CUI [1,2])
Item
Is the subject aware of any immediate family members who have a history of drug allergy?
text
C0241889 (UMLS CUI [1,1])
C0013182 (UMLS CUI [1,2])
drug allergy
Code List
Is the subject aware of any immediate family members who have a history of drug allergy?
CL Item
Yes (Y)
CL Item
No (N)
Item
Asthma
integer
C0004096 (UMLS CUI [1])
C0241889 (UMLS CUI [2])
Asthma
Code List
Asthma
CL Item
Subject (1)
CL Item
Subject's Parent(s) (2)
CL Item
Subject's Sibling(s) (3)
CL Item
Subject's Child(ren) (4)
Item
Hay Fever
integer
C0018621 (UMLS CUI [1])
C0241889 (UMLS CUI [2])
Asthma
Code List
Hay Fever
CL Item
Subject (1)
CL Item
Subject's Parent(s) (2)
CL Item
Subject's Sibling(s) (3)
CL Item
Subject's Child(ren) (4)
Item
Eczema
integer
C0013595 (UMLS CUI [1])
C0241889 (UMLS CUI [2])
Asthma
Code List
Eczema
CL Item
Subject (1)
CL Item
Subject's Parent(s) (2)
CL Item
Subject's Sibling(s) (3)
CL Item
Subject's Child(ren) (4)
Item
Was/is a skin rash present with this hypersensitivity reaction?
text
C0015230 (UMLS CUI [1])
drug allergy
Code List
Was/is a skin rash present with this hypersensitivity reaction?
CL Item
Yes (Y)
CL Item
No (N)
Item
Local or disseminated skin rash, check 􏰀one
integer
C0015230 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Local or disseminated skin rash
Code List
Local or disseminated skin rash, check 􏰀one
CL Item
local (1)
CL Item
disseminated (2)
Item
Nature of cutaneous findings, check all that apply
integer
C0455205 (UMLS CUI [1])
cutaneous findings
Code List
Nature of cutaneous findings, check 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
Fever. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
drug allergy
Code List
Fever. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
CL Item
Yes (Y)
CL Item
No (N)
Fever Start Date
Item
Fever Start Date
date
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Fever Maximum Toxicity or Intnsity
integer
C0015967 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Fever Maximum Toxicity
Code List
Fever Maximum Toxicity or Intnsity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Rash. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0015230 (UMLS CUI [1])
Rash
Code List
Rash. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Rash Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Nausea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0027497 (UMLS CUI [1])
Nausea
Code List
Gastrointestinal: Nausea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Nausea Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Vomiting. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0042963 (UMLS CUI [1])
Vomiting
Code List
Gastrointestinal: Vomiting. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Vomiting Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Diarrhea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0011991 (UMLS CUI [1])
Diarrhea
Code List
Gastrointestinal: Diarrhea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Diarrhea Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Gastrointestinal: Abdominal pain. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0000737 (UMLS CUI [1])
Abdominal pain
Code List
Gastrointestinal: Abdominal pain. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Abdominal pain Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Tachycardia. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0039231 (UMLS CUI [1])
Tachycardia
Code List
Constitutional: Tachycardia. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Tachycardia Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Hypotension. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0020649 (UMLS CUI [1])
Hypotension
Code List
Constitutional: Hypotension. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Hypotension Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Malaise. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0231218 (UMLS CUI [1])
Malaise
Code List
Constitutional: Malaise. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Malaise Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Myalgia. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0231528 (UMLS CUI [1])
Myalgia
Code List
Constitutional: Myalgia. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Myalgia Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Constitutional: Fatigue. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0015672 (UMLS CUI [1])
Fatigue
Code List
Constitutional: Fatigue. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Fatigue Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Respiratory: Cough. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0010200 (UMLS CUI [1])
Cough
Code List
Respiratory: Cough. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Cough Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Respiratory: Pharyngitis. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0031350 (UMLS CUI [1])
Pharyngitis
Code List
Respiratory: Pharyngitis. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Pharyngitis maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Item
Respiratory: Dyspnea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
text
C0013404 (UMLS CUI [1])
Dyspnea
Code List
Respiratory: Dyspnea. Is Symptom Associated with this Abacavir Hypersensitivity Reaction?
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])
Fever Maximum Toxicity
Code List
Dyspnea Maximum Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or 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])
drug allergy
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])
Fever Maximum Toxicity
Code List
Other Symptoms, Max Toxicity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator’s signature date
Item
Investigator’s signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator’s name
Item
Investigator’s name (print)
text
C2346576 (UMLS CUI [1])
Item
Since the previous scheduled study visit, did the subject use any of the health care services listed below due to HIV-associated conditions, adverse events, or serious adverse events including HSR.
text
C0086388 (UMLS CUI [1])
drug allergy
Code List
Since the previous scheduled study visit, did the subject use any of the health care services listed below due to HIV-associated conditions, adverse events, or serious adverse events including HSR.
CL Item
Yes (Y)
CL Item
No (N)
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