Informatie:
Fout:
ID
38622
Beschrijving
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis
Trefwoorden
Versies (1)
- 28/10/19 28/10/19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
28 ottobre 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs
Similar models
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
C1516048 (UMLS CUI-4)
C2347852 (UMLS CUI-5)
C1516048 (UMLS CUI-6)
C0205341 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C1516048 (UMLS CUI-4)
C2347852 (UMLS CUI-5)
C1516048 (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 abnormal ECG measurements recorded for this subject during the study?
Item
Were any abnormal ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
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])
C0200345 (UMLS CUI [1,2])
Were any repeat urinalysis samples taken?
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
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 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 PK blood samples taken?
Item
Were any repeat PK blood samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Werw any repeat VAS taken?
Item
Werw any repeat VAS taken?
boolean
C2732809 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Were any repeat Nasal Endoscopies taken?
Item
Were any repeat Nasal Endoscopies taken?
boolean
C0189024 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Were any repeat Visual Nasal Exams taken?
Item
Were any repeat Visual Nasal Exams taken?
boolean
C0558826 (UMLS CUI [1,1])
C0042812 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0042812 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (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
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
Non-serious Adverse Event Start Date and Time
Item
Non-serious Adverse Event Start Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C1518404 (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, provide 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
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Non-serious Adverse Event Maximum Grade
integer
C1518404 (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 (6)
Item
Non-serious Adverse Event Maximum Grade or Intensity
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Code List
Non-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 (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (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 (6)
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])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (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])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
CL Item
Initial (1)
CL Item
Follow- Up (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])
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
Item
Serious Adverse Event
text
C1519255 (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
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
Serious Adverse Events Start Date and Time
Item
Serious Adverse Events 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 Events Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date and Time of Death (5)
Serious Adverse Events End Date and Time
Item
Serious Adverse Events 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 Events Maximum Intensity
integer
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 (4)
Item
Serious Adverse Event Maximum Grade
integer
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 (6)
Item
Serious Adverse Event Maximum Grade or Intensity
integer
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 (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
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 (6)
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])
C1519255 (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
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])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
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
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
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
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Specify the reason for considering this an SAE
text
C1710056 (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 - Concomitant Medication
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
CM Sequence Number
Item
CM Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
International units per millilitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
Lozenge (14)
CL Item
Megaunits (million units) (15)
CL Item
Microgram (MCG) (16)
CL Item
Microgram (UG) (17)
CL Item
Microgram/kilogram (18)
CL Item
Microgram/kilogram per minute (19)
CL Item
Micrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligram per hour (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour (28)
CL Item
Milligram/kilogram per minute (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour (33)
CL Item
Millilitre per minute (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration (37)
CL Item
Nebule (38)
CL Item
Patch (39)
CL Item
Percent (40)
CL Item
Puff (41)
CL Item
Sachet (42)
CL Item
Spray (43)
CL Item
Suppository (44)
CL Item
Tablespoon (45)
CL Item
Tablet (46)
CL Item
Teaspoon (47)
CL Item
Units (48)
CL Item
Unknown (49)
CL Item
Vial (50)
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At Bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TID (31)
CL Item
Unknown (32)
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-arterial (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Concomitant Medication Start Date
Item
Concomitant Medication Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication Ongoing?
