ID

32870

Description

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Keywords

Versions (1)
  1. 11/17/18 11/17/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 17, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138

English

Concomitant Medications, Asthma Exacerbations, IP Device Malfunction, Chest X-Ray, Pharmacogenetic Research Consent/ Sample Collection, Investigational Product Compliance and Unsceduled Asthma related Healthcare Resource Utilisation - Subject Logs

1 forms  
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Drug name (trade name preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C0592503
Unit dose
Description

Unit dose

Data type

text

Alias
UMLS CUI [1]
C2826646
Drug dose unit
Description

Drug dose unit

Data type

integer

Alias
UMLS CUI [1]
C2826646
Drug Frequency
Description

Drug Frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Medication Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Generic dispensed?
Description

Generic dispensed?

Data type

boolean

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

Prescription or OTC

Data type

integer

Alias
UMLS CUI [1,1]
C3166216
UMLS CUI [1,2]
C0013231
Concomitant Medication Start Date
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medication taken prior to study?
Description

Concomitant Medication taken prior to study?

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C1883727
UMLS CUI [1,4]
C0332152
Concomitant Medication ongoing?
Description

Concomitant Medication ongoing?

Data type

text

Alias
UMLS CUI [1]
C2826666
If Concomitant Medication is not ongoing, specify End Date.
Description

Concomitant Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Device Used to Administer Medication
Description

Device Used to Administer Medication

Data type

text

Alias
UMLS CUI [1,1]
C0699733
UMLS CUI [1,2]
C0806914
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Was drug administered as a rescue medication?
Description

Was drug administered as a rescue medication?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
Cumulative Dose Used?
Description

Cumulative Dose Used?

Data type

text

Alias
UMLS CUI [1]
C2986497
Was drug ever used?
Description

Was drug ever used?

Data type

boolean

Alias
UMLS CUI [1]
C0242510
Concomitant Medication Total Duration
Description

Concomitant Medication Total Duration

Data type

float

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0449238
Concomitant Medication Duration Unit
Description

Concomitant Medication Duration Unit

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0439148
Medication Type
Description

Medication Type

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
Asthma Exacerbations
Description

Asthma Exacerbations

Alias
UMLS CUI-1
C0349790
Date of Onset
Description

Date of Onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1547647
If Outcome is "Resolved", provide End Date.
Description

If Outcome is "Resolved", provide End Date

Data type

date

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C3714811
UMLS CUI [1,3]
C0806020
If Outcome is fatal, record Date of Death.
Description

If Outcome is fatal, record Date of Death

Data type

date

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C1148348
Severity of Asthma Exacerbation
Description

Severity of Asthma Exacerbation

Data type

integer

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0439793
Was the subject withdrawn due to this exacerbation?
Description

Was the subject withdrawn due to this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0349790
UMLS CUI [1,3]
C0678226
Primary cause of Exacerbation
Description

Primary cause of Exacerbation

Data type

integer

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0085978
Were systemic/ oral corticosteroids taken for the exacerbation?
Description

Were systemic/ oral corticosteroids taken for the exacerbation?

Data type

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C0574135
UMLS CUI [3]
C0349790
Were antibiotics taken for the exacerbation?
Description

Were antibiotics taken for the exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0349790
Was a medication taken for this exacerbation?
Description

Was a medication taken for this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C1290952
UMLS CUI [1,2]
C0349790
Was the subject hospitalised for this exacerbation?
Description

Was the subject hospitalised for this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0019993
Did the subject visit the emergency room due to this exacerbation?
Description

Did the subject visit the emergency room due to this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0583237
Was the subject intubated for this exacerbation?
Description

Was the subject intubated for this exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0021925
Was rescue medication use increased due to the exacerbation?
Description

Was rescue medication use increased due to the exacerbation?

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0884980
UMLS CUI [1,4]
C0442805
Was an x-ray performed?
Description

Was an x-ray performed?

