ID

30780

Beschreibung

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Stichworte

Versionen (1)
  1. 20.06.18 20.06.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Juni 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

Deutsch Englisch

LOG Visit

1 Formulare  
  1. StudyEvent: ODM
    1. LOG Visit
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
AE status
Beschreibung

AE status

Alias
UMLS CUI-1
C0877248
Did the subject experience any non-serious adverse events during the study?
Beschreibung

non-serious adverse events

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Log status
Beschreibung

Log status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
4. Did the subject experience any serious adverse events during the study?
Beschreibung

serious adverse events

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
5. Were any Non-Diary concomitant medications taken by the subject prior to screening and/or during the study?
Beschreibung

concomitant medications

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence number
Beschreibung

Sequence number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Drug name (Trade name preferred)
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
UMLS CUI [2]
C2347852
Unit Dose
Beschreibung

Unit Dose

Datentyp

float

Alias
UMLS CUI [1]
C0869039
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Generic Dispensed?
Beschreibung

Generic Dispensed

Datentyp

boolean

Alias
UMLS CUI [1]
C3242750
Prescription or OTC?
Beschreibung

Prescription or OTC

Datentyp

text

Alias
UMLS CUI [1]
C3166216
UMLS CUI [2]
C0013231
Stat Date
Beschreibung

Medication start datetime

Datentyp

datetime

Alias
UMLS CUI [1]
C3173309
Taken Prior to Study?
Beschreibung

Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Ongoing
Beschreibung

If No, specify End Date

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Concomitant Medication: End Date
Beschreibung

Concomitant Medication: End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Device used to administer medication
Beschreibung

Device used to administer medication

Datentyp

text

Alias
UMLS CUI [1]
C0699733
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

integer

Alias
UMLS CUI [1]
C2348070
Was drug administered for an exacerbation?
Beschreibung

drug adminstered for an exacerbation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C4086268
Was drug administered as a rescue medication?
Beschreibung

Rescue Medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
Cumulative Dose used?
Beschreibung

Total Dose

Datentyp

integer

Alias
UMLS CUI [1]
C2986497
Was drug ever used
Beschreibung

drug use

Datentyp

boolean

Alias
UMLS CUI [1]
C0242510
Total duration
Beschreibung

Total duration

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0449238
Duration unit
Beschreibung

duration

Datentyp

text

Alias
UMLS CUI [1]
C0449238
Non-serious adverse event
Beschreibung

Non-serious adverse event

Sequence Number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Modified term
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
Start Date
Beschreibung

Condition item Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
End date
Beschreibung

If outcome "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date.

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beschreibung

Record maximum intensity throughout duration of event. Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Intensity at onset of event
Beschreibung

Record intensity at the onset of the event [hidden]. Conditional item: Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used.

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Maximum Grade
Beschreibung

Record maximum grade throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1]
C0441799
Grade at onset of event
Beschreibung

Conditional item Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional

Datentyp

integer

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0441799
Maximum Grade or Intensity
Beschreibung

Record maximum grade or intensity throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

Datentyp

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Grade or Intensity at onset of event
Beschreibung

Record grade or intensity at the onset of the event [hidden]. Conditional item Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken with Investigational Product

Datentyp

text

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

Withdrawal from study

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Use best judgment at initial entry. May be amended when additional information becomes available. If the study has multiple IP then remove Yes and keep Yes, select appropriate investigational product(s)' and set selection value to Y. Otherwise remove Yes, select appropriate investigational product(s) and keep Yes.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
Duration of AE if < 24 hours (hours)
Beschreibung

If AE start and end time are used this item must be hidden.

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
h
Duration of AE if < 24 hours (minutes)
Beschreibung

If AE start and end time are used this item must be hidden.

