ID

41974

Descripción

Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Palabras clave

Versiones (1)
  1. 9/3/21 9/3/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de marzo de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356

Inglés

Logs and Repeats - Logs and Repeats; Non-Serious Adverse Events; Serious Adverse Events

1 formularios  
Logs and Repeats - Date of visit/assessment
Descripción

Logs and Repeats - Date of visit/assessment

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0205341
UMLS CUI-3
C1320303
UMLS CUI-4
C2985720
Date of visit/assessment
Descripción

Date of visit/assessment

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Logs and Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Descripción

Logs and Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0205341
UMLS CUI-3
C0877248
UMLS CUI-4
C2347852
UMLS CUI-5
C0205341
UMLS CUI-6
C0220825
Were any concomitant medications taken by the subject during the study?
Descripción

Were any concomitant medications taken by the subject during the study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Descripción

Did the subject experience any non-serious adverse events during the study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Descripción

Did the subject experience any serious adverse events during the study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Were any repeat ECGs performed?
Descripción

Were any repeat ECGs performed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Descripción

Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat vital signs recorded?
Descripción

Were any repeat vital signs recorded?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat haematology or clinical chemistry samples taken?
Descripción

Were any repeat haematology or clinical chemistry samples taken?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0018941
UMLS CUI [2,3]
C0200345
Were any urinalysis samples taken?
Descripción

Were any urinalysis samples taken?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
Were any repeat Pulmonary Function Tests performed?
Descripción

Were any repeat Pulmonary Function Tests performed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0205341
Were any repeat Total Nasal Symptom Scores performed?
Descripción

Were any repeat Total Nasal Symptom Scores performed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3533163
UMLS CUI [1,2]
C0028429
UMLS CUI [1,3]
C0205341
Were any Rhinomanometry assessments performed?
Descripción

Were any Rhinomanometry assessments performed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430615
UMLS CUI [1,2]
C0205341
Were any repeat Nasal Examinations performed?
Descripción

Were any repeat Nasal Examinations performed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0558826
UMLS CUI [1,2]
C0205341
Were any repeat Visual Analogue Scale assessments performed?
Descripción

Were any repeat Visual Analogue Scale assessments performed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2959685
UMLS CUI [1,2]
C0205341
Non-Serious Adverse Event
Descripción

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Non-Serious Adverse Event - Sequence Number
Descripción

Non-Serious Adverse Event - Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Non-Serious Adverse Event - Event
Descripción

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event - Modified term
Descripción

Non-Serious Adverse Event - Modified term

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826798
Non-Serious Adverse Event - MedDRA synonym
Descripción

Non-Serious Adverse Event - MedDRA synonym

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1140263
Non-Serious Adverse Event - MedDRA lower level term code
Descripción

Non-Serious Adverse Event - MedDRA lower level term code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C3898442
Non-Serious Adverse Event - Failed coding
Descripción

Non-Serious Adverse Event - Failed coding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Non-Serious Adverse Event - Start Date and Time
Descripción

Non-Serious Adverse Event - Start Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1301880
Non-Serious Adverse Event - Outcome
Descripción

Non-Serious Adverse Event - Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious Adverse Event - End Date and Time
Descripción

Non-Serious Adverse Event - End Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C1522314
Non-Serious Adverse Event - Frequency
Descripción

Non-Serious Adverse Event - Frequency

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-Serious Adverse Event - Maximum Intensity
Descripción

Non-Serious Adverse Event - Maximum Intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Non-Serious Adverse Event - Action Taken with Investigational Product(s) as a Result of the AE
Descripción

Non-Serious Adverse Event - Action Taken with Investigational Product(s) as a Result of the AE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Serious Adverse Event - Type of Report
Descripción

Serious Adverse Event - Type of Report

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C0332307
Serious Adverse Event - Type of Report
Descripción

Serious Adverse Event - Type of Report

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Serious Adverse Event - Randomisation
Descripción

Serious Adverse Event - Randomisation

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C0034656
Did SAE occur after initiation of study medication?
Descripción

Did SAE occur after initiation of study medication?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event
Descripción

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Descripción

SAE Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event - Event
Descripción

Diagnosis Only (if known) Otherwise Sign/Symptom

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Modified term
Descripción

Serious Adverse Event - Modified term

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
Serious Adverse Event - MedDRA synonym
Descripción

