ID

26096

Description

Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

Keywords

  1. 10/9/17 10/9/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY-NC 3.0

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GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Main CRF

Main CRF

  1. StudyEvent: ODM
    1. Main CRF
lnvestigational Product Run-in
Description

lnvestigational Product Run-in

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3274438
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Investigator number
Description

Investigator Identifier

Data type

integer

Alias
UMLS CUI [1]
C2826689
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
Morning Dose Day number
Description

Morning Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332170
Evening Dose Day number
Description

Evening Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0587117
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
Description

Compliance behavior

Data type

text

Alias
UMLS CUI [1]
C1321605
Date of dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Time of dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Number of Inhalations Accuhaler
Description

Number of Inhalations Accuhaler

Data type

integer

Alias
UMLS CUI [1,1]
C0001559
UMLS CUI [1,2]
C1705566
Number of Inhalations BADPI
Description

Number of Inhalations BADPI

Data type

integer

Alias
UMLS CUI [1,1]
C0001559
UMLS CUI [1,2]
C1705566
Were there any significant changes to investigational product?
Description

NOTE: A significant change to investigational product includes those situations where a subject does not have the correct number of inhalations from the inhaler as detailed in the protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C3845681
UMLS CUI [1,2]
C0304229
If YES, specify investigational product changes, dates, and reasons
Description

Specify Changes

Data type

text

Alias
UMLS CUI [1,1]
C0443172
UMLS CUI [1,2]
C1521902
lnvestigational Product Treatment Period 1
Description

lnvestigational Product Treatment Period 1

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3538994
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Morning Dose Day number
Description

Morning Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332170
Evening Dose Day number
Description

Evening Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0587117
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
Description

Compliance behavior

Data type

text

Alias
UMLS CUI [1]
C1321605
Date of dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Time of dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Number of Inhalations Accuhaler
Description

Number of Inhalations Accuhaler

Data type

integer

Alias
UMLS CUI [1,1]
C0001559
UMLS CUI [1,2]
C1705566
Number of Inhalations BADPI
Description

Number of Inhalations BADPI

Data type

integer

Alias
UMLS CUI [1,1]
C0001559
UMLS CUI [1,2]
C1705566
Were there any significant changes to investigational product?
Description

NOTE: A significant change to investigational product includes those situations where a subject does not have the correct number of inhalations from the inhaler as detailed in the protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C3845681
UMLS CUI [1,2]
C0304229
If YES, specify investigational product changes, dates, and reasons
Description

Specify Changes

Data type

text

Alias
UMLS CUI [1,1]
C0443172
UMLS CUI [1,2]
C1521902
lnvestigational Product Treatment Period 2
Description

lnvestigational Product Treatment Period 2

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3538994
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Morning Dose Day number
Description

Morning Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332170
Evening Dose Day number
Description

Evening Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0587117
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
Description

Compliance behavior

Data type

text

Alias
UMLS CUI [1]
C1321605
Date of dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Time of dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Number of Inhalations Accuhaler
Description

Number of Inhalations Accuhaler

Data type

integer

Alias
UMLS CUI [1,1]
C0001559
UMLS CUI [1,2]
C1705566
Number of Inhalations BADPI
Description

Number of Inhalations BADPI

Data type

integer

Alias
UMLS CUI [1,1]
C0001559
UMLS CUI [1,2]
C1705566
Were there any significant changes to investigational product?
Description

NOTE: A significant change to investigational product includes those situations where a subject does not have the correct number of inhalations from the inhaler as detailed in the protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C3845681
UMLS CUI [1,2]
C0304229
If YES, specify investigational product changes, dates, and reasons
Description

Specify Changes

Data type

text

Alias
UMLS CUI [1,1]
C0443172
UMLS CUI [1,2]
C1521902
Pharmacogenetic Research
Description

Pharmacogenetic Research

Alias
UMLS CUI-1
C0031325
Has informed consent been obtained for Pharmacogenetic Research?
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for Pharmacogenetic Research
Description

Date informed consent obtained

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
If NO, specify reason below
Description

Informed consent refused

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
Has a blood sample been collected for Pharmacogenetic Research?
Description

Blood Sample Collection

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Has this subject withdrawn consent for Pharmacogenetic Research?
Description

Withdrawal of Consent

Data type

boolean

Alias
UMLS CUI [1]
C1707492
Has a request been made for sample destruction?
Description