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
min
Time to Onset Since Last Dose (hours)
Beschreibung

[hidden] This item is optional

Datentyp

integer

Maßeinheiten
  • h
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
h
Time to Onset Since Last Dose (minutes)
Beschreibung

[hidden] This item is optional

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min
Report
Beschreibung

Report

Initial report
Beschreibung

Initial report

Datentyp

boolean

Alias
UMLS CUI [1]
C0684224
Follow-up report
Beschreibung

Follow-up report

Datentyp

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Beschreibung

SAE after initiation of study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1519255
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Beschreibung

Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Modified term
Beschreibung

Modified term

Datentyp

text

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

MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C1519255
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C1519255
Did the subject experience a serious adverse event during the study?
Beschreibung

serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Did SAE occur after initiation of study medication?
Beschreibung

Did SAE occur after initiation of study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start Date
Beschreibung

Serious Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Start Time Serious Adverse Event
Beschreibung

Start Time Serious Adverse Event

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697889
Serious Adverse Event End Date
Beschreibung

Serious Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697886
Serious Adverse Event End Time
Beschreibung

Serious Adverse Event End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826658
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
Date of Death
Beschreibung

Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Maximum Intensity
Beschreibung

Intensity (maximum)

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Intensity at onset of event
Beschreibung

Intensity at onset of event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Maximum Grade
Beschreibung

Record maximum grade throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1]
C0441799
Grade at onset of event
Beschreibung

Record grade at the onset of the event [hidden]. Conditional item Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional

Datentyp

integer

Alias
UMLS CUI [1]
C2985911
Maximum Grade or Intensity
Beschreibung

Record maximum grade or intensity throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.

Datentyp

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Grade or Intensity at onset of event
Beschreibung

Record grade or intensity at the onset of the event [hidden]. Conditional item Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action Taken with Respect to Investigational Drug
Beschreibung

Action Taken

Datentyp

integer

Alias
UMLS CUI [1]
C1547656
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
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

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Duration of AE if < 24 hours
Beschreibung

Duration of AE if < 24 hours

Datentyp

integer

Maßeinheiten
  • Hr(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Hr(s)
Time to Onset Since Last Dose
Beschreibung

Time to Onset Since Last Dose

Datentyp

integer

Maßeinheiten
  • Min(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0449244
Min(s)
Was SAE caused by activities related to study participation (e.g.procedures)?
Beschreibung

SAE Causation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
Was the event serious?
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Related investigational product
Beschreibung

investigational product

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Intensity changes
Beschreibung

Intensity changes

Serious Adverse Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Start Date of event segment
Beschreibung

If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Start Time of event segment Hr:Min (00:00-23:59)
Beschreibung

If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.

Datentyp

time

Alias
UMLS CUI [1]
C2697889
Intensity of event segment
Beschreibung

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Grade of event segment
Beschreibung

Optional item: This item may be hidden if either the Intensity of event segment or Grade or intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1]
C2985911
Grade or Intensity of event segment
Beschreibung

Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section. Grade 5 is optional.

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C0871902
UMLS CUI-2
C1519255
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
Beschreibung

Seriousness

Datentyp

integer

Alias
UMLS CUI [1]
C1710056
Seriousness: If other, specify:
Beschreibung

Seriousness Other

Datentyp

text

Alias
UMLS CUI [1]
C1710056
Relevant concomitant / treatment medications
Beschreibung

Relevant concomitant / treatment medications

CM Sequence Number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Drug name
Beschreibung

Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Dose
Beschreibung

Dose

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

units of medication

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route of medication

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Ongoing?
Beschreibung

Ongoing medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
If no ongoing medication, specify end date
Beschreibung

End date medication

Datentyp

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Primary Indication
Beschreibung

Enter a medical diagnosis not description

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Modified reported term
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Drug Type
Beschreibung

Drug Type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Relevant diagnostic results
Beschreibung

Relevant diagnostic results

Lab Sequence Number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Test Name
Beschreibung

Only allow site to choose from List of Values.