Serious Adverse Event - MedDRA synonym

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
Serious Adverse Event - MedDRA lower level term code
Descripción

Serious Adverse Event - MedDRA lower level term code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Serious Adverse Event - Failed coding
Descripción

Serious Adverse Event - Failed coding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Serious Adverse Event - Start Date and Time
Descripción

Serious Adverse Event - Start Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1301880
Serious Adverse Event - Outcome
Descripción

Serious Adverse Event - Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Event - End Date and Time
Descripción

Serious Adverse Event - End Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1522314
Serious Adverse Event - Maximum Intensity
Descripción

Serious Adverse Event - Maximum Intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Serious Adverse Event - Maximum Grade
Descripción

Serious Adverse Event - Maximum Grade

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Serious Adverse Event - Maximum Grade or Intensity
Descripción

Serious Adverse Event - Maximum Grade or Intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0518690
UMLS CUI [2,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the AE
Descripción

Action Taken with Investigational Product(s) as a Result of the AE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Serious Adverse Event - Did the subject withdraw from study as a result of the AE?
Descripción

Serious Adverse Event - Did the subject withdraw from study as a result of the AE?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Serious Adverse Event - Is there a reasonable possibility that the AE may have been caused by investigational product?
Descripción

Serious Adverse Event - Is there a reasonable possibility that the AE may have been caused by investigational product?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Serious Adverse Event - Duration of AE if < 24 hours
Descripción

Serious Adverse Event - Duration of AE if < 24 hours

Tipo de datos

integer

Unidades de medida
  • Hr(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Hr(s)
Serious Adverse Event - Duration of AE if < 24 hours
Descripción

Serious Adverse Event - Duration of AE if < 24 hours

Tipo de datos

integer

Unidades de medida
  • Min(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Min(s)
Time to Onset Since Last Dose
Descripción

Time to Onset Since Last Dose

Tipo de datos

integer

Unidades de medida
  • Hr(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C0946444
Hr(s)
Time to Onset Since Last Dose
Descripción

Time to Onset Since Last Dose

Tipo de datos

integer

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

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
Was the event serious?
Descripción

Was the event serious?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event - Serious
Descripción

Serious Adverse Event - Serious

Alias
UMLS CUI-1
C1519255
Specify the reason for considering this an SAE.
Descripción

Check all that apply.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0392360
Serious Adverse Event - Relevant Concomitant/Treatment Medications
Descripción

Serious Adverse Event - Relevant Concomitant/Treatment Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
UMLS CUI-3
C0013227
Seroius Adverse Event - CM Sequence Number
Descripción

Seroius Adverse Event - CM Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2348184
Serious Adverse Event - Concomitant Medication Drug Name
Descripción

Trade Name preferred

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2360065
Serious Adverse Event - Concomitant Medication Dose
Descripción

Serious Adverse Event - Concomitant Medication Dose

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
Serious Adverse Event - Concomitant Medication Unit
Descripción

Serious Adverse Event - Concomitant Medication Unit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439148
Serious Adverse Event - Concomitant Medication Frequency
Descripción

Serious Adverse Event - Concomitant Medication Frequency

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3476109
Serious Adverse Event - Concomitant Medication Route
Descripción

Serious Adverse Event - Concomitant Medication Route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826730
Serious Adverse Event - Concomitant Medication Start Date
Descripción

Serious Adverse Event - Concomitant Medication Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826734
Serious Adverse Event - Concomitant Medication Ongoing?
Descripción

If No, specify End Date.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
Serious Adverse Event - Concomitant Medication End Date
Descripción

Serious Adverse Event - Concomitant Medication End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826744
Serious Adverse Event - Concomitant Medication Primary Indication
Descripción

Serious Adverse Event - Concomitant Medication Primary Indication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Serious Adverse Event - Concomitant Medication Drug Type
Descripción

Serious Adverse Event - Concomitant Medication Drug Type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0457591
Serious Adverse Event - Relevant Medical Conditions/Risk Factors
Descripción

Serious Adverse Event - Relevant Medical Conditions/Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
UMLS CUI-3
C0035648
Serious Adverse Event - MHX Sequence Number
Descripción

Serious Adverse Event - MHX Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
UMLS CUI [1,3]
C0262926
Serious Adverse Event - Specific Condition NAme
Descripción

Serious Adverse Event - Specific Condition NAme

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2348235
Serious Adverse Event - Condition Date of onset
Descripción

Serious Adverse Event - Condition Date of onset

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0574845
Serious Adverse Event - Condition Continuing?
Descripción

Serious Adverse Event - Condition Continuing?

