ID

41977

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

Keywords

  1. 3/11/21 3/11/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 11, 2021

DOI

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License

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 - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection

Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication - Sequence Number
Description

Concomitant Medication - Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Concomitant Medication - Drug Name
Description

Trade Name preferred

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Concomitant Medication - Modified reported term
Description

Concomitant Medication - Modified reported term

Data type

text

Alias
UMLS CUI [1]
C2826819
Concomitant Medication - GSK Drug synonym
Description

Concomitant Medication - GSK Drug synonym

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0871468
Concomitant Medication GSK Drug Collection code
Description

Concomitant Medication GSK Drug Collection code

Data type

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1516698
UMLS CUI [2,3]
C0805701
Concomitant Medication - Failed coding
Description

Concomitant Medication - Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Concomitant Medication - Unit Dose
Description

Concomitant Medication - Unit Dose

Data type

text

Alias
UMLS CUI [1]
C2826646
Concomitant Medication - Units
Description

Concomitant Medication - Units

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Concomitant Medication - Frequency
Description

Concomitant Medication - Frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Concomitant Medication - Route
Description

Concomitant Medication - Route

Data type

text

Alias
UMLS CUI [1]
C2826730
Concomitant Medication - Reason for Medication
Description

Concomitant Medication - Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication - Start Date and Time
Description

Concomitant Medication - Start Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C2347852
Concomitant Medication - Taken Prior to Study?
Description

Concomitant Medication - Taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant Medication - Ongoing?
Description

Concomitant Medication - Ongoing?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Concomitant Medication - End Date and Time
Description

Concomitant Medication - End Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1522314
12-Lead ECG/ Holter/ Telemetry ECG
Description

12-Lead ECG/ Holter/ Telemetry ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0013801
UMLS CUI-3
C1623258
UMLS CUI-4
C0039451
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
ECG - Heart rate
Description

ECG - Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
ECG - PR Interval
Description

ECG - PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
ECG - QRS Duration
Description

ECG - QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
ms
ECG - Uncorrected QT Interval
Description

ECG - Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
ms
ECG - QTc Interval
Description

ECG - QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
ms
ECG - Method of QTc Calculation
Description

ECG - Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
ECG Abnormalities
Description

ECG Abnormalities

Alias
UMLS CUI-1
C0522055
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
A. Rhythm
Description

A. Rhythm

Data type

text

Alias
UMLS CUI [1]
C0232187
Other abnormal rhythm, enter comment
Description

Other abnormal rhythm, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611
B. P-Wave Morphology
Description

B. P-Wave Morphology

Data type

text

Alias
UMLS CUI [1]
C2216025
Other morphology, enter comment
Description

Other morphology, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0430456
UMLS CUI [1,3]
C1704258
UMLS CUI [2,1]
C0947611
UMLS CUI [2,2]
C0205394
C. Conduction
Description

C. Conduction

Data type

text

Alias
UMLS CUI [1]
C0232217
Other conduction, enter comment
Description

Other conduction, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C0205394
D. Myocardial Infarction
Description

D. Myocardial Infarction

Data type

text

Alias
UMLS CUI [1]
C0027051
Other myocardial infarction, enter comment
Description

Other myocardial infarction, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
E. Depolarisation/Repolarisation (QRS-T)
Description

E. Depolarisation/Repolarisation (QRS-T)

Data type

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0948857
Other depolarisation/repolarisation, enter comment
Description

Other depolarisation/repolarisation, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0948857
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C0947611
Other abnormalities
Description

Other abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
Other abnormalities, enter comment
Description

Other abnormalities, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Actual date/time
Description

Vital Signs - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic Blood pressure
Description

Systolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Description

Diastolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart rate
Description

Vital Signs - Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Local Laboratory
Description

Local Laboratory

Alias
UMLS CUI-1
C0022885
Haematology - Date and time sample taken
Description

Haematology - Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1]
C0018941
UMLS CUI [2]
C0870078
UMLS CUI [3]
C0011008
UMLS CUI [4]
C0040223
Haematology - Has the subject fasted?
Description

Haematology - Has the subject fasted?