Blood sample destruction

Data type

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes, check one reason
Description

Blood sample destruction reason

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the screening period?
Description

Concomitant medications during screening period

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1710477
Drug (Trade name preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2347852
Dose
Description

Medication Dose

Data type

float

Alias
UMLS CUI [1]
C3174092
Units
Description

Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Frequency
Description

e.g.: BID=2 x Daily OD=1 x Daily PRN=As required QID=4 x Daily TID=3 x Daily

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

e.g.: EXT=External ID=Intradermal IH=Inhalation IM=Intramuscular IR=Intraarticular IT=Intrathecal IV=Intravenous NA=Intranasal OTH=Other PE=Parenteral PO=Oral PR=Rectal SC=Subcutaneous SL=Sublingual TD=Transdermal TO=Topical UNK=Unknown VA=Vaginal

Data type

text

Alias
UMLS CUI [1]
C0013153
Date started
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Started Pre-Study
Description

Started Pre-Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0451613
start time
Description

Concomitant medication start time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
Concomitant Medication Stop Date
Description

Concomitant Medication Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Medication continued post-study
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Stop time
Description

Concomitant medication end time

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C2347852
Condition treated/Indication
Description

Condition treated/Indication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2347852
Was drug administered for an adverse event?
Description

If medication is given to treat an adverse event, then the ADVERSE EVENT must be recorded on the NON-SERIOUS ADVERSE EVENT or SERIOUS ADVERSE EVENT page(s) at the back of the CRF.

Data type

boolean

Alias
UMLS CUI [1]
C2981656
Was drug administered as a rescue medication?
Description

Rescue Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C0877248
Did the subject experience any non-serious adverse events during the study?
Description

If YES, indicate below

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Event
Description

Diagnosis only (if known) or signs / symptoms (list one per line)

Data type

text

Alias
UMLS CUI [1]
C0877248
Date of onset
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0574845
Time of onset
Description

00:00-23 59

Data type

time

Alias
UMLS CUI [1]
C0449244
Maximum Intensity
Description

Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Date of resolution
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985918
Time of resolution
Description

Time of resolution

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1]
C2826658
hh:mm
Action taken with investigational product(s) as a result of the non-serious AE
Description

Action taken with investigational product

Data type

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did subject withdraw from study as a result of this non-serious AE?
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to Investigational Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0015127
Does the AE meet the definition of serious?
Description

Seriousness

Data type

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Investigator number
Description

Investigator Identifier

Data type

integer

Alias
UMLS CUI [1]
C2826689
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Did the subject experience any serious adverse events during the study?
Description

Serious Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Event Diagnose only (if known) otherwise Sign/Symptom
Description

Serious Adverse Events

Data type

text

Alias
UMLS CUI [1]
C1519255
Date of onset
Description

Serious Adverse Event Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C1519255
Time of onset
Description

SAE onset time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
Maximum Intensity
Description

Maximum Intensity

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Outcome
Description

Outcome SAE

Data type

text

Alias
UMLS CUI [1]
C1705586
Date of resolution or death
Description

Date of resolution or death

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Time of resolution or death
Description

Time of resolution or death

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C1519255
UMLS CUI [2]
C1301931
hh:mm
Did subject withdraw from study as a result of this SAE?
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Description

Relationship to Investigational Product(s)

Data type

boolean

Alias
UMLS CUI [1]
C3828190
Does the AE meet the definition of serious?
Description

Definition of Seriousness

Data type

boolean

Alias
UMLS CUI [1,1]
C1704788
UMLS CUI [1,2]
C1710056
Possible Causes of SAE Other Than lnvestigational Product(s)
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Seriousness
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1710056
If fatal was an autopsy done/to be performed?
Description

autopsy done

Data type

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0884358
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Description

Medical conditions relevant to SAE

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
Date of Onset
Description

Serious Adverse Event Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Condition Present at Time of the SAE?
Description

Current Condition while SAE

Data type

boolean

Alias
UMLS CUI [1,1]
C3827351
UMLS CUI [1,2]
C1519255
If NO, date of last occurrence
Description

Current Condition while SAE

Data type

date

Alias
UMLS CUI [1,1]
C3827351
UMLS CUI [1,2]
C0011008
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Description

Other relevant risk factors

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Run-in Start date
Description

Details of lnvestigational Product(s)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Run-in Stop Date
Description

Details of lnvestigational Product(s)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Treatment Period 1 Start date
Description