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0549178
Serious Adverse Event - Date of last occurence of condition
Descripción

Serious Adverse Event - Date of last occurence of condition

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C1517741
Serious Adverse Event - Relevant Medical History/Risk Factors not noted above
Descripción

Serious Adverse Event - Relevant Medical History/Risk Factors not noted above

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0035648
UMLS CUI [1,4]
C0205394
Serious Adverse Event - Relevant Diagnostic Results
Descripción

Serious Adverse Event - Relevant Diagnostic Results

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
Serious Adverse Event - Lab Sequence Number
Descripción

Serious Adverse Event - Lab Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C2348184
Serious Adverse Event - Test Name
Descripción

Serious Adverse Event - Test Name

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0430022
UMLS CUI [2,2]
C2826273
Serious Adverse Event - Test Date
Descripción

Serious Adverse Event - Test Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C2826247
Serious Adverse Event - Test Result
Descripción

Serious Adverse Event - Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0456984
Serious Adverse Event - Test Units
Descripción

Serious Adverse Event - Test Units

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C1519795
Serious Adverse Event - Normal Low Range
Descripción

Serious Adverse Event - Normal Low Range

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Serious Adverse Event - Normal High Range
Descripción

Serious Adverse Event - Normal High Range

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Serious Adverse Event - Relevant diagnostic results not noted above
Descripción

Serious Adverse Event - Relevant diagnostic results not noted above

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0430022
UMLS CUI [2,2]
C0456984
UMLS CUI [2,3]
C0205394
C0430022 C0456984 C0205394
Descripción

C0430022 C0456984 C0205394

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0013230
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Descripción

If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0034897
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C0457454
Serious Adverse Event - General Narrative Comments
Descripción

Serious Adverse Event - General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General narrative comments
Descripción

Provide a brief 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 condition(s) and details of the treatment.

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Serious Adverse Event - No clinical
Descripción

Serious Adverse Event - No clinical

Alias
UMLS CUI-1
C1519255
Send incomplete SAE data to GSK Safety
Descripción

Send incomplete SAE data to GSK Safety

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0205257
Receipt by GSK date
Descripción

Receipt by GSK date

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2985846
Was the event serious?
Descripción

Was the event serious?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Descripción

SAE Sequence Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Descripción

Version Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0333052
UMLS CUI [1,2]
C0237753
Case ID
Descripción

Case ID

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Descripción

Randomisation Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Descripción

OCEANS Code

Tipo de datos

text

Alias
UMLS CUI [1]
C0805701
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Similar models

Logs and Repeats - Logs and Repeats; Non-Serious Adverse Events; Serious Adverse Events