Data type

boolean

Alias
UMLS CUI [1]
C1306645
Contact Method/ Treatment site for Exacerbations
Description

Contact Method/ Treatment site for Exacerbations

Alias
UMLS CUI-1
C0332158
UMLS CUI-2
C0025663
UMLS CUI-4
C0337950
UMLS CUI-5
C0349790
Number of telephone calls
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0449788
Number of home visits
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
Number of physician office/ practice visits
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0031834
UMLS CUI [1,3]
C0449788
Number of urgent care/ outpatient clinic visits
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C1551285
UMLS CUI [1,2]
C0029921
UMLS CUI [1,3]
C0008952
UMLS CUI [1,4]
C0449788
Number of emergency room visits
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C2114437
UMLS CUI [1,2]
C0449788
Number of intpatient hospitalisation days
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0420496
UMLS CUI [1,2]
C0439228
Exacerbation Medications
Description

Exacerbation Medications

Alias
UMLS CUI-1
C0349790
UMLS CUI-2
C0013227
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Drug name
Description

Trade name preferred.

Data type

text

Alias
UMLS CUI [1]
C2360065
Drug Unit dose
Description

Drug Unit dose

Data type

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0869039
Drug Units
Description

Drug Units

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0439148
Drug Frequency
Description

Drug Frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Medication Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Drug Start Date
Description

Drug Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Drug taken prior to study?
Description

Drug taken prior to study?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0332152
Is Medication ongoing?
Description

Is Medication ongoing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
If Medication is not ongoing, speciffy End Date.
Description

Medication End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication type
Description

Medication type

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
IP Device Malfunction
Description

IP Device Malfunction

Alias
UMLS CUI-1
C1881681
Investigational product container number
Description

Investigational product container number

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Mark all applicate reasons for device malfunction
Description

Mark all applicate reasons for device malfunction

Data type

integer

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0392360
If other reasons for device malfunction, specify.
Description

If other reasons for device malfunction, specify

Data type

text

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Chest X-Ray
Description

Chest X-Ray

Alias
UMLS CUI-1
C0039985
Date of x-ray
Description

Date of x-ray

Data type

date

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0011008
Were findings consistent with a diagnosis of pneumonia?
Description

Diagnosis of pneumonia

Data type

boolean

Alias
UMLS CUI [1]
C0221566
UMLS CUI [2]
C0032285
Pharmacogenetic (PGx) Research Consent/ Sample Collection
Description

Pharmacogenetic (PGx) Research Consent/ Sample Collection

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C0035168
UMLS CUI-4
C0200345
Has informed consent been obtained for PGx research?
Description

Has informed consent been obtained for PGx research?

Data type

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C0021430
If informed consent was obtained for PGx research, record date.
Description

Date informed consent was obtained

Data type

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0035168
UMLS CUI [2]
C2985782
If informed consent was obtained for PGx research, has sample been collected?
Description

Has sample for PGx been collected?

Data type

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0035168
UMLS CUI [2]
C2985782
UMLS CUI [3]
C0200345
If sample has been collected for PGx research, record date sample taken.
Description

Date sample taken for PGx research

Data type

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0035168
UMLS CUI [2]
C1302413
If informed consent was not obtained for PGx research, check reason
Description

Reason for informed consent not obtained

Data type

integer

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C1882120
UMLS CUI [2]
C0392360
If other reason for informed consent not beeing obtained for PGx research, specify.
Description

Other reason for informed consent not beeing obtained

Data type

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C1882120
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Investigational Product Compliance
Description

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Investigational product container number
Description

Investigational product container number

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Visit Investigational Product Dispensed
Description

Visit Investigational Product Dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0947323
UMLS CUI [1,3]
C0545082
Date Investigational Product Dispensed
Description

Date Investigational Product Dispensed

Data type

date

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0011008
Start Date Investigational Product
Description

Start Date Investigational Product

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Dose Counter Start
Description

Dose Counter Start

Data type

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0439659
Visit Investigational Product Returned
Description

Visit Investigational Product Returned

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0545082
Date Investigational Product Returned
Description

Date Investigational Product Returned

Data type

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2826249
End Date Investigational Product
Description

End Date Investigational Product

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Dose Counter Stop
Description

Dose Counter Stop

Data type

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C2746065
Unscheduled Asthma related Healthcare Resource Utilisation
Description

Unscheduled Asthma related Healthcare Resource Utilisation

Alias
UMLS CUI-1
C1704738
UMLS CUI-2
C3854240
UMLS CUI-3
C0004096
Date of contact
Description

Date of contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Number of home visits (day)
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0439228
Number of home visits (night)
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0020043
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0240526
Number of physician office/ practice visits
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0031834
UMLS CUI [1,3]
C0449788
Number of urgent care/ outpatient clinic visits
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C1551285
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0029921
UMLS CUI [1,4]
C0449788
Number of emergency room visits
Description

If non, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C2114437
UMLS CUI [1,2]
C0449788
Number of inpatient hospitalisation days - ICU
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0420496
UMLS CUI [1,2]
C0021708
UMLS CUI [1,3]
C0439228
Number of inpatient hospitalisation days - General ward
Description

If none, enter 0.