Details of lnvestigational Product(s)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Treatment Period 1 Stop Date
Description

Details of lnvestigational Product(s)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Treatment Period 2 Start date
Description

Details of lnvestigational Product(s)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
Treatment Period 2 Stop Date
Description

Details of lnvestigational Product(s)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1522508
RELEVANT Concomitant Medications
Description

Include any concomitant medications that may contribute to the occurrence of the SAE

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519255
Drug name (Trade name preferred)
Description

Include any concomitant medications that may contribute to the occurrence of the SAE

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519255
Dose
Description

Medication Dose

Data type

integer

Alias
UMLS CUI [1]
C3174092
Unit
Description

e.g.: G=Gram L=Litre MCG=Microgram MCL=Microlitre MG=Milligram ML=Millilitre TAB=Tablet

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency (e.g. BID)
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Date Started
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Started Pre-Study
Description

Started Pre-Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0451613
Date Stopped
Description

Medication End Date

Data type

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Medication continued post-SAE
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Conditions treated/indication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Narrative/Comments
Description

Provide a textual description of the serious adverse event (including treatment of the event)

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Details of RELEVANT Assessments
Description

Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.

Data type

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1519255
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
Description

Reporting Investigator

Data type

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1533716
Name (print)
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Address
Description

Investigator Address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date of completion

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
Description

Additional or follow-up information

Data type

text

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C1519255
Name (print)
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Address
Description

Investigator Address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date of completion