Data type

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0015663
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology Test
Description

Haematology Test

Data type

integer

Alias
UMLS CUI [1]
C0018941
Haematology - Numeric result
Description

Haematology - Numeric result

Data type

float

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2347373
Haematology - Character result
Description

Haematology - Character result

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2350015
Haematology - No result
Description

Haematology - No result

Data type

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clinical Chemistry Test
Description

Clinical Chemistry Test

Data type

integer

Alias
UMLS CUI [1]
C0525044
Clinical Chemistry - Numeric result
Description

Clinical Chemistry - Numeric result

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2347373
Clinical Chemistry - Character result
Description

Clinical Chemistry - Character result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Clinical Chemistry - No result
Description

Clinical Chemistry - No result

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
Urinalysis - Local
Description

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Urinalysis - Date and time sample taken
Description

Urinalysis - Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Result of dipstick
Description

Result of dipstick

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Was sedimentary microscopy performed?
Description

If yes, provide details on the MICROSCOPY form

Data type

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Urinalysis - Local: Dipstick Details
Description

Urinalysis - Local: Dipstick Details

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0022885
Dipstick Test
Description

Dipstick Test

Data type

integer

Alias
UMLS CUI [1]
C0430370
Dipstick - Numeric result
Description

Dipstick - Numeric result

Data type

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C2347373
Dipstick - Character result
Description

Dipstick - Character result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C2350015
Dipstick - No result
Description

Dipstick - No result

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Urinalysis - Local: Microscopy Details
Description

Urinalysis - Local: Microscopy Details

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C0042014
Microscopy Test
Description

Microscopy Test

Data type

integer

Alias
UMLS CUI [1]
C0430397
Microscopy - Numeric result
Description

Microscopy - Numeric result

Data type

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2347373
Microscopy - Character result
Description

Microscopy - Character result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2350015
Microscopy - No result
Description

Microscopy - No result

Data type

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0456984
Pulmonary Function Tests
Description

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Date/time of test
Description

Date/time of test

Data type

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV1 - 1 (3 readings)
Description

FEV1 - 1 (3 readings)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 - 2 (3 readings)
Description

FEV1 - 2 (3 readings)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 - 3 (3 readings)
Description

FEV1 - 3 (3 readings)

Data type

integer

Measurement units
  • L
Alias
UMLS CUI [1]
C0748133
L
Nasal Airflow Resistance
Description

Nasal Airflow Resistance

Alias
UMLS CUI-1
C0028429
UMLS CUI-2
C0199498
Date and time of assessment
Description

Date and time of assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Nasal Airflow Resistance - Left Nostril (150Pa)
Description

Nasal Airflow Resistance - Left Nostril (150Pa)

Data type

text

Alias
UMLS CUI [1,1]
C0028429
UMLS CUI [1,2]
C0199498
UMLS CUI [1,3]
C1720438
Nasal Airflow Resistance - Right Nostril (150Pa)
Description

Nasal Airflow Resistance - Right Nostril (150Pa)

Data type

text

Alias
UMLS CUI [1,1]
C0028429
UMLS CUI [1,2]
C0199498
UMLS CUI [1,3]
C1720679
Nasal Inspection
Description

Nasal Inspection

Alias
UMLS CUI-1
C0558826
Date/time of Assessment
Description

Date/time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Left Nostril Colour
Description

Left Nostril Colour

Data type

text

Alias
UMLS CUI [1,1]
C0475705
UMLS CUI [1,2]
C1720438
Right Nostril colour
Description

Right Nostril colour

Data type

text

Alias
UMLS CUI [1,1]
C0475705
UMLS CUI [1,2]
C1720679
Left nostril concha media turbinate Swelling
Description