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0456984
Test Units
Beschreibung

Test Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Beschreibung

Normal Low Range

Datentyp

text

Alias
UMLS CUI [1]
C2700150
Normal High Range
Beschreibung

Normal High Range

Datentyp

text

Alias
UMLS CUI [1]
C2700149
Relevant diagnostic results not noted above
Beschreibung

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Beschreibung

Rechallenge

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
INVESTIGATIONAL PRODUCT
Beschreibung

INVESTIGATIONAL PRODUCT

Alias
UMLS CUI-1
C0304229
Study drug
Beschreibung

Study drug

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Start Date
Beschreibung

start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

stop date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Regimen
Beschreibung

Regimen

Datentyp

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0013227
General narrative comments
Beschreibung

General narrative comments

General narrative comments
Beschreibung

Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, 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
Non clinical
Beschreibung

Non clinical

22. [3] Incomplete SAE
Beschreibung

Send incomplete SAE data to GSK Safety [hidden]. This item is optional

Datentyp

boolean

Alias
UMLS CUI [1]
C1710056
23. Receipt by GSK date
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1]
C2985846
23. Receipt by GSK date
Beschreibung

[hidden]

Datentyp

date

Alias
UMLS CUI [1]
C2985846
24. Was the event serious?
Beschreibung

[hidden]

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
25. SAE Sequence Number
Beschreibung

[read-only]

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
26. Version Number
Beschreibung

[hidden]

Datentyp

integer

Alias
UMLS CUI [1]
C2985700
27. Case ID
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
28. Randomisation Number
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
29. OCEANS Code
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1516728
Email Flag
Beschreibung

[hidden]

Datentyp

text

Alias
UMLS CUI [1]
C0013849
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Ähnliche Modelle

