Informatie:
Fout:
ID
21393
Beschrijving
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
Trefwoorden
Versies (1)
- 19/04/2017 19/04/2017 -
Geüploaded op
19 avril 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Genetic Screening For HLA-B*5701 in Patients with HIV Abacavir Hypersensitivity Reaction Record NCT00340080
Genetic Screening For HLA-B*5701 Abacavir Hypersensitivity Reaction Record NCT00340080
Similar models
Genetic Screening For HLA-B*5701 Abacavir Hypersensitivity Reaction Record NCT00340080
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Abacavir Hypersensitivity Reaction Record
C0020517 (UMLS CUI-1)
C0663655 (UMLS CUI-2)
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])
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])
C0020517 (UMLS CUI [1,2])
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])
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])
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])
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)
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])
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])
C0013182 (UMLS CUI [1,2])
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)
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)
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)
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])
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])
C2348235 (UMLS CUI [1,2])
CL Item
local (1)
CL Item
disseminated (2)
Item
Nature of cutaneous findings, check 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)
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])
C0808070 (UMLS CUI [1,2])
Item
Fever Maximum Toxicity or Intnsity
integer
C0015967 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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])
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
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])
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
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])
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])
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)