Data type

integer

Alias
UMLS CUI [1,1]
C0420496
UMLS CUI [1,2]
C0043030
UMLS CUI [1,3]
C0439228
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Similar models

Concomitant Medications, Asthma Exacerbations, IP Device Malfunction, Chest X-Ray, Pharmacogenetic Research Consent/ Sample Collection, Investigational Product Compliance and Unsceduled Asthma related Healthcare Resource Utilisation - Subject Logs

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name (trade name preferred)
text
C2360065 (UMLS CUI [1])
C0592503 (UMLS CUI [2])
Unit dose
Item
Unit dose
text
C2826646 (UMLS CUI [1])
Item
Drug dose unit
integer
C2826646 (UMLS CUI [1])
Drug dose unit
Code List
Drug dose unit
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
FInger tip unit (9)
CL Item
Gamma per kilogram per minute (10)
CL Item
Gram (11)
CL Item
Grams per kilogram (12)
CL Item
Grams per litre (13)
CL Item
Grams per metre squared (14)
CL Item
Grams per metre squared per 12 hours (15)
CL Item
Grams per metre squared per day (16)
CL Item
Grams per mililitre (17)
CL Item
Inhalation (18)
CL Item
100 International units/ml (19)
CL Item
International units (20)
CL Item
International units per kilogram (21)
CL Item
International units per kilogram per hour (22)
CL Item
International units per mililitre (23)
CL Item
Litre (24)
CL Item
Litre per minute (25)
CL Item
Lozenge (26)
CL Item
Mega becquerels (MBq) (27)
CL Item
Megaunits (million units) (28)
CL Item
Microgram (MCG) (29)
CL Item
Microgram (UG) (30)
CL Item
Micrograms per gram (31)
CL Item
Micrograms per hour (32)
CL Item
Microgram/kilogram (33)
CL Item
Microgram/kilogram per minute (34)
CL Item
Micrograms per mililitre (35)
CL Item
Micrograms per minute (36)
CL Item
Microlitre (37)
CL Item
Micromoles (38)
CL Item
Micromoles per 24 hours (39)
CL Item
Milicurie (40)
CL Item
Milliequivalent (41)
CL Item
Milliequivalent per 24 hours (42)
CL Item
Milligram (43)
CL Item
Miligram per day (44)
CL Item
Miligram per hour (45)
CL Item
Milligram/kilogram (46)
CL Item
Milligram/kilogram per hour (47)
CL Item
Milligram/kilogram per minute (48)
CL Item
Milligram/metre squared (49)
CL Item
Miligrams per metre squared per day (50)
CL Item
Milligram/millilitre (51)
CL Item
Miligram per week (52)
CL Item
Milligrams percent (53)
CL Item
Millilitre (54)
CL Item
Millilitre per hour (55)
CL Item
Millilitre per minute (56)
CL Item
Millimole (57)
CL Item
Milimoles per kilogram (58)
CL Item
Milimoles per mililitre (59)
CL Item
Million international units (60)
CL Item
Minimum alveolar concentration (61)
CL Item
Nanogram per kilogram per minute (62)
CL Item
Nebule (63)
CL Item
Ounce (64)
CL Item
Pack (65)
CL Item
Patch (66)
CL Item
Percent (67)
CL Item
Puff (68)
CL Item
Ring (69)
CL Item
Sachet (70)
CL Item
Spray (71)
CL Item
Suppository (72)
CL Item
Tablespoon (73)
CL Item
Tablet (74)
CL Item
Teaspoon (75)
CL Item
Units (76)
CL Item
Units per gram (77)
CL Item
Units per hour (78)
CL Item
Units per kilogram per minute (79)
CL Item
Units per minute (80)
CL Item
Unknown (81)
CL Item
Vial (82)
Item
Drug Frequency
integer
C3476109 (UMLS CUI [1])
Drug Frequency
Code List
Drug Frequency
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 clay (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
PRN (12)
CL Item
Q12H (13)
CL Item
Q2H (14)
CL Item
Every 2 weeks (15)
CL Item
Q3D (16)
CL Item
Every 3 months (17)
CL Item
Every 3 weeks (18)
CL Item
Q4D (19)
CL Item
Q4H (20)
CL Item
Q6H (21)
CL Item
Q8H (22)
CL Item
QAM (23)
CL Item
QH (24)
CL Item
QID (25)
CL Item
Once a month (26)
CL Item
Every other day (27)
CL Item
QPM (28)
CL Item
Once a week (29)
CL Item
TID (30)
CL Item
Unknown (31)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
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
lntramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intra thecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenous (17)
CL Item
Jejunostomy feeding tube (JEJ or PEJ) (18)
CL Item
Nasogastric (19)
CL Item
Nasal (20)
CL Item
Right eye (21)
CL Item
Ophthalmic (22)
CL Item
Left eye (23)
CL Item
Otic (24)
CL Item
Other (25)
CL Item
Both eyes (26)
CL Item
Oral (27)
CL Item
Rectal (28)
CL Item
Subcutaneous (29)
CL Item
Sublingual (30)
CL Item
Transdermal (31)
CL Item
Transmucosal (32)
CL Item
Topical (33)
CL Item
Unknown (34)
CL Item
Vaginal (35)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Generic dispensed?
Item
Generic dispensed?
boolean
C3242750 (UMLS CUI [1])
Item
Prescription or OTC?
integer
C3166216 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