Left nostril concha media turbinate Swelling

Data type

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0205098
UMLS CUI [1,3]
C1720438
UMLS CUI [1,4]
C0038999
Left nostril concha inferior turbinate swelling
Description

Left nostril concha inferior turbinate swelling

Data type

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0542339
UMLS CUI [1,3]
C1720438
UMLS CUI [1,4]
C0038999
Right nostril concha media turbinate swelling
Description

Right nostril concha media turbinate swelling

Data type

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0205098
UMLS CUI [1,3]
C1720679
UMLS CUI [1,4]
C0038999
Right nostril concha inferior turbinate swelling
Description

Right nostril concha inferior turbinate swelling

Data type

text

Alias
UMLS CUI [1,1]
C1266928
UMLS CUI [1,2]
C0542339
UMLS CUI [1,3]
C1720679
UMLS CUI [1,4]
C0038999
Left nostril secretions
Description

Left nostril secretions

Data type

text

Alias
UMLS CUI [1,1]
C1720438
UMLS CUI [1,2]
C0036537
Right nostril secretions
Description

Right nostril secretions

Data type

text

Alias
UMLS CUI [1,1]
C1720679
UMLS CUI [1,2]
C0036537
Nasal Infection
Description

Nasal Infection

Data type

text

Alias
UMLS CUI [1]
C0555970
Post Nasal Drip
Description

Post Nasal Drip

Data type

text

Alias
UMLS CUI [1]
C0032781
Crusting
Description

Crusting

Data type

text

Alias
UMLS CUI [1]
C0205204

Similar models

Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication - Sequence Number
Item
Concomitant Medication - Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication - Drug Name
Item
Concomitant Medication - Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication - Modified reported term
Item
Concomitant Medication - Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medication - GSK Drug synonym
Item
Concomitant Medication - GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Concomitant Medication GSK Drug Collection code
Item
Concomitant Medication GSK Drug Collection code
text
C2347852 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1516698 (UMLS CUI [2,2])
C0805701 (UMLS CUI [2,3])
Concomitant Medication - Failed coding
Item
Concomitant Medication - Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Medication - Unit Dose
Item
Concomitant Medication - Unit Dose
text
C2826646 (UMLS CUI [1])
Item
Concomitant Medication - Units
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Code List
Concomitant Medication - Units
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (APP)
CL Item
Area under curve (AUC)
CL Item
Bottle (BOT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Cup (CUP)
CL Item
Gamma per kilogram per minute (GA/KGMIN)
CL Item
Gram (G)
CL Item
Drops (GTT)
CL Item
100 International units/ml (100IU/ML)
CL Item
Inhalation (INH)
CL Item
International units (IU)
CL Item
International units per kilogram (IU/KG)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre (IU/ML)
CL Item
Litre (L)
CL Item
Lozenge (LOZ)
CL Item
Litre per minute (L/MIN)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Microgram (MCG)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram/kilogram (MCG/KG)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Micrograms per millilitre (MCG/ML)
CL Item
Microlitre (MCL)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalent per 24 hours (MEQ/24HR)
CL Item
Milligram (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour (MG/HR)
CL Item
Milligram/kilogram (MG/KG)
CL Item
Milligram/kilogram per hour (MG/KG/HR)
CL Item
Milligram/kilogram per minute (MG/KG/MIN)
CL Item
Milligram/metre squared (KG/M2)
CL Item
Milligram/millilitre (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Million international units (MIU)
CL Item
Millilitre (ML)
CL Item
Millilitre per hour (ML/HR)
CL Item
Millilitre per minute (ML/MIN)
CL Item
Millimole (MMOL)
CL Item
Megaunits (million units) (MU)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Sachet (SACH)
CL Item
Spray (SPR)
CL Item
Suppository (SUPP)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Microgram (UG) (UG)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Units (U)
CL Item
Unknown (UNK)
CL Item
Vial (VIAL)
Item
Concomitant Medication - Frequency
text
