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32870
Beschreibung
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
Stichworte
Versionen (1)
- 17.11.18 17.11.18 -
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GlaxoSmithKline
Hochgeladen am
17. November 2018
DOI
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138
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
Ähnliche Modelle
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
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
C0592503 (UMLS CUI [2])
Unit dose
Item
Unit dose
text
C2826646 (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
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)
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)
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])
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])
C0013231 (UMLS CUI [1,2])
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])
C2603343 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
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])
C0806914 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
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])
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])
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])
C0449238 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
CL Item
Days (1)
CL Item
Months (2)
CL Item
Weeks (3)
CL Item
Years (4)
CL Item
Non- Asthma (1)
CL Item
Asthma (2)
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
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])
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])
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])
C0439793 (UMLS CUI [1,2])
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])
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])
C0085978 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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)
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])
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])
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])
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])
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])
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])
C0439228 (UMLS CUI [1,2])
Item Group
Exacerbation Medications
C0349790 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
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])
C0869039 (UMLS CUI [1,2])
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)
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)
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])
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])
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])
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])
C0806020 (UMLS CUI [1,2])
CL Item
Asthma Medication (8)
CL Item
COPD Medication (14)
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])
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])
C0392360 (UMLS CUI [1,2])
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])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of x-ray
Item
Date of x-ray
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
C0032285 (UMLS CUI [2])
Item Group
Pharmacogenetic (PGx) Research Consent/ Sample Collection
C0031325 (UMLS CUI-1)
C0035168 (UMLS CUI-2)
C0200345 (UMLS CUI-4)
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])
C0035168 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
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])
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])
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])
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])
C0035168 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C1882120 (UMLS CUI [1,4])
C0392360 (UMLS CUI [2])
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])
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)
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])
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])
C0947323 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
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])
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])
C0808070 (UMLS CUI [1,2])
Dose Counter Start
Item
Dose Counter Start
text
C0678766 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
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])
C0332156 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
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])
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])
C0806020 (UMLS CUI [1,2])
Dose Counter Stop
Item
Dose Counter Stop
text
C0678766 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
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)
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])
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])
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])
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])
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])
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])
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])
C0043030 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])