undefined item
Code List
Prescription or OTC?
CL Item
Presciption (1)
CL Item
OTC (2)
Concomitant Medication Start Date
Item
Concomitant Medication Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication taken prior to study?
Item
Concomitant Medication taken prior to study?
boolean
C2347852 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Item
Concomitant Medication ongoing?
text
C2826666 (UMLS CUI [1])
Concomitant Medication ongoing?
Code List
Concomitant Medication ongoing?
CL Item
Yes (Y)
CL Item
No, specify End Date (N)
Concomitant Medication End Date
Item
If Concomitant Medication is not ongoing, specify End Date.
date
C2826744 (UMLS CUI [1])
Device Used to Administer Medication
Item
Device Used to Administer Medication
text
C0699733 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Was drug administered as a rescue medication?
Item
Was drug administered as a rescue medication?
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Cumulative Dose Used?
Item
Cumulative Dose Used?
text
C2986497 (UMLS CUI [1])
Was drug ever used?
Item
Was drug ever used?
boolean
C0242510 (UMLS CUI [1])
Concomitant Medication Total Duration
Item
Concomitant Medication Total Duration
float
C2347852 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Concomitant Medication Duration Unit
integer
C2347852 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Concomitant Medication Duration Unit
Code List
Concomitant Medication Duration Unit
CL Item
Days (1)
CL Item
Months (2)
CL Item
Weeks (3)
CL Item
Years (4)
Item
Medication Type
integer
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Medication Type
Code List
Medication Type
CL Item
Non- Asthma (1)
CL Item
Asthma (2)
Item Group
Asthma Exacerbations
C0349790 (UMLS CUI-1)
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Outcome
integer
C1547647 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved, provide End Date (1)
CL Item
Fatal, provide Date of Death (2)
CL Item
Not resolved (3)
If Outcome is "Resolved", provide End Date
Item
If Outcome is "Resolved", provide End Date.
date
C1547647 (UMLS CUI [1,1])
C3714811 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
If Outcome is fatal, record Date of Death
Item
If Outcome is fatal, record Date of Death.
date
C1547647 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,3])
Item
Severity of Asthma Exacerbation
integer
C0349790 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Severity of Asthma Exacerbation
Code List
Severity of Asthma Exacerbation
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Moderate/ Severe (4)
Was the subject withdrawn due to this exacerbation?
Item
Was the subject withdrawn due to this exacerbation?
boolean
C0422727 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
Item
Primary cause of Exacerbation
integer
C0349790 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Primary cause of Exacerbation
Code List
Primary cause of Exacerbation
CL Item
Cold air/ Cold weather (1)
CL Item
Tobacoo smoke (2)
CL Item
Upper respiratory infection (3)
CL Item
Air pollution (4)
CL Item
Allergy (5)
CL Item
Exercise (6)
CL Item
Stress/ Emotions (7)
CL Item
Beta- blockers (8)
CL Item
Aspirin (9)
CL Item
Other NSAIDS (10)
CL Item
Withholding or reducing asthma meds (11)
CL Item
Withholding or reducing COPD meds (12)
CL Item
Unknown etiology (13)
CL Item
Lack of efficacy (14)
CL Item
Lower respiratory infection (15)
CL Item
Common cold (16)
CL Item
Upper respiratory infection other than common cold (17)
CL Item
Other (18)
Were systemic/ oral corticosteroids taken for the exacerbation?
Item
Were systemic/ oral corticosteroids taken for the exacerbation?
boolean
C2825233 (UMLS CUI [1])
C0574135 (UMLS CUI [2])
C0349790 (UMLS CUI [3])
Were antibiotics taken for the exacerbation?
Item
Were antibiotics taken for the exacerbation?
boolean
C0003232 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
Was a medication taken for this exacerbation?
Item
Was a medication taken for this exacerbation?
boolean
C1290952 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
Was the subject hospitalised for this exacerbation?
Item
Was the subject hospitalised for this exacerbation?
boolean
C0349790 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Did the subject visit the emergency room due to this exacerbation?
Item
Did the subject visit the emergency room due to this exacerbation?
boolean
C0349790 (UMLS CUI [1,1])
C0583237 (UMLS CUI [1,2])
Was the subject intubated for this exacerbation?
Item
Was the subject intubated for this exacerbation?
boolean
