Informations:
Erreur:
ID
41974
Description
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
Mots-clés
Versions (1)
- 09/03/2021 09/03/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
9 mars 2021
DOI
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Licence
Creative Commons BY 4.0
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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356
Logs and Repeats - Logs and Repeats; Non-Serious Adverse Events; Serious Adverse Events
Similar models
Logs and Repeats - Logs and Repeats; Non-Serious Adverse Events; Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
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])
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)
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0205341 (UMLS CUI [1,2])
Non-Serious Adverse Event - Sequence Number
Item
Non-Serious Adverse Event - Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
C1705586 (UMLS CUI [1,2])
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])
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])
C0439603 (UMLS CUI [1,2])
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])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
C1704758 (UMLS CUI [1,2])
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])
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])
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)
C0332307 (UMLS CUI-2)
Item
Serious Adverse Event - Type of Report
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Initial (1)
CL Item
Follow-Up (2)
Item Group
Serious Adverse Event - Randomisation
C3897642 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
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])
C0304229 (UMLS CUI [1,2])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
C1705586 (UMLS CUI [1,2])
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])
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])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
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])
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])
C1519255 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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
Specify the reason for considering this an SAE.
text
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
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)
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])
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])
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])
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])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
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])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
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])
C2826730 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C2347852 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,3])
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)
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])
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])
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])
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])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
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])
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])
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)
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])
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])
C0430022 (UMLS CUI [2,1])
C2826273 (UMLS CUI [2,2])
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])
C2826247 (UMLS CUI [2])
Serious Adverse Event - Test Result
Item
Serious Adverse Event - Test Result
text
C1519255 (UMLS CUI [1])
C0456984 (UMLS CUI [2])
C0456984 (UMLS CUI [2])
Serious Adverse Event - Test Units
Item
Serious Adverse Event - Test Units
text
C1519255 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
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])
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])
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])
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)
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])
C0034897 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
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)
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])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
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])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])