ID

21156

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: LOGs 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. 12.04.17 12.04.17 -
Hochgeladen am

12. April 2017

DOI

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Lizenz

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

Englisch

HLA-B*5701 And Hypersensitivity To Abacavir LOGs NCT00373945

1 Formulare  
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

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

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Non Serious Adverse Event
Beschreibung

Non Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Sequence Number
Beschreibung

Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1518404
Event Diagnosis only (if known) otherwise Sign/Symptom
Beschreibung

Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C1518404
Modified term
Beschreibung

Modified term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
UMLS CUI [2]
C1518404
MedDRA synonym
Beschreibung

MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0871468
UMLS CUI [1,2]
C1518404
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C1518404
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
End Date
Beschreibung

If Recovered/Resolved, provide End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
End Date
Beschreibung

If Recovered/Resolved with sequelae, provide End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Toxicity or Intensity
Beschreibung

Maximum Toxicity or Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
UMLS CUI [2]
C1518404
Action taken with exposure to topical abacavir as a result of the AE
Beschreibung

Action taken with exposure to topical abacavir as a result of the AE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C0663655
UMLS CUI [2]
C1518404
Action taken with IP as a Result of the AE
Beschreibung

Action taken with IP as a Result of the AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by topical abacavir?
Beschreibung

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

Datentyp

text

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0663655
UMLS CUI [2]
C1518404
Duration of AE if < 24 hours
Beschreibung

xx Hr(s) ( 0=<n<=23 ) xx Min(s) (0=<n<=59 )

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Beschreibung

xx Hr(s) ( 0=<n<=23 ) xx Min(s) (0=<n<=59 )

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
Serious Adverse Events
Beschreibung

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Type of report
Beschreibung

Type of report

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C1519255
Did SAE occur after application of topical abacavir?
Beschreibung

Did SAE occur after application of topical abacavir?

Datentyp

text

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0663655
UMLS CUI [1,3]
C0185125
UMLS CUI [2]
C1519255
SAE Sequence Number
Beschreibung

SAE Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event Diagnosis only (if known) otherwise Sign/Symptom
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0011900
Modified term
Beschreibung

Modified term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
UMLS CUI [2]
C1519255
MedDRA synonym
Beschreibung

MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
UMLS CUI [2]
C1519255
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1519255
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
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]
C1705586
End Date
Beschreibung

If Recovered/Resolved, provide End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End Date
Beschreibung

If Recovered/Resolved with sequelae, provide End Date

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]
C0439793
UMLS CUI [1,2]
C1519255
Action taken with exposure to topical abacavir as a result of the AE
Beschreibung

Action taken with exposure to topical abacavir as a result of the AE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C0663655
UMLS CUI [2]
C1519255
Action taken with Investigational Products as a Result of the AE
Beschreibung

Action taken with IP as a Result of the AE

Datentyp

text

Alias
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by topical abacavir?
Beschreibung

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

Datentyp

text

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0663655
UMLS CUI [1,3]
C1519255
Duration of AE if < 24 hours
Beschreibung

xx Hr(s) ( 0=<n<=23 ) xx Min(s) (0=<n<=59 )

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
Time to Onset Since Last Dose
Beschreibung

xx Hr(s) ( 0=<n<=23 ) xx Min(s) (0=<n<=59 )

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1519255
Was SAE caused by activities related to study participation (e.g. procedures?)
Beschreibung

Was SAE caused by activities related to study participation (e.g. procedures?)

Datentyp

text

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C1519255
Was the event serious?
Beschreibung

Was the event serious?

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Seriousness
Beschreibung

Specify the reason for considering this an SAE. Check all that apply

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C1519255
CM Sequence Number
Beschreibung

Include details of any medication that may have contributed to the SAE or was used to treat the SAE.

Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

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

Dose

Datentyp

float

Alias
UMLS CUI [1,1]
C3174092
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

integer

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

Route

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013153
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
Ongoing?
Beschreibung

Ongoing?

