ID

21510

Beschreibung

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: Serious Adverse Events Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Stichworte

Versionen (1)
  1. 25.04.17 25.04.17 -
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25. April 2017

DOI

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Genetic Screening For HLA-B*5701 in Patients with HIV Serious Adverse Events NCT00340080

Englisch

Genetic Screening For HLA-B*5701 Serious Adverse Events NCT00340080

1 Formulare  
Serious Adverse Events
Beschreibung

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Did the subject experience a serious adverse event during the study?
Beschreibung

Serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Event, Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

If Yes, record details below.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date
Beschreibung

If fatal, record date of death

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Maximum Toxicity or Intensity
Beschreibung

Maximum Toxicity or Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschreibung

Action Taken with Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C1704758
UMLS CUI [2]
C1519255
Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdrawal

Datentyp

text

Alias
UMLS CUI [1]
C1710677
UMLS CUI [2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

Relationship to Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1]
C3828190
If fatal, was a post-mortem/autopsy performed
Beschreibung

If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.

Datentyp

text

Alias
UMLS CUI [1]
C0004398
Specify reason(s) for considering this a SAE, 􏰀check all that apply
Beschreibung

Seriousness

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Seriousness reason: Other, specify
Beschreibung

Seriousness reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

reported adverse event recur

Datentyp

text

Alias
UMLS CUI [1]
C3828190
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
UMLS CUI [2]
C1519255
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1519255
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1519255
kg
Possible Causes of SAE Other Than Investigational Product(s), check 􏰀all that apply:
Beschreibung

Possible Causes of SAE

Datentyp

text

Alias
UMLS CUI [1]
C3828190
UMLS CUI [2]
C1519255
Possible Causes of SAE: Other, specify
Beschreibung

Possible Causes of SAE

Datentyp

text

Alias
UMLS CUI [1]
C3828190
UMLS CUI [2]
C1519255
Date of Onset
Beschreibung

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE

Datentyp

date

Alias
UMLS CUI [1]
C0574845
UMLS CUI [2]
C1519255
Condition present at Time of the SAE?
Beschreibung

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C3827351
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Beschreibung

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C1519255
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Beschreibung

Risk Factors

Datentyp

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C1519255
Drug Name (Trade Name preferred)
Beschreibung

RELEVANT Concomitant Medications (include details of any concomitant medication(s) which may have contributed to the event)

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Stop Date
Beschreibung

Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Ongoing Medication?
Beschreibung

Ongoing Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826666
UMLS CUI [2]
C1519255
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Taken Prior to Study?
Beschreibung

Taken Prior to Study

Datentyp

text

Alias
UMLS CUI [1,1]
C2826667
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2347852
UMLS CUI [2]
C1519255
Investigational Product Ziagen: Dose
Beschreibung

Note: Investigational Product(s) = ABC-Containing Products Details of Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0724476
UMLS CUI [2]
C1519255
Investigational Product Ziagen: Units
Beschreibung

Ziagen Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0724476
UMLS CUI [2]
C1519255
Investigational Product Ziagen: Frequency
Beschreibung

Ziagen Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C0724476
UMLS CUI [2]
C1519255
Investigational Product Ziagen: Start Date
Beschreibung

Ziagen Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0724476
UMLS CUI [2]
C1519255
Investigational Product Ziagen: Stop Date
Beschreibung

Ziagen Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0724476
UMLS CUI [2]
C1519255
Investigational Product Trizivir: Dose
Beschreibung

Note: Investigational Product(s) = ABC-Containing Products Details of Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0939514
UMLS CUI [2]
C1519255
Investigational Product Trizivir: Units
Beschreibung

Trizivir Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0939514
UMLS CUI [2]
C1519255
Investigational Product Trizivir: Frequency
Beschreibung

Trizivir Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C0939514
UMLS CUI [2]
C1519255
Investigational Product Trizivir: Start Date
Beschreibung

Trizivir Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0939514
UMLS CUI [2]
C1519255
Investigational Product Trizivir: Stop Date
Beschreibung

Trizivir Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0939514
UMLS CUI [2]
C1519255
Investigational Product Kivexa: Dose
Beschreibung

Note: Investigational Product(s) = ABC-Containing Products Details of Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1567988
UMLS CUI [2]
C1519255
Investigational Product Kivexa: Units
Beschreibung

Kivexa Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C1567988
UMLS CUI [2]
C1519255
Investigational Product Kivexa: Frequency
Beschreibung

Kivexa Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C1567988
UMLS CUI [2]
C1519255
Investigational Product Kivexa: Start Date
Beschreibung

Kivexa Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1567988
UMLS CUI [2]
C1519255
Investigational Product Kivexa: Stop Date
Beschreibung

Kivexa Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1567988
UMLS CUI [2]
C1519255
Investigational Product Abacavir Patch Test: Start Date
Beschreibung

Note: Investigational Product(s) = ABC-Containing Products Details of Investigational Product(s)

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0663655
UMLS CUI [1,3]
C0030646
UMLS CUI [2]
C1519255
Investigational Product Abacavir Patch Test: Stop Date
Beschreibung