LOG Visit

1 Formulare
  1. StudyEvent: ODM
    1. LOG Visit
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
AE status
C0877248 (UMLS CUI-1)
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Item Group
Log status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
serious adverse events
Item
4. Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
concomitant medications
Item
5. Were any Non-Diary concomitant medications taken by the subject prior to screening and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Sequence number
Item
Sequence number
integer
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Generic Dispensed
Item
Generic Dispensed?
boolean
C3242750 (UMLS CUI [1])
Item
Prescription or OTC?
text
C3166216 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
Prescription or OTC
Code List
Prescription or OTC?
CL Item
Prescription (1)
CL Item
OTC (2)
Medication start datetime
Item
Stat Date
datetime
C3173309 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
medication ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication End Date
Item
Concomitant Medication: End Date
date
C2826744 (UMLS CUI [1])
Device used to administer medication
Item
Device used to administer medication
text
C0699733 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1])
drug adminstered for an exacerbation
Item
Was drug administered for an exacerbation?
boolean
C3469597 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
Rescue Medication
Item
Was drug administered as a rescue medication?
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Total Dose
Item
Cumulative Dose used?
integer
C2986497 (UMLS CUI [1])
drug use
Item
Was drug ever used
boolean
C0242510 (UMLS CUI [1])
Total duration
Item
Total duration
integer
C2347852 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
duration
Item
Duration unit
text
C0449238 (UMLS CUI [1])
Item Group
Non-serious adverse event
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Non-serious adverse event
Item
Event
text
C1518404 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome / End Date
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
C1709862 (UMLS CUI-1)
(Comment:en)
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
Intensity at onset of event
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Intensity at onset of event
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
Maximum Grade
integer
C0441799 (UMLS CUI [1])
Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (1)
C0687695 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 2 (2)
C1522446 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 3 (3)
C0450094 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 4 (4)
C0547054 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 5 (5)
C2985911 (UMLS CUI-1)
(Comment:en)
Item
Grade at onset of event
integer
C2985916 (UMLS CUI [1,1])
C0441799 (UMLS CUI [1,2])
Maximum Grade
Code List
Grade at onset of event
CL Item
Grade 1 (1)
C0687695 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 2 (2)
C1522446 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 3 (3)
C0450094 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 4 (4)
C0547054 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 5 (5)
C2985911 (UMLS CUI-1)
(Comment:en)
Item
Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade or Intensity
Code List
Maximum Grade 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
Grade 5 (5)
CL Item
Not applicable (X)
Item
Grade or Intensity at onset of event
text
C1710066 (UMLS CUI [1])
Maximum Grade or Intensity
Code List
Grade or Intensity at onset of event
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
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
C0304229 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Withdrawal from study
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
AE caused by investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE hours
Item
Duration of AE if < 24 hours (hours)
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of AE minutes
Item
Duration of AE if < 24 hours (minutes)
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose hours
Item
Time to Onset Since Last Dose (hours)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Time to Onset Since Last Dose minutes
Item
Time to Onset Since Last Dose (minutes)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
Report
Initial report
Item
Initial report
boolean
C0684224 (UMLS CUI [1])
Follow-up report
Item
Follow-up report
boolean
C1704685 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
SAE after initiation of study medication
Item
Did SAE occur after initiation of study medication?
boolean
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Did SAE occur after initiation of study medication
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
Start Time Serious Adverse Event
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (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, record Date of Death  (5)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Maximum Intensity
CL Item
Mild (1)
(Comment:en)
CL Item
Moderate (2)
(Comment:en)
CL Item
Severe (3)
(Comment:en)
CL Item
Not applicable (X)
(Comment:en)
Item
Intensity at onset of event
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Intensity at onset of event
CL Item
Mild (1)
(Comment:en)
CL Item
Moderate (2)
(Comment:en)
CL Item
Severe (3)