C2826654 (UMLS CUI [1])
Code List
Concomitant Medication - Frequency
CL Item
2 times per week (2XWK)
CL Item
3 times per week (3XWK)
CL Item
4 times per week (4XWK)
CL Item
5 times per day (5XD)
CL Item
5 times per week (5XWK)
CL Item
AC (AC)
CL Item
BID (BID)
CL Item
Continuous infusion (CINF)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Q2H (Q2H)
CL Item
Every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 months (Q3M)
CL Item
Every 3 weeks (Q3WK)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QH (QH)
CL Item
QID (QID)
CL Item
Once a month (QM)
CL Item
Every other day (QOD)
CL Item
QPM (QPM)
CL Item
Once a week (QWK)
CL Item
TID (TID)
CL Item
Unknown (UNK)
Item
Concomitant Medication - Route
text
C2826730 (UMLS CUI [1])
Code List
Concomitant Medication - Route
CL Item
Epidural (EP)
CL Item
Gastrostomy tube (GTT)
CL Item
Intra-arterial (IA)
CL Item
Intra-articular (IART)
CL Item
Inta-bursa (IB)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intralesional (ILES)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Intraoccular (IO)
CL Item
Intraosteal (IOS)
CL Item
Intraperitoneal (IP)
CL Item
Intrathecal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous (IV)
CL Item
Nasogastric (NG)
CL Item
Nasal (NS)
CL Item
Right eye (OD)
CL Item
Ophthalmic (OP)
CL Item
Left eye (OS)
CL Item
Otic (OT)
CL Item
Other (OTH)
CL Item
Both eyes (OU)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
CL Item
Vaginal (VG)
Concomitant Medication - Reason for Medication
Item
Concomitant Medication - Reason for Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication - Start Date and Time
Item
Concomitant Medication - Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Concomitant Medication - Taken Prior to Study?
Item
Concomitant Medication - Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication - Ongoing?
Item
Concomitant Medication - Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication - End Date and Time
Item
Concomitant Medication - End Date and Time
datetime
C2826744 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item Group
12-Lead ECG/ Holter/ Telemetry ECG
C0430456 (UMLS CUI-1)
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
ECG - Heart rate
Item
ECG - Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
ECG - PR Interval
Item
ECG - PR Interval
integer
C0429087 (UMLS CUI [1])
ECG - QRS Duration
Item
ECG - QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
ECG - Uncorrected QT Interval
Item
ECG - Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
ECG - QTc Interval
Item
ECG - QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
ECG - Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
ECG - Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
ECG Abnormalities
C0522055 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
A. Rhythm
text
C0232187 (UMLS CUI [1])
Code List
A. Rhythm
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40 - 50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30 - 39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering artrial pacemaker (A17)
CL Item
Multifocal artrial tachycardia (wandering artrial pacemaker w/rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (A6)
CL Item
Artrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate <= 100 beats/min) (A5)
CL Item
Junctional rhythm (A25)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
Idioventricular rhythm (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A32)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial PAcemaker (A16)
CL Item
Other abnormal rhythm, enter comment (A99)
Other abnormal rhythm, enter comment
Item
Other abnormal rhythm, enter comment
text
C0232187 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item
B. P-Wave Morphology
text
C2216025 (UMLS CUI [1])
Code List
B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology, enter comment (B99)
Other morphology, enter comment
Item
Other morphology, enter comment
text
C0332437 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Item
C. Conduction
text
C0232217 (UMLS CUI [1])
Code List
C. Conduction
CL Item
First degree AV block (PR interval >20 msec) (C1)
CL Item