Datentyp

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
End Date
Beschreibung

If not ongoing please specify End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Primary Indication
Beschreibung

Primary Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Drug Type
Beschreibung

Drug Type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C2347852
UMLS CUI [2]
C1519255
MHx Sequence Number
Beschreibung

Specify past or current medical disorders, allergies, surgeries family or social history that may help explain the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Specific Condition Name
Beschreibung

Specific Condition Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Continuing?
Beschreibung

Continuing?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Date of last occurrence
Beschreibung

Please specify if "Continuing"=No

Datentyp

date

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C1519255
Relevant Medical History / Risk Factors not noted above
Beschreibung

Relevant Medical History / Risk Factors

Datentyp

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C1519255
Lab Sequence Number
Beschreibung

Provide details of any tests or procedures carried out to diagnose the SAE

Datentyp

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C1519255
Test Name
Beschreibung

Test Name

Datentyp

text

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C1519255
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
UMLS CUI [2]
C1519255
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C1519255
Test Units
Beschreibung

Test Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0022885
UMLS CUI [2]
C1519255
Normal Low Range
Beschreibung

Normal Low Range

Datentyp

text

Alias
UMLS CUI [1,1]
C1514721
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0205251
UMLS CUI [2]
C0022885
Normal High Range
Beschreibung

High

Datentyp

text

Alias
UMLS CUI [1,1]
C1514721
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0205250
UMLS CUI [2]
C0022885
Relevant diagnostic results not notes above
Beschreibung

Relevant diagnostic results not notes above

Datentyp

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0086143
UMLS CUI [1,3]
C0243095
UMLS CUI [2]
C1519255
If patch was removed, did the reported event recur after patch was reapplied?
Beschreibung

If patch was removed, did the reported event recur after patch was reapplied?

Datentyp

text

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0030646
UMLS CUI [2]
C1519255
General narrative comments
Beschreibung

Provide a brief description of SAE, possible cause of the event (e.g., the disease under study or other medical conditions) and details of the treatment.

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
General narrative comments
Beschreibung

Provide a brief description of SAE, possible cause of the event (e.g., the disease under study or other medical conditions) and details of the treatment.

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Concomitant Antiretroviral Therapy
Beschreibung

Concomitant Antiretroviral Therapy

Alias
UMLS CUI-1
C1963724
UMLS CUI-2
C2347852
Sequence Number
Beschreibung

Concomitant Antiretroviral Therapy, within two weeks prior to baseline and through study completion

Datentyp

text

Alias
UMLS CUI [1]
C2348184
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
GSK Drug synonym
Beschreibung

GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
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 [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1963724
UMLS CUI [1,3]
C2347852
Taken Prior to Study
Beschreibung

Taken Prior to Study

Datentyp

text

Alias
UMLS CUI [1,1]
C2826667
UMLS CUI [1,2]
C1963724
Ongoing?
Beschreibung

Ongoing?

Datentyp

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1963724
UMLS CUI [1,3]
C2347852
End Date
Beschreibung

If not ongoing please specify End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1963724
UMLS CUI [1,3]
C2347852
Medication Type
Beschreibung

Medication Type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C2347852
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschreibung

Concomitant Medications within two weeks prior to baseline and through study completion

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
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C2347852
Route
Beschreibung

Route

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
UMLS CUI [2]
C2347852
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Taken Prior to Study?
Beschreibung

Taken Prior to Study

Datentyp

text

Alias
UMLS CUI [1]
C2826667
UMLS CUI [2]
C2347852
Ongoing?
Beschreibung

Ongoing?

Datentyp

text

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

If not ongoing please specify End Date

Datentyp

date

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

Medication Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C2347852
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HLA-B*5701 And Hypersensitivity To Abacavir LOGs NCT00373945