(Comment:en)
CL Item
Not applicable (X)
(Comment:en)
Item
Maximum Grade
integer
C0441799 (UMLS CUI [1])
Serious Adverse Event Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade at onset of event
integer
C2985911 (UMLS CUI [1])
Serious Adverse Event Maximum Grade
Code List
Grade at onset of event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Serious Adverse Event Maximum Grade
Code List
Maximum Grade 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
Grade 5 (5)
CL Item
Not applicable (X)
Item
Grade or Intensity at onset of event
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Serious Adverse Event Maximum Grade
Code List
Grade or Intensity at onset of event
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
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
lnvestigational product(s) 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)
Relationship investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
SAE Causation
Item
Was SAE caused by activities related to study participation (e.g.procedures)?
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
investigational product
Item
Related investigational product
text
C0304229 (UMLS CUI [1])
Item Group
Intensity changes
Serious Adverse Event Intensity changes
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Start Date of event segment
Item
Start Date of event segment
date
C2697888 (UMLS CUI [1])
Start Time of event segment
Item
Start Time of event segment Hr:Min (00:00-23:59)
time
C2697889 (UMLS CUI [1])
Item
Intensity of event segment
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Maximum Intensity
Code List
Intensity of event segment
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Grade of event segment
integer
C2985911 (UMLS CUI [1])
Grade at onset of event
Code List
Grade of event segment
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Grade or Intensity of event segment
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Grade or Intensity at onset of event
Code List
Grade or Intensity of event segment
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
Grade 5 (5)
Item Group
Seriousness
C0871902 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other (6)
Seriousness Other
Item
Seriousness: If other, specify:
text
C1710056 (UMLS CUI [1])
Item Group
Relevant concomitant / treatment medications
CM Sequence Number
Item
CM Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Item
Unit
text
C1519795 (UMLS CUI [1])
units of medication
Code List
Unit
CL Item
Actuation (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (AP)
CL Item
Bottle  (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops  (031)
CL Item
Gram (002)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre (011)
CL Item
Litre per minute (LM)
CL Item
Lozenge (LOZ)
CL Item
Megaunits (million units) (MEGU)
CL Item
Microgram (UG) (004)
CL Item
Microgram (UG) (004)
CL Item
Microgram/kilogram  (008)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Microlitre (013)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligram (003)
CL Item
Milligrams percent (MGPER)
CL Item
Milligram per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/kilogram per minute (MGKM)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre (012)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million international units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebule (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet (SAC)
CL Item
Spray (SPR)
CL Item
Suppository (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial (VIA)
Item
Frequency
text
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
3 times per week (2W)
CL Item
3 times per week (2W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
AC (AC)
CL Item
Q12H (2D)
CL Item
Continuous infusion (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3W)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
QPM (1N)
CL Item
Once a month (MO)
CL Item
Once a week (WE)
CL Item
Once daily (1D)
CL Item
Once only (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H (6D)
CL Item
QID (4D)
CL Item
TID (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (1N)
CL Item
TID (3D)
CL Item
Unknown (U)
Item
Route
text
C0013153 (UMLS CUI [1])
Route of medication
Code List
Route
CL Item
Both eyes (047)
C0229118 (UMLS CUI-1)
(Comment:en)
CL Item
Epidural (008)
C0014537 (UMLS CUI-1)
(Comment:en)
CL Item
Gastrostomy tube (GT)
C0017196 (UMLS CUI-1)
C0041281 (UMLS CUI-2)
(Comment:en)
CL Item
Inhalation (055)
C0004048 (UMLS CUI-1)
(Comment:en)
CL Item
Injection (INJ)
C1272883 (UMLS CUI-1)
(Comment:en)
CL Item
Intra-arterial (013)
C0694634 (UMLS CUI-1)
(Comment:en)
CL Item
Intra-bursa (IBU)
C0230212 (UMLS CUI-1)
(Comment:en)
CL Item
Intralesional (026)
C1512954 (UMLS CUI-1)
(Comment:en)
CL Item
Intramuscular (030)
C0442117 (UMLS CUI-1)
(Comment:en)
CL Item
Nasal (045)
C0442118 (UMLS CUI-1)
(Comment:en)
CL Item
Intraocular (031)
CL Item
Intraosteal (IOS)
CL Item
Intraperitoneal (033)
CL Item
Intrathecal (037)
CL Item
Intrauterine (015)
CL Item
Intravenous (042)
CL Item
Nasal (045)
CL Item
Oral (048)
CL Item
Rectal (054)
CL Item
Subcutaneous (058)
CL Item
Sublingual (060)
CL Item
Topical (061)
CL Item
Transdermal (062)
CL Item
Unknown (065)
CL Item
Vaginal (067)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Ongoing medication
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
End date medication
Item