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Logs and Repeats - Date of visit/assessment
C1708728 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C1320303 (UMLS CUI-3)
C2985720 (UMLS CUI-4)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Logs and Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C1708728 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C2347852 (UMLS CUI-4)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Did the subject experience any serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat haematology or clinical chemistry samples taken?
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
Were any urinalysis samples taken?
Item
Were any urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Were any repeat Pulmonary Function Tests performed?
Item
Were any repeat Pulmonary Function Tests performed?
boolean
C0024119 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat Total Nasal Symptom Scores performed?
Item
Were any repeat Total Nasal Symptom Scores performed?
boolean
C3533163 (UMLS CUI [1,1])
C0028429 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Were any Rhinomanometry assessments performed?
Item
Were any Rhinomanometry assessments performed?
boolean
C0430615 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat Nasal Examinations performed?
Item
Were any repeat Nasal Examinations performed?
boolean
C0558826 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat Visual Analogue Scale assessments performed?
Item
Were any repeat Visual Analogue Scale assessments performed?
boolean
C2959685 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event - Sequence Number
Item
Non-Serious Adverse Event - Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-Serious Adverse Event - Event
Item
Non-Serious Adverse Event - Event
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event - Modified term
Item
Non-Serious Adverse Event - Modified term
text
C1518404 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Non-Serious Adverse Event - MedDRA synonym
Item
Non-Serious Adverse Event - MedDRA synonym
text
C1518404 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Non-Serious Adverse Event - MedDRA lower level term code
Item
Non-Serious Adverse Event - MedDRA lower level term code
text
C1518404 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Non-Serious Adverse Event - Failed coding
Item
Non-Serious Adverse Event - Failed coding
text
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Non-Serious Adverse Event - Start Date and Time
Item
Non-Serious Adverse Event - Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Non-Serious Adverse Event - Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event - Outcome
Code List
Non-Serious Adverse Event - Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provid End Date and Time (4)
Non-Serious Adverse Event - End Date and Time
Item
Non-Serious Adverse Event - End Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Non-Serious Adverse Event - Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event - Frequency
Code List
Non-Serious Adverse Event - Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event - Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event - Maximum Intensity
Code List
Non-Serious Adverse Event - Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Non-Serious Adverse Event - Action Taken with Investigational Product(s) as a Result of the AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-Serious Adverse Event - Action Taken with Investigational Product(s) as a Result of the AE
Code List
Non-Serious Adverse Event - Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational 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 (X)
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])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Type of Report
C3897642 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Serious Adverse Event - Type of Report
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Serious Adverse Event - Type of Report
Code List
Serious Adverse Event - Type of Report
CL Item
Initial (1)
CL Item
Follow-Up (2)
Item Group
Serious Adverse Event - Randomisation
C3897642 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
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])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event - Event
Item
Serious Adverse Event - Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event - Modified term
Item
Serious Adverse Event - Modified term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA synonym
Item
Serious Adverse Event - MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Serious Adverse Event - MedDRA lower level term code
Item
Serious Adverse Event - MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event - Failed coding
Item
Serious Adverse Event - Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event - Start Date and Time
Item
Serious Adverse Event - Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Serious Adverse Event - Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event - Outcome
Code List
Serious Adverse Event - Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Serious Adverse Event - End Date and Time
Item
Serious Adverse Event - End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Serious Adverse Event - Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Intensity
Code List
Serious Adverse Event - Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not Applicable (X)
Item
Serious Adverse Event - Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Serious Adverse Event - Maximum Grade
Code List
Serious Adverse Event - 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)
CL Item
Not applicable (X)
Item
Serious Adverse Event - Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Serious Adverse Event - Maximum Grade or Intensity
Code List
Serious Adverse Event - 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
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational 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 (X)
Serious Adverse Event - Did the subject withdraw from study as a result of the AE?
Item
Serious Adverse Event - Did the subject withdraw from study as a result of the AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event - Is there a reasonable possibility that the AE may have been caused by investigational product?
Item
Serious Adverse Event - Is there a reasonable possibility that the AE may have been caused by investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Serious Adverse Event - Duration of AE if < 24 hours
Item
Serious Adverse Event - Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Serious Adverse Event - Duration of AE if < 24 hours
Item
Serious Adverse Event - 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])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Was SAE caused by activities related to study participation (e.g. procedures)?
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Serious Adverse Event - Serious
C1519255 (UMLS CUI-1)
Item
Specify the reason for considering this an SAE.
text
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Specify the reason for considering this an SAE.