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287

Similar models

Main CRF

  1. StudyEvent: ODM
    1. Main CRF
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
lnvestigational Product Run-in
C0304229 (UMLS CUI-1)
C3274438 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item
Morning Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
Code List
Morning Dose Day number
CL Item
Day-1 (1)
CL Item
Day-2 (2)
CL Item
Day-3 (3)
CL Item
Day-4 (4)
CL Item
Day-5 (5)
CL Item
Day-6 (6)
CL Item
Day-7 (7)
CL Item
Day-8 (8)
CL Item
Day-9 (9)
CL Item
Day-10 (10)
CL Item
Day-11 (11)
CL Item
Day-12 (12)
CL Item
Day-13 (13)
CL Item
Day-14 (14)
CL Item
Day-15 (15)
CL Item
Day-16 (16)
Item
Evening Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
Code List
Evening Dose Day number
CL Item
Day-1 (1)
CL Item
Day-2 (2)
CL Item
Day-3 (3)
CL Item
Day-4 (4)
CL Item
Day-5 (5)
CL Item
Day-6 (6)
CL Item
Day-7 (7)
CL Item
Day-8 (8)
CL Item
Day-9 (9)
CL Item
Day-10 (10)
CL Item
Day-11 (11)
CL Item
Day-12 (12)
CL Item
Day-13 (13)
CL Item
Day-14 (14)
CL Item
Day-15 (15)
CL Item
Day-16 (16)
Compliance behavior
Item
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
text
C1321605 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Number of Inhalations Accuhaler
Item
Number of Inhalations Accuhaler
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
Number of Inhalations BADPI
Item
Number of Inhalations BADPI
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
significant changes to investigational product?
Item
Were there any significant changes to investigational product?
boolean
C3845681 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Specify Changes
Item
If YES, specify investigational product changes, dates, and reasons
text
C0443172 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
lnvestigational Product Treatment Period 1
C0304229 (UMLS CUI-1)
C3538994 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Morning Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
Code List
Morning Dose Day number
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Item
Evening Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
Code List
Evening Dose Day number
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Compliance behavior
Item
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
text
C1321605 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Number of Inhalations Accuhaler
Item
Number of Inhalations Accuhaler
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
Number of Inhalations BADPI
Item
Number of Inhalations BADPI
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
significant changes to investigational product?
Item
Were there any significant changes to investigational product?
boolean
C3845681 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Specify Changes
Item
If YES, specify investigational product changes, dates, and reasons
text
C0443172 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
lnvestigational Product Treatment Period 2
C0304229 (UMLS CUI-1)
C3538994 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Morning Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
Code List
Morning Dose Day number
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Item
Evening Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
Code List
Evening Dose Day number
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Compliance behavior
Item
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
text
C1321605 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Number of Inhalations Accuhaler
Item
Number of Inhalations Accuhaler
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
Number of Inhalations BADPI
Item
Number of Inhalations BADPI
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
significant changes to investigational product?
Item
Were there any significant changes to investigational product?
boolean
C3845681 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Specify Changes
Item
If YES, specify investigational product changes, dates, and reasons
text
C0443172 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Pharmacogenetic Research
C0031325 (UMLS CUI-1)
Informed Consent
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained
Item
Date informed consent obtained for Pharmacogenetic Research
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item
If NO, specify reason below
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Code List
If NO, specify reason below
CL Item
Subject declined (SD)
CL Item
Subject not asked by investigator (SI)
CL Item
Other (X)
Blood Sample Collection
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Withdrawal of Consent
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
boolean
C1707492 (UMLS CUI [1])
Blood sample destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If Yes, check one reason
CL Item
Subject requested (R)
CL Item
Screen failure (F)
CL Item
Other (X)
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant medications during screening period
Item
Were any concomitant medications taken by the subject during the screening period?
boolean
C2347852 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Units
CL Item
Gram (G)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Microlitre (MCL)
CL Item
Milligram (MG)
CL Item
Millilitre (ML)
CL Item
Tablet (TAB)
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Date started
date
C2826734 (UMLS CUI [1])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Concomitant medication start time
Item
start time
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Stop Date
Item
Concomitant Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication
Item
Medication continued post-study
boolean
C2826666 (UMLS CUI [1])
Concomitant medication end time
Item
Stop time
time
C1522314 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Condition treated/Indication
Item
Condition treated/Indication
text
C0392360 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Adverse event treatment
Item
Was drug administered for an adverse event?
boolean
C2981656 (UMLS CUI [1])
Rescue Medication
Item
Was drug administered as a rescue medication?
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Item Group
Non-Serious Adverse Events
C0877248 (UMLS CUI-1)
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Non-serious adverse events
Item
Event
text
C0877248 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Time of onset
Item
Time of onset
time
C0449244 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Outcome
text
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Resolved  (R)
CL Item
Resolved with sequelae  (S)
CL Item
Not resolved (N)
Date of resolution
Item
Date of resolution
date
C2985918 (UMLS CUI [1])
Time of resolution
Item
Time of resolution
time
C2826658 (UMLS CUI [1])
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (X)
Withdrawal
Item
Did subject withdraw from study as a result of this non-serious AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Serious Adverse Events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
White  (1)
CL Item
Black  (2)
CL Item
Asian  (3)
CL Item
Other (4)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Serious Adverse Events
Item
Event Diagnose only (if known) otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Onset Date
Item
Date of onset
date
C2985916 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE onset time
Item
Time of onset
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Outcome
text
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Resolved  (R)
CL Item
Resolved with Sequelae  (S)
CL Item
Fatal  (F)
CL Item
Not Resolved (N)
Date of resolution or death
Item
Date of resolution or death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time of resolution or death
Item
Time of resolution or death
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
Withdrawal
Item
Did subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C3828190 (UMLS CUI [1])
Definition of Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1704788 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item
Possible Causes of SAE Other Than lnvestigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Code List
Possible Causes of SAE Other Than lnvestigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (record in Section 8) (5)
CL Item
Activity related to study participation (e.g. , procedures) (6)
CL Item
Other, specify (7)
Item
Seriousness
text
C1710056 (UMLS CUI [1])
Code List
Seriousness
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other,please specify (F)
autopsy done
Item
If fatal was an autopsy done/to be performed?
boolean
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Medical conditions relevant to SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Onset Date
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Current Condition while SAE
Item
Condition Present at Time of the SAE?
boolean
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Current Condition while SAE
Item
If NO, date of last occurrence
date
C3827351 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Other relevant risk factors
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Run-in Start date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Run-in Stop Date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 1 Start date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 1 Stop Date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 2 Start date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 2 Stop Date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
RELEVANT Concomitant Medications
Item
RELEVANT Concomitant Medications
text
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Drug name
Item
Drug name (Trade name preferred)
text
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Medication Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency (e.g. BID)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medication Start Date
Item
Date Started
date
C2826734 (UMLS CUI [1])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Medication End Date
Item
Date Stopped
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Ongoing Medication
Item
Medication continued post-SAE
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Conditions treated/indication
text
C2826696 (UMLS CUI [1])
Comments
Item
Narrative/Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Assessments
Item
Details of RELEVANT Assessments
text
C0220825 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Reporting Investigator
Item
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
boolean
C0008961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Investigator Name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
Additional or follow-up information
Item
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
text
C1533716 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator Name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])

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