Short PR interval (C20)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior or hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (C10)
CL Item
Accessory pathway (Wolff-PArkinson White, Lown Ganong-Levine) (C11)
CL Item
Prolonged QT interval (C19)
CL Item
QT/QTc prolongation >= 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction, enter comment (C99)
Other conduction, enter comment
Item
Other conduction, enter comment
text
C0232217 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
D. Myocardial Infarction
text
C0027051 (UMLS CUI [1])
Code List
D. Myocardial Infarction
CL Item
Myocardial infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non Q-wave (D20)
CL Item
Other myocardial infarction, enter comment (D98)
Other myocardial infarction, enter comment
Item
Other myocardial infarction, enter comment
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
C1331539 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
Code List
E. Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST-elevation - pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flatening/inversion (D17)
CL Item
Other depolarisation/repolarisation, enter comment (D99)
Other depolarisation/repolarisation, enter comment
Item
Other depolarisation/repolarisation, enter comment
text
C1331539 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0205394 (UMLS CUI [3,1])
C0947611 (UMLS CUI [3,2])
Item
Other abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Other abnormalities
CL Item
Other abnormalities, enter comment (E99)
Other abnormalities, enter comment
Item
Other abnormalities, enter comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Local Laboratory
C0022885 (UMLS CUI-1)
Haematology - Date and time sample taken
Item
Haematology - Date and time sample taken
datetime
C0018941 (UMLS CUI [1])
C0870078 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
C0040223 (UMLS CUI [4])
Haematology - Has the subject fasted?
Item
Haematology - Has the subject fasted?
boolean
C0018941 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Code List
Haematology Test
CL Item
Basophils (1)
CL Item
Eosinophils (2)
CL Item
Haemoglobin (3)
CL Item
Haematocrit (4)
CL Item
Lymphocytes (5)
CL Item
MCH (6)
CL Item
MCHC (7)
CL Item
MCV (8)
CL Item
Monocytes (9)
CL Item
Neutrophils (10)
CL Item
Platelets (11)
CL Item
Reticulocytes (12)
CL Item
RBC (13)
CL Item
WBC (14)
Haematology - Numeric result
Item
Haematology - Numeric result
float
C0474523 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Haematology - Character result
Item
Haematology - Character result
text
C0474523 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Haematology - No result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Haematology - No result
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Code List
Clinical Chemistry Test
CL Item
Albumin (1)
CL Item
Alkaline Phosphatase (2)
CL Item
ALT (3)
CL Item
AST (4)
CL Item
Calcium (5)
CL Item
Chloride (6)
CL Item
Creatinine (7)
CL Item
Direct Bilirubin (8)
CL Item
GGT (9)
CL Item
Glucose (10)
CL Item
Potassium (11)
CL Item
Sodium (12)
CL Item
Total Bilirubin (13)
CL Item
Total Protein (14)
CL Item
Urea (15)
CL Item
Uric Acid (16)
Clinical Chemistry - Numeric result
Item
Clinical Chemistry - Numeric result
float
C0008000 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Clinical Chemistry - Character result
Item
Clinical Chemistry - Character result
text
C0008000 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Clinical Chemistry - No result
integer
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Code List
Clinical Chemistry - No result
CL Item
No result (1)
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
Urinalysis - Date and time sample taken
Item
Urinalysis - Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of dipstick
CL Item
No result (NR)
CL Item
Negative (NEG)
CL Item
Positive (POS)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Item
Dipstick Test
integer
C0430370 (UMLS CUI [1])
Code List
Dipstick Test
CL Item
Protein (1)
CL Item
Glucose (2)
CL Item
Ketones (3)
CL Item
Bilirubin (4)
CL Item
Blood (5)
CL Item
Urobilinogen (6)
CL Item
Leucocytes (7)
CL Item
Specific Gravity (8)
Dipstick - Numeric result
Item
Dipstick - Numeric result
float