C0349790 (UMLS CUI [1,1])
C0021925 (UMLS CUI [1,2])
Was rescue medication use increased due to the exacerbation?
Item
Was rescue medication use increased due to the exacerbation?
boolean
C0349790 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,3])
C0442805 (UMLS CUI [1,4])
Was an x-ray performed?
Item
Was an x-ray performed?
boolean
C1306645 (UMLS CUI [1])
Item Group
Contact Method/ Treatment site for Exacerbations
C0332158 (UMLS CUI-1)
C0025663 (UMLS CUI-2)
C0337950 (UMLS CUI-4)
C0349790 (UMLS CUI-5)
Number of telephone calls
Item
Number of telephone calls
integer
C0302186 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of home visits
Item
Number of home visits
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of physician office/ practice visits
Item
Number of physician office/ practice visits
integer
C0545082 (UMLS CUI [1,1])
C0031834 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of urgent care/ outpatient clinic visits
Item
Number of urgent care/ outpatient clinic visits
integer
C1551285 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,4])
Number of emergency room visits
Item
Number of emergency room visits
integer
C2114437 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of intpatient hospitalisation days
Item
Number of intpatient hospitalisation days
integer
C0420496 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Item Group
Exacerbation Medications
C0349790 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Drug Unit dose
Item
Drug Unit dose
text
C0678766 (UMLS CUI [1,1])
C0869039 (UMLS CUI [1,2])
Item
Drug Units
integer
C0013227 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Drug Units
Code List
Drug Units
CL Item
Capsule (1)
CL Item
Gram (2)
CL Item
Litre (3)
CL Item
Microgram (MCG) (4)
CL Item
Microlitre (5)
CL Item
Milligram (6)
CL Item
Mililitre (7)
CL Item
Tablet (8)
CL Item
Unknown (9)
Item
Drug Frequency
integer
C3476109 (UMLS CUI [1])
Drug Frequency
Code List
Drug Frequency
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 week (4)
CL Item
5 times per day (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)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Medication Route
Code List
Medication Route
CL Item
Inhalation (1)
CL Item
Intramuscular (2)
CL Item
Intranasal (3)
CL Item
Injection (4)
CL Item
Intravenous (5)
CL Item
Nasal (6)
CL Item
Other (7)
CL Item
Oral (8)
CL Item
Subcutaneous (9)
Drug Start Date
Item
Drug Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Drug taken prior to study?
Item
Drug taken prior to study?
boolean
C0013227 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Is Medication ongoing?
Item
Is Medication ongoing?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medication End Date
Item
If Medication is not ongoing, speciffy End Date.
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Medication type
integer
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Medication type
Code List
Medication type
CL Item
Asthma Medication (8)
CL Item
COPD Medication (14)
Item Group
IP Device Malfunction
C1881681 (UMLS CUI-1)
Investigational product container number
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Mark all applicate reasons for device malfunction
integer
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Mark all applicate reasons for device malfunction
Code List
Mark all applicate reasons for device malfunction
CL Item
Mouthpiece cover does not stay at the fully actuated position (20)
CL Item
Mouthpiece cover came apart from the mechanism (21)
CL Item
Inhaler is cracked or broken apart (22)
CL Item
Difficult to open mouthpiece cover/force to actuate was too high (23)
CL Item
Dilticult to close mouthpiece cover (24)
CL Item
Powder fell out prior to use (25)
CL Item
No powder came  (26)
CL Item
Device squeaks in operation (27)
CL Item
Device rattles in operation (28)
CL Item
Dose counter did not count (29)
CL Item
Dose counter is ambiguous (30)
CL Item
Dose counter overcounted (31)
CL Item
Dose counter undercounted (32)
CL Item
Difficult to pull air through the device as described in the leaflet (33)
CL Item
Device smelt/bad odour when pack opened (34)
CL Item
Other, specify (35)
If other reasons for device malfunction, specify
Item
If other reasons for device malfunction, specify.
text
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Chest X-Ray
C0039985 (UMLS CUI-1)
Date of x-ray
Item
Date of x-ray
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Diagnosis of pneumonia
Item
Were findings consistent with a diagnosis of pneumonia?
boolean