Abacavir Patch Test Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0663655
UMLS CUI [1,3]
C0030646
UMLS CUI [2]
C1519255
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
Beschreibung

Details of relevant Assessments

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1522508
UMLS CUI [2]
C1519255
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beschreibung

Narrative Remarks

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator’s signature
Beschreibung

(confirming that the data on the SAE pages are accurate and complete)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator’s signature Date
Beschreibung

Investigator’s signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Genetic Screening For HLA-B*5701 Serious Adverse Events NCT00340080

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
non-serious adverse events
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Serious adverse event
Item
Event, Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Toxicity or Intensity
integer
C1710066 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Toxicity or Intensity
Code List
Maximum Toxicity or Intensity
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)
CL Item
Not applicable (5)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational products withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Item
Did the subject withdraw from study as a result of this AE?
text
C1710677 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
non-serious adverse events
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C3828190 (UMLS CUI [1])
non-serious adverse events
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Item
If fatal, was a post-mortem/autopsy performed
text
C0004398 (UMLS CUI [1])
non-serious adverse events
Code List
If fatal, was a post-mortem/autopsy performed
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Item
Specify reason(s) for considering this a SAE, 􏰀check all that apply
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Specify reason(s) for considering this a SAE, 􏰀check all that apply
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
CL Item
Hypersensitivity reactions to abacavir. (G)
Seriousness reason
Item
Seriousness reason: Other, specify
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C3828190 (UMLS CUI [1])
non-serious adverse events
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item
Sex
text
C0079399 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item
Possible Causes of SAE Other Than Investigational Product(s), check 􏰀all that apply:
text
C3828190 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
undefined item
Code List
Possible Causes of SAE Other Than Investigational Product(s), check 􏰀all that apply:
CL Item
Disease under study (1)
CL Item
Medical condition(s), specify (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s), specify (record in Section 8) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Possible Causes of SAE
Item
Possible Causes of SAE: Other, specify
text
C3828190 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item
Condition present at Time of the SAE?
text
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Condition present at Time of the SAE
Code List
Condition present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Risk Factors
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Drug Name
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Unit
Code List
Unit
CL Item
Tablet  (TAB)
CL Item
Microlitre  (MCL)
CL Item
Millilitre  (ML)
CL Item
Litre  (L)
CL Item
Microgram  (MCG)
CL Item
Milligram  (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Frequency
Code List
Frequency
CL Item
1 x Daily (OD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily  (QID)
CL Item
As required (PRN)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
non-serious adverse events
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (A)
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Condition present at Time of the SAE
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Ziagen Dose
Item
Investigational Product Ziagen: Dose
text
C3174092 (UMLS CUI [1,1])
C0724476 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Ziagen Units
Item
Investigational Product Ziagen: Units
text
C1519795 (UMLS CUI [1,1])
C0724476 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Ziagen Frequency
Item
Investigational Product Ziagen: Frequency
text
C3476109 (UMLS CUI [1,1])
C0724476 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Ziagen Start Date
Item
Investigational Product Ziagen: Start Date
date
C0808070 (UMLS CUI [1,1])
C0724476 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Ziagen Stop Date
Item
Investigational Product Ziagen: Stop Date
date
C0806020 (UMLS CUI [1,1])
C0724476 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Trizivir Dose
Item
Investigational Product Trizivir: Dose
text
C3174092 (UMLS CUI [1,1])
C0939514 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Trizivir Units
Item
Investigational Product Trizivir: Units
text
C1519795 (UMLS CUI [1,1])
C0939514 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Trizivir Frequency
Item
Investigational Product Trizivir: Frequency
text
C3476109 (UMLS CUI [1,1])
C0939514 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Trizivir Start Date
Item
Investigational Product Trizivir: Start Date
date
C0808070 (UMLS CUI [1,1])
C0939514 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Trizivir Stop Date
Item
Investigational Product Trizivir: Stop Date
date
C0806020 (UMLS CUI [1,1])
C0939514 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Kivexa Dose
Item
Investigational Product Kivexa: Dose
text
C3174092 (UMLS CUI [1,1])
C1567988 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Kivexa Units
Item
Investigational Product Kivexa: Units
text
C1519795 (UMLS CUI [1,1])
C1567988 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Kivexa Frequency
Item
Investigational Product Kivexa: Frequency
text
C3476109 (UMLS CUI [1,1])
C1567988 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Kivexa Start Date
Item
Investigational Product Kivexa: Start Date
date
C0808070 (UMLS CUI [1,1])
C1567988 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Kivexa Stop Date
Item
Investigational Product Kivexa: Stop Date
date
C0806020 (UMLS CUI [1,1])
C1567988 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Abacavir Patch Test Start Date
Item
Investigational Product Abacavir Patch Test: Start Date
date
C0808070 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C0030646 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Abacavir Patch Test Stop Date
Item
Investigational Product Abacavir Patch Test: Stop Date
date
C0806020 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C0030646 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Details of relevant Assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C1261322 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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])
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