C0430370 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Dipstick - Character result
Item
Dipstick - Character result
text
C0430370 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Dipstick - No result
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Dipstick - No result
CL Item
No result (1)
Item Group
Urinalysis - Local: Microscopy Details
C0430397 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Item
Microscopy Test
integer
C0430397 (UMLS CUI [1])
Code List
Microscopy Test
CL Item
White blood cells (1)
CL Item
Red blood cells (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Microscopy - Numeric result
Item
Microscopy - Numeric result
float
C0430397 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Microscopy - Character result
Item
Microscopy - Character result
text
C0430397 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Microscopy - No result
integer
C0430397 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Microscopy - No result
CL Item
No result (1)
Item Group
Pulmonary Function Tests
C0024119 (UMLS CUI-1)
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 - 1 (3 readings)
Item
FEV1 - 1 (3 readings)
integer
C0748133 (UMLS CUI [1])
FEV1 - 2 (3 readings)
Item
FEV1 - 2 (3 readings)
integer
C0748133 (UMLS CUI [1])
FEV1 - 3 (3 readings)
Item
FEV1 - 3 (3 readings)
integer
C0748133 (UMLS CUI [1])
Item Group
Nasal Airflow Resistance
C0028429 (UMLS CUI-1)
C0199498 (UMLS CUI-2)
Date and time of assessment
Item
Date and time of assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Nasal Airflow Resistance - Left Nostril (150Pa)
Item
Nasal Airflow Resistance - Left Nostril (150Pa)
text
C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
Nasal Airflow Resistance - Right Nostril (150Pa)
Item
Nasal Airflow Resistance - Right Nostril (150Pa)
text
C0028429 (UMLS CUI [1,1])
C0199498 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
Item Group
Nasal Inspection
C0558826 (UMLS CUI-1)
Date/time of Assessment
Item
Date/time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Left Nostril Colour
text
C0475705 (UMLS CUI [1,1])
C1720438 (UMLS CUI [1,2])
Code List
Left Nostril Colour
CL Item
Normal (N)
CL Item
Abnormal; Specify colour (A)
CL Item
Red (R)
CL Item
Blue (B)
CL Item
White (W)
Item
Right Nostril colour
text
C0475705 (UMLS CUI [1,1])
C1720679 (UMLS CUI [1,2])
Code List
Right Nostril colour
CL Item
Normal (N)
CL Item
Abnormal (A)
CL Item
Red (R)
CL Item
Blue (B)
CL Item
White (W)
Item
Left nostril concha media turbinate Swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Code List
Left nostril concha media turbinate Swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Left nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Code List
Left nostril concha inferior turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Right nostril concha media turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Code List
Right nostril concha media turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Right nostril concha inferior turbinate swelling
text
C1266928 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
Code List
Right nostril concha inferior turbinate swelling
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)
Item
Left nostril secretions
text
C1720438 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
Code List
Left nostril secretions
CL Item
Absent (A)
CL Item
Present; specify colour (P)
CL Item
Clear (CL)
CL Item
Opaque (OP)
CL Item
Purulent (PR)
Item
Right nostril secretions
text
C1720679 (UMLS CUI [1,1])
C0036537 (UMLS CUI [1,2])
Code List
Right nostril secretions
CL Item
Absent (A)
CL Item
Present; specify colour (P)
CL Item
Clear (CL)
CL Item
Opaque (OP)
CL Item
Purulent (PR)
Item
Nasal Infection
text
C0555970 (UMLS CUI [1])
Code List
Nasal Infection
CL Item
No infection (N)
CL Item
Viral infection (V)
CL Item
Bacterial infection (B)
Item
Post Nasal Drip
text
C0032781 (UMLS CUI [1])
Code List
Post Nasal Drip
CL Item
Absent (A)
CL Item
Present; specify colour (P)
CL Item
Clear (CL)
CL Item
Opaque (OP)
CL Item
Purulent (PR)
Item
Crusting
text
C0205204 (UMLS CUI [1])
Code List
Crusting
CL Item
Absent (A)
CL Item
Mild (M)
CL Item
Severe (S)

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