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Item Group
Non Serious Adverse Event
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Event
Item
Event Diagnosis only (if known) otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
MedDRA synonym
Item
MedDRA synonym
text
C0871468 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Toxicity or Intensity
integer
C1710066 (UMLS CUI [1])
C1518404 (UMLS CUI [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 exposure to topical abacavir as a result of the AE
integer
C0441472 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Action taken with exposure to topical abacavir as a result of the AE
Code List
Action taken with exposure to topical abacavir as a result of the AE
CL Item
Patch removed permanently (1)
CL Item
No action taken (2)
CL Item
Not applicable (3)
Action taken with IP as a Result of the AE
Item
Action taken with IP as a Result of the AE
text
C0441472 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this AE?
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by topical abacavir?
text
C1510821 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Did the subject withdraw from study as a result of this AE?
Code List
Is there a reasonable possibility that the AE may have been caused by topical abacavir?
CL Item
Yes (Y)
CL Item
No (N)
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Item
Type of report
integer
C2348792 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Type of report
Code List
Type of report
CL Item
Initial (1)
CL Item
Follow-Up (2)
Item
Did SAE occur after application of topical abacavir?
text
C1510821 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C0185125 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Did the subject withdraw from study as a result of this AE?
Code List
Did SAE occur after application of topical abacavir?
CL Item
Yes (Y)
CL Item
No (N)
SAE Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis only (if known) otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
MedDRA synonym
Item
MedDRA synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Toxicity or Intensity
integer
C0439793 (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 exposure to topical abacavir as a result of the AE
integer
C0441472 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Action taken with exposure to topical abacavir as a result of the AE
Code List
Action taken with exposure to topical abacavir as a result of the AE
CL Item
Patch removed permanently (1)
CL Item
No action taken (2)
CL Item
Not applicable (3)
Action taken with IP as a Result of the AE
Item
Action taken with Investigational Products as a Result of the AE
text
C0441472 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this AE?
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by topical abacavir?
text
C1510821 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Code List
Is there a reasonable possibility that the AE may have been caused by topical abacavir?
CL Item
Yes (Y)
CL Item
No (N)
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Was SAE caused by activities related to study participation (e.g. procedures?)
text
C1510821 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this AE?
Code List
Was SAE caused by activities related to study participation (e.g. procedures?)
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the event serious?
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this AE?
Code List
Was the event serious?
CL Item
Yes (Y)
CL Item
No (N)
Item
Seriousness
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Seriousness
Code List
Seriousness
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 within general narrative comment (F)
CM Sequence Number
Item
CM Sequence Number
text
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Dose
Item
Dose
float
C3174092 (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
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 [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (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)
Item
Route
integer
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Route
Code List
Route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-aterial (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Vaginal (24)
CL Item
Unknown (25)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Ongoing?
text
C0549178 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Did the subject withdraw from study as a result of this AE?
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Primary Indication
Item
Primary Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Drug Type
integer
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Drug Type
Code List
Drug Type
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
MHx Sequence Number
Item
MHx Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Date of Onset
Item
Date of Onset
date
C0808070 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Continuing?
integer
C0549178 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Continuing?
Code List
Continuing?
CL Item
Yes (1)
CL Item
No, specify date of last occurrence (2)
CL Item
Unknown (3)
Date of last occurrence
Item
Date of last occurrence
date
C0262926 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Relevant Medical History / Risk Factors
Item
Relevant Medical History / Risk Factors not noted above
text
C0262926 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Lab Sequence Number
Item
Lab Sequence Number
text
C0262926 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Test Name
Item
Test Name
text
C0022885 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Test Date
Item
Test Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Normal Low Range
Item
Normal Low Range
text
C1514721 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0022885 (UMLS CUI [2])
High
Item
Normal High Range
text
C1514721 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C0022885 (UMLS CUI [2])
Relevant diagnostic results not notes above
Item
Relevant diagnostic results not notes above
text
C0587081 (UMLS CUI [1,1])
C0086143 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Item
If patch was removed, did the reported event recur after patch was reapplied?
text
C1510821 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
If patch was removed, did the reported event recur after patch was reapplied?
Code List
If patch was removed, did the reported event recur after patch was reapplied?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
General narrative comments
Item
General narrative comments
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
General narrative comments
Item
General narrative comments
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Concomitant Antiretroviral Therapy
C1963724 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
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])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Item
Units
text
C1519795 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Unit
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
text
C3476109 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
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 [1,1])
C1963724 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Item
Taken Prior to Study
text
C2826667 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this AE?
Code List
Taken Prior to Study
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C0549178 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Item
Medication Type
integer
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Medication Type
Code List
Medication Type
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Concomitant Medications
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])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Item
Route
integer
C0013153 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Route
Code List
Route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-aterial (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Vaginal (24)
CL Item
Unknown (25)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Did the subject withdraw from study as a result of this AE?
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C0549178 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Did the subject withdraw from study as a result of this AE?
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Medication Type
Code List
Medication Type
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
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