Code List
Specify the reason for considering this an SAE.
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)
Item Group
Serious Adverse Event - Relevant Concomitant/Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
Seroius Adverse Event - CM Sequence Number
Item
Seroius Adverse Event - CM Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event - Concomitant Medication Drug Name
Item
Serious Adverse Event - Concomitant Medication Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event - Concomitant Medication Dose
Item
Serious Adverse Event - Concomitant Medication Dose
float
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Item
Serious Adverse Event - Concomitant Medication Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Serious Adverse Event - Concomitant Medication Unit
Code List
Serious Adverse Event - Concomitant Medication 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 (MCG) (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 perecent (MGPER)
CL Item
Milligrams per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre (012)
CL Item
Millilitre per hour (MLH)
CL Item
Mllilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million international units (027)
CL Item
Minimum alveolar concentratino (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
Serious Adverse Event - Concomitant Medication Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
Serious Adverse Event - Concomitant Medication Frequency
Code List
Serious Adverse Event - Concomitant Medication Frequency
CL Item
2 times per week (2W)
CL Item
3 times per week (3W)
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
BID (2D)
CL Item
Continuous infusion (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3WK)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
At Bedtime (IN)
CL Item
Once a month (MO)
CL Item
Once a week (WE)
CL Item
Oncedaily (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
Q6H (4D)
CL Item
Q8H (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (IN)
CL Item
TID (3D)
CL Item
Unknown (U)
Item
Serious Adverse Event - Concomitant Medication Route
text
C1519255 (UMLS CUI [1,1])
C2826730 (UMLS CUI [1,2])
Serious Adverse Event - Concomitant Medication Route
Code List
Serious Adverse Event - Concomitant Medication Route
CL Item
Both eyes (047)
CL Item
Epidural (008)
CL Item
Gastrostomy tube (GT)
CL Item
Inhalation (055)
CL Item
Injection (INJ)
CL Item
Intra-arterial (013)
CL Item
Intra-brusa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Intranasal (045)
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)
Serious Adverse Event - Concomitant Medication Start Date
Item
Serious Adverse Event - Concomitant Medication Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
Serious Adverse Event - Concomitant Medication Ongoing?
Item
Serious Adverse Event - Concomitant Medication Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event - Concomitant Medication End Date
Item
Serious Adverse Event - Concomitant Medication End Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Serious Adverse Event - Concomitant Medication Primary Indication
Item
Serious Adverse Event - Concomitant Medication Primary Indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item
Serious Adverse Event - Concomitant Medication Drug Type
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,3])
Serious Adverse Event - Concomitant Medication Drug Type
Code List
Serious Adverse Event - Concomitant Medication Drug Type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Serious Adverse Event - Relevant Medical Conditions/Risk Factors
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
Serious Adverse Event - MHX Sequence Number
Item
Serious Adverse Event - MHX Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Serious Adverse Event - Specific Condition NAme
Item
Serious Adverse Event - Specific Condition NAme
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Serious Adverse Event - Condition Date of onset
Item
Serious Adverse Event - Condition Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Item
Serious Adverse Event - Condition Continuing?
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event - Condition Continuing?
Code List
Serious Adverse Event - Condition Continuing?
CL Item
Yes (Y)
CL Item
No, specify date of last occurence (N)
CL Item
Unknown (U)
Serious Adverse Event - Date of last occurence of condition
Item
Serious Adverse Event - Date of last occurence of condition
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
Serious Adverse Event - Relevant Medical History/Risk Factors not noted above
Item
Serious Adverse Event - Relevant Medical History/Risk Factors not noted above
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Serious Adverse Event - Relevant Diagnostic Results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Serious Adverse Event - Lab Sequence Number
Item
Serious Adverse Event - Lab Sequence Number
integer
C1519255 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C2348184 (UMLS CUI [2,2])
Item
Serious Adverse Event - Test Name
integer
C1519255 (UMLS CUI [1])
C0430022 (UMLS CUI [2,1])
C2826273 (UMLS CUI [2,2])
Serious Adverse Event - Test Name
Code List
Serious Adverse Event - Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbinate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transferase (32)
CL Item
Glutamic-pyruvate transaminae (33)
CL Item
HbA1c (34)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA icreased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pCO2 (54)
CL Item
pH (55)
CL Item
Phosphate (56)
CL Item
Platelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Serious Adverse Event - Test Date
Item
Serious Adverse Event - Test Date
date
C1519255 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Serious Adverse Event - Test Result
Item
Serious Adverse Event - Test Result
text
C1519255 (UMLS CUI [1])
C0456984 (UMLS CUI [2])
Serious Adverse Event - Test Units
Item
Serious Adverse Event - Test Units
text
C1519255 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Serious Adverse Event - Normal Low Range
Item
Serious Adverse Event - Normal Low Range
integer
C1519255 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Serious Adverse Event - Normal High Range
Item
Serious Adverse Event - Normal High Range
integer
C1519255 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Serious Adverse Event - Relevant diagnostic results not noted above
Item
Serious Adverse Event - Relevant diagnostic results not noted above
text
C1519255 (UMLS CUI [1])
C0430022 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
Item Group
C0430022 C0456984 C0205394
C1519255 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1])
C0034897 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C0947611 (UMLS CUI [1])
Item Group
Serious Adverse Event - No clinical
C1519255 (UMLS CUI-1)
Item
Send incomplete SAE data to GSK Safety
integer
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Send incomplete SAE data to GSK Safety
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (3)
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
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