ID

29900

Description

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Concomitant Medications.

Keywords

Versions (1)
  1. 26/04/2018 26/04/2018 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

26 de abril de 2018

DOI

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License

Creative Commons BY-NC 3.0
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Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

English

Concomitant Medications

1 forms  
Rhinitis Concomitant Medication
Description

Rhinitis Concomitant Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0035455
Were any rhinitis concomitant medications taken by the subject during the study?
Description

If Yes, answer the following items for each medication using Trade Names where possible.

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0035455
Drug Name
Description

Trade name preferred

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2607914
Unit dose
Description

Unit dose

Data type

float

Alias
UMLS CUI [1,1]
C2826767
UMLS CUI [1,2]
C2607914
Units
Description

The following list of abbreviations are examples which can be used to aid the completion of this item. This is not an all inclusive list and is for guidance only, other abbreviations not listed may be used if necessary. ACTU = Actuation AMP = Amoule APP = Application BOT = Bottle CC = Cubic centimeter CAP = Capsule G = Gram GTT = Drops IU = International Units L = Litre L/MIN = Litres per minute LOZ = Lozenge MCG = Microgram MCG/KG/MIN = Microgram per kilogram per minute MCL = Microlitre MMOL = Millimole NEB = Nebule PUFF = Puff SPR = Spray TAB = Tablet TBLSP = Tablespoon TSP = Teaspoon % = Percent UNK = Unkown

Data type

text

Alias
UMLS CUI [1,1]
C2826646
UMLS CUI [1,2]
C2607914
Frequency
Description

The following list of abbreviations are examples which can be used to aid the completion of this item. The list is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. OD/QD = 1 X daily BID = 2 X daily TID = 3 X daily QID = 4 X daily CONT = Continuous CUM = Cumulative dose D = Daily INT = Intermittent NA = Not available NOCT = At night OTH = Other PRN = As required QH = Every hour (quaque hora) QOD = Every other day QN = Every night (quaque nocte) SD = Single dose STAT = Immediately TAP = Taper UNK = Unknown

Data type

text

Alias
UMLS CUI [1,1]
C2826654
UMLS CUI [1,2]
C2607914
Route
Description

The following list of abbreviations are examples which can be used to aid the completion of this item. It is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. IM = Intramuscular IH = Inhalation IN = Intranasal INJ = Injection IV = Intravenous NS = Nasal OTH = Other PO = Oral PR = Rectal SC = Subcutaneous TP = Topical UNK = Unknown

Data type

text

Alias
UMLS CUI [1,1]
C2826730
UMLS CUI [1,2]
C2607914
Start Date
Description

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Data type

date

Alias
UMLS CUI [1,1]
C2826734
UMLS CUI [1,2]
C2607914
Taken Prior to Study?
Description

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Data type

text

Alias
UMLS CUI [1,1]
C2826667
UMLS CUI [1,2]
C2607914
Stop Date
Description

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Data type

date

Alias
UMLS CUI [1,1]
C2826744
UMLS CUI [1,2]
C2607914
Ongoing Medication
Description

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Data type

text

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C2607914
Non-Rhinitis Concomitant Medications
Description

Non-Rhinitis Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0205394
Were any non-rhinitis concomitant medications taken by the subject during the study?
Description

If Yes, record each medication in the following items of this itemgroup, use Trade Names where possible.

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0205394
Drug Name
Description

Trade names are preferred

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Unit Dose
Description

Unit Dose

Data type

float

Alias
UMLS CUI [1]
C2826767
Units
Description

The following list of abbreviations are examples which can be used to aid the completion of this item. This is not an all inclusive list and is for guidance only, other abbreviations not listed may be used if necessary. ACTU = Actuation AMP = Amoule APP = Application BOT = Bottle CC = Cubic centimeter CAP = Capsule G = Gram GTT = Drops IU = International Units L = Litre L/MIN = Litres per minute LOZ = Lozenge MCG = Microgram MCG/KG/MIN = Microgram per kilogram per minute MCL = Microlitre MMOL = Millimole NEB = Nebule PUFF = Puff SPR = Spray TAB = Tablet TBLSP = Tablespoon TSP = Teaspoon % = Percent UNK = Unkown

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency
Description

The following list of abbreviations are examples which can be used to aid the completion of this item. The list is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. OD/QD = 1 X daily BID = 2 X daily TID = 3 X daily QID = 4 X daily CONT = Continuous CUM = Cumulative dose D = Daily INT = Intermittent NA = Not available NOCT = At night OTH = Other PRN = As required QH = Every hour (quaque hora) QOD = Every other day QN = Every night (quaque nocte) SD = Single dose STAT = Immediately TAP = Taper UNK = Unknown

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

The following list of abbreviations are examples which can be used to aid the completion of this item. It is not all inclusive and is for guidance only, other abbreviations not listed may be used if necessary. IM = Intramuscular IH = Inhalation IN = Intranasal INJ = Injection IV = Intravenous NS = Nasal OTH = Other PO = Oral PR = Rectal SC = Subcutaneous TP = Topical UNK = Unknown

Data type

text

Alias
UMLS CUI [1]
C2826730
Reason for Medication
Description

Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: Current Medical Conditions (Medical and Allergy History), Non-Serious Adverse Events or Serious Adverse Events Form.

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date
Description

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Data type

date

Alias
UMLS CUI [1]
C2826734
Taken Prior to Study?
Description

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Data type

text

Alias
UMLS CUI [1]
C2826667
Stop Date
Description

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Data type

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Description

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Data type

text

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Rhinitis Concomitant Medication
C2347852 (UMLS CUI-1)
C0035455 (UMLS CUI-2)
Item
Were any rhinitis concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0035455 (UMLS CUI [1,2])
rhinitis concomitant medications
Code List
Were any rhinitis concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2607914 (UMLS CUI [1,3])
Unit dose
Item
Unit dose
float
C2826767 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
Units
Item
Units
text
C2826646 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
Route
Item
Route
text
C2826730 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
rhinitis concomitant medications
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Stop Date
Item
Stop Date
date
C2826744 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1,1])
C2607914 (UMLS CUI [1,2])
rhinitis concomitant medications
Code List
Ongoing Medication
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Non-Rhinitis Concomitant Medications
C2347852 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Were any non-rhinitis concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
rhinitis concomitant medications
Code List
Were any non-rhinitis concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
float
C2826767 (UMLS CUI [1])
Units
Item
Units
text
C2826646 (UMLS CUI [1])
Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C2826730 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
rhinitis concomitant medications
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Stop Date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
rhinitis concomitant medications
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
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