If no ongoing medication, specify end date
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication
Item
Primary Indication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Drug Type
Code List
Drug Type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Relevant diagnostic results
Lab Sequence Number
Item
Lab Sequence Number
text
C2348184 (UMLS CUI [1])
Item
Test Name
text
C0022885 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
Activated partial thromboplastin time (Activated partial thromboplastin time)
C0030605 (UMLS CUI-1)
(Comment:en)
CL Item
Alanine Amino Transferase (Alanine aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
Albumin (Albumin)
C0201838 (UMLS CUI-1)
(Comment:en)
CL Item
Alkaline phosphatase (Alkaline phosphatase)
C0201850 (UMLS CUI-1)
(Comment:en)
CL Item
Amylase (Amylase)
C0201883 (UMLS CUI-1)
(Comment:en)
CL Item
Aspartate Amino Transferase (Aspartate aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
Basophils (Basophils)
C0004827 (UMLS CUI-1)
(Comment:en)
CL Item
Bicarbonate (Bicarbonate)
C0202059 (UMLS CUI-1)
(Comment:en)
CL Item
Bilirubin (Bilirubin)
C1278039 (UMLS CUI-1)
(Comment:en)
CL Item
Bilirubin direct (Bilirubin direct)
C0201916 (UMLS CUI-1)
(Comment:en)
CL Item
Bilirubin total (Bilirubin total)
CL Item
Blood myoglobin (Blood myoglobin)
CL Item
Blood pH (Blood pH)
CL Item
Blood pressure (Blood pressure)
CL Item
Blood urea nitrogen (Blood urea nitrogen)
CL Item
Body temperature (Body temperature)
CL Item
Calcium (Calcium)
CL Item
CD4 lymphocytes (CD4 lymphocytes)
CL Item
CD8 lymphocytes (CD8 lymphocytes)
CL Item
Chloride (Chloride)
CL Item
Cholesterol total (Cholesterol total)
CL Item
C-reactive protein (C-reactive protein)
CL Item
Creatine (Creatine)
CL Item
Creatine phosphokinase (Creatine phosphokinase)
CL Item
Creatine phosphokinase MB (Creatine phosphokinase MB)
CL Item
Creatinine (Creatinine)
CL Item
Creatinine clearance (Creatinine clearance)
CL Item
Diastolic blood pressure (Diastolic blood pressure)
CL Item
Eosinophils (Eosinophils)
CL Item
Erythrocyte sedimentation rate (Erythrocyte sedimentation rate)
CL Item
Fasting blood glucose (Fasting blood glucose)
CL Item
FEV 1 (FEV 1)
CL Item
Gamma-glutamyltransferase (Gamma-glutamyltransferase)
CL Item
HbA1c (HbA1c)
CL Item
HBV-DNA decreased (HBV-DNA decreased)
CL Item
HBV-DNA increased (HBV-DNA increased)
CL Item
Heart rate (Heart rate)
CL Item
Hematocrit (Hematocrit)
CL Item
Hemoglobin (Hemoglobin)
CL Item
High density lipoprotein (High density lipoprotein)
CL Item
HIV viral load (HIV viral load)
CL Item
INR (INR)
CL Item
Lactic dehydrogenase (Lactic dehydrogenase)
CL Item
Lipase (Lipase)
CL Item
Low density lipoprotein (Low density lipoprotein)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Magnesium (Magnesium)
CL Item
Mean cell hemoglobin concentration (Mean cell hemoglobin concentration)
CL Item
Mean corpuscular hemoglobin (Mean corpuscular hemoglobin)
CL Item
Mean corpuscular volume (Mean corpuscular volume)
CL Item
Monocytes (Monocytes)
CL Item
Neutrophils (Neutrophils)
CL Item
Oxygen saturation (Oxygen saturation)
CL Item
pCO2 (pCO2)
CL Item
pH (pH)
CL Item
Phosphate (Phosphate)
CL Item
Platelet count (Platelet count)
CL Item
pO2 (pO2)
CL Item
Potassium (Potassium)
CL Item
Protein total (Protein total)
CL Item
Prothrombin time (Prothrombin time)
CL Item
Red blood cell count (Red blood cell count)
CL Item
Respiratory rate (Respiratory rate)
CL Item
Reticulocyte count (Reticulocyte count)
CL Item
Serum glucose (Serum glucose)
CL Item
Serum uric acid (Serum uric acid)
CL Item
Sodium (Sodium)
CL Item
Systolic blood pressure (Systolic blood pressure)
CL Item
Thrombin time (Thrombin time)
CL Item
Total lung capacity (Total lung capacity)
CL Item
Triglycerides (Triglycerides)
CL Item
Troponin (Troponin)
CL Item
Troponin I (Troponin I)
CL Item
Troponin T (Troponin T)
CL Item
Urine myoglobin (Urine myoglobin)
CL Item
Urine pH (Urine pH)
CL Item
Vital capacity (Vital capacity)
CL Item
White blood cell count (White blood cell count)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0456984 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
text
C2700150 (UMLS CUI [1])
Normal High Range
Item
Normal High Range
text
C2700149 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Rechallenge
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
INVESTIGATIONAL PRODUCT
C0304229 (UMLS CUI-1)
Drug
Item
Study drug
text
C0013227 (UMLS CUI [1])
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Regimen
Item
Regimen
text
C1276413 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
General narrative comments
General narrative comments
Item
General narrative comments
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Non clinical
incomplete SAE data GSK Safety
Item
22. [3] Incomplete SAE
boolean
C1710056 (UMLS CUI [1])
Receipt by GSK date
Item
23. Receipt by GSK date
date
C2985846 (UMLS CUI [1])
Receipt by GSK date
Item
23. Receipt by GSK date
date
C2985846 (UMLS CUI [1])
serious SAE
Item
24. Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
25. SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
26. Version Number
integer
C2985700 (UMLS CUI [1])
Case ID
Item
27. Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
28. Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
29. OCEANS Code
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
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