C0221566 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
Item Group
Pharmacogenetic (PGx) Research Consent/ Sample Collection
C0031325 (UMLS CUI-1)
C0035168 (UMLS CUI-2)
C0200345 (UMLS CUI-4)
Item
Has informed consent been obtained for PGx research?
text
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Has informed consent been obtained for PGx research?
Code List
Has informed consent been obtained for PGx research?
CL Item
Yes, record Date informed consent obtained for PGx research and if sample has been collected. (Y)
CL Item
No , check reason (N)
Date informed consent was obtained
Item
If informed consent was obtained for PGx research, record date.
date
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C2985782 (UMLS CUI [2])
Has sample for PGx been collected?
Item
If informed consent was obtained for PGx research, has sample been collected?
boolean
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C2985782 (UMLS CUI [2])
C0200345 (UMLS CUI [3])
Date sample taken for PGx research
Item
If sample has been collected for PGx research, record date sample taken.
date
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C1302413 (UMLS CUI [2])
Item
If informed consent was not obtained for PGx research, check reason
integer
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C1882120 (UMLS CUI [1,4])
C0392360 (UMLS CUI [2])
Reason for informed consent not obtained
Code List
If informed consent was not obtained for PGx research, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Other reason for informed consent not beeing obtained
Item
If other reason for informed consent not beeing obtained for PGx research, specify.
text
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Investigational product container number
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Visit Investigational Product Dispensed
integer
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Visit Investigational Product Dispensed
Code List
Visit Investigational Product Dispensed
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Unscheduled (7)
Date Investigational Product Dispensed
Item
Date Investigational Product Dispensed
date
C0947323 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Start Date Investigational Product
Item
Start Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Dose Counter Start
Item
Dose Counter Start
text
C0678766 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Item
Visit Investigational Product Returned
integer
C0304229 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Visit Investigational Product Returned
Code List
Visit Investigational Product Returned
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (7)
CL Item
Early withdrawal (8)
CL Item
Unscheduled  (9)
CL Item
Follow- up (10)
Date Investigational Product Returned
Item
Date Investigational Product Returned
date
C0013230 (UMLS CUI [1,1])
C2826249 (UMLS CUI [1,2])
End Date Investigational Product
Item
End Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Dose Counter Stop
Item
Dose Counter Stop
text
C0678766 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
Item Group
Unscheduled Asthma related Healthcare Resource Utilisation
C1704738 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0004096 (UMLS CUI-3)
Date of contact
Item
Date of contact
date
C0805839 (UMLS CUI [1])
Number of home visits
Item
Number of home visits (day)
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Number of home visits (night)
Item
Number of home visits (night)
integer
C0020043 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,3])
Number of physician office/ practice visits
Item
Number of physician office/ practice visits
integer
C0545082 (UMLS CUI [1,1])
C0031834 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of urgent care/ outpatient clinic visits
Item
Number of urgent care/ outpatient clinic visits
integer
C1551285 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0029921 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,4])
Number of emergency room visits
Item
Number of emergency room visits
integer
C2114437 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of inpatient hospitalisation days
Item
Number of inpatient hospitalisation days - ICU
integer
C0420496 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Number of inpatient hospitalisation days - General ward
Item
Number of inpatient hospitalisation days - General ward
integer
C0420496 (UMLS CUI [1,1])
C0043030 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
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