Genetic Screening For HLA-B*5701 Day 1 NCT00340080

Day 1 (Baseline)
Description

Day 1 (Baseline)

Alias
UMLS CUI-1
C1516637
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
Did subject meet all the entry criteria?
Description

If No, 􏰀check all boxes corresponding to violations of any inclusion/exclusion criteria. Do not start ABC-Containing product and withdraw the subject from the study.

Data type

text

Alias
UMLS CUI [1]
C1516637
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
Description

Exclusion Criteria

Data type

integer

Alias
UMLS CUI [1]
C0680251
Has the subject previously received and permanently stopped antiretroviral therapy prior to ABC-containing product initiation?
Description

If Yes, record each medication on a separate line using Trade Names where possible.

Data type

text

Alias
UMLS CUI [1]
C1963724
Drug Name (Trade name preferred)
Description

If Yes, record each medication on a separate line using Trade Names where possible.

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C1963724
Start Date
Description

If Yes, record each medication on a separate line using Trade Names where possible.

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1963724
Stop Date
Description

If Yes, record each medication on a separate line using Trade Names where possible.

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1963724
Ongoing Medication?
Description

If Yes, record each medication on a separate line using Trade Names where possible.

Data type

text

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1963724
Medical Conditions
Description

(previous form)

Data type

text

Alias
UMLS CUI [1]
C0012634
Record the subject’s Baseline CDC classification below, check 􏰀one in Category A, B, or C
Description

CDC classification

Data type

integer

Alias
UMLS CUI [1]
C2319244
Vital signs: Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

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

Blood pressure diastolic

Data type

integer

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

Heart rate

Data type

integer

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

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Date sample taken
Description

Complete for Female Subjects Only

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test results
Description

Pregnancy test results

Data type

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040

Similar models

Genetic Screening For HLA-B*5701 Day 1 NCT00340080

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Day 1 (Baseline)
C1516637 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Did subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Code List
Did subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
integer
C0680251 (UMLS CUI [1])
Code List
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
Did not meet treatment eligibility criteria (14)
CL Item
The investigational site does not receive written notification that it is appropriate to initiate ABC- containing HAART as part of this study. (15)
Item
Has the subject previously received and permanently stopped antiretroviral therapy prior to ABC-containing product initiation?
text
C1963724 (UMLS CUI [1])
Code List
Has the subject previously received and permanently stopped antiretroviral therapy prior to ABC-containing product initiation?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name (Trade name preferred)
text
C2360065 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Medical Conditions
Item
Medical Conditions
text
C0012634 (UMLS CUI [1])
Item
Record the subject’s Baseline CDC classification below, check 􏰀one in Category A, B, or C
integer
C2319244 (UMLS CUI [1])
Code List
Record the subject’s Baseline CDC classification below, check 􏰀one in Category A, B, or C
CL Item
Category A: Asymptomatic HIV infection/Persistent generalized lymphadenopathy/Acute (primary) HIV infection with accompanying illness or history of acute HIV (1)
CL Item
Category B: Symptomatic (non-AIDS) conditions (2)
CL Item
Category C: AIDS Indicator Conditions as defined by diagnostic or presumptive measures (3)
Blood pressure systolic
Item
Vital signs: Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Vital signs: Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Vital signs: Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Vital signs: Temperature
float
C0005903 (UMLS CUI [1])
Pregnancy test date
Item
Date sample taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test results
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Pregnancy test results
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)