Item
Concomitant Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
If concomitant medication not ongoing, specify end date
Item
If concomitant medication not ongoing, specify end date
date
C2826666 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
Concomitant medication Primary Indication
Item
Concomitant medication Primary Indication
text
C2826696 (UMLS CUI [1])
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Serious Adverse Event - Medical Conditions/ Risk Factors
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
MHx Sequence Number
Item
MHx Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
datetime
C0574845 (UMLS CUI [1])
Item
Medical Conditions/ Risk Factors Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Item
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
Relevant Medical History/ Risk Factors not noted above
Item
Relevant Medical History/ Risk Factors not noted above
text
C0012634 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
C0035648 (UMLS CUI [2])
Item Group
Serious Adverse Events - Relevant diagnostic results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
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
Bicarbonate (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
FEV 1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transferase (32)
CL Item
Glutamic-pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA increased (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)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Item Group
Serious Adverse Events - Investigational Products
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
C0013230 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C1272691 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
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 Events - 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 Events - Non clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
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
integer
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])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
Sequence number
Item
Sequence number
integer
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])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
text
C0869039 (UMLS CUI [1])
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Area under curve (4)
CL Item
Bottle (5)
CL Item
Capsule (6)
CL Item
Cubic centimeter (7)
CL Item
Cup (8)
CL Item
Gamma per kilogram per minute (9)
CL Item
Gram (10)
CL Item
Drops (11)
CL Item
100 International units/ml (12)
CL Item
Inhalation (13)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour (16)
CL Item
International units per millilitre (17)
CL Item
Litre (18)
CL Item
Lozenge (19)
CL Item
Litre per minute (20)
CL Item
Minimum alveolar concentration (21)
CL Item
Mega becquerels (MBq) MBQ (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour (24)
CL Item
Microgram/kilogram (25)
CL Item
Microgram/kilogram per minute (26)
CL Item
Micrograms per minute (27)
CL Item
Micrograms per millitre (28)
CL Item
Microlitre (29)
CL Item
Milliequivalent (30)
CL Item
Milliequivalent per 24 (31)
CL Item
Milligram (32)
CL Item
Milligram per day (33)
CL Item
Milligram per hour (34)
CL Item
Milligram/kilogram (35)
CL Item
Milligram/kilogram per hour (36)
CL Item
Milligram/kilogram per minute (37)
CL Item
Milligram/metre squared (38)
CL Item
Milligram/millilitre (39)
CL Item
Milligrams percent (40)
CL Item
Million international units (41)
CL Item
Millilitre (42)
CL Item
Millilitre per hour (43)
CL Item
Millilitre per minute (44)
CL Item
Millimole (45)
CL Item
Megaunits (million units) (46)
CL Item
Nebule (47)
CL Item
Ounce (48)
CL Item
Patch (49)
CL Item
Percent (50)
CL Item
Puff (51)
CL Item
Sachet (52)
CL Item
Spray (53)
CL Item
Suppository (54)
CL Item
Tablet (55)
CL Item
Tablespoon (56)
CL Item
Teaspoon (57)
CL Item
Microgram (UG) (58)
CL Item
Units per hour (59)
CL Item
Units per kilogram per minute (60)
CL Item
Units per minute (61)
CL Item
Units (62)
CL Item
Unknown (63)
CL Item
Vial (64)
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
HS (9)
CL Item
Once daily (10)
CL Item
Once only (11)
CL Item
PC (12)
CL Item
PRN (13)
CL Item
Q12H (14)
CL Item
Q2H (15)
CL Item
Every 2 weeks (16)
CL Item
Q3D (17)
CL Item
Every 3 months (18)
CL Item
Every 3 weeks (19)
CL Item
Q4D (20)
CL Item
Q4H (21)
CL Item
Q6H (22)
CL Item
Q8H (23)
CL Item
QAM (24)
CL Item
QH (25)
CL Item
QID (26)
CL Item
Once a month (27)
CL Item
Every other day (28)
CL Item
QPM (29)
CL Item
Once a week (30)
CL Item
TID (31)
CL Item
Unknown (32)
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra-arterial (3)
CL Item
Intra-articular (4)
CL Item
Intra-bursa (5)
CL Item
Intradermal (6)
CL Item
Inhalation (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenous (17)
CL Item
Nasogastric (18)
CL Item
Nasal (19)
CL Item
Right eye (20)
CL Item
Ophthalmic (21)
CL Item
Left eye (22)
CL Item
Otic (23)
CL Item
Other (24)
CL Item
Both eyes (25)
CL Item
Oral (26)
CL Item
Rectal (27)
CL Item
Subcutaneous (28)
CL Item
Sublingual (29)
CL Item
Transdermal (30)
CL Item
Topical (31)
CL Item
Unknown (32)
CL Item
Vaginal (33)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medication Start Date and Time
Item
Medication Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Medication taken Prior to Study?
Item
Medication taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant medication ongoing?
Item
Concomitant medication ongoing?
boolean
C2826666 (UMLS CUI [1])
End date and time of concomitant medication
Item
End date and time of concomitant medication
datetime
C2826744 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
C1522314 (UMLS CUI [2])
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
CL Item
Haematology (H)
CL Item
Clinical Chemistry (C)
Date and time sample taken
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item Group
Electronically Transferred Steroid Hormone Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0301818 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
C0022885 (UMLS CUI-2)
C0301818 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
CL Item
Clinical Chemistry (C)
CL Item
Urinalysis (U)
Date and time sample taken
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Vital Signs Actual date/time
Item
Vital Signs Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
CL Item
Not done (1)
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
CL Item
Not done (1)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
CL Item
Not done (1)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])