Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Blood pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Code List
Subject position
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
Oropharyngeal candidiasis
Item
Does the subject have clinical visual evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1])
Item
How do you rate the ease of use of the inhaler?
integer
C1272700 (UMLS CUI [1,1])
C0021461 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
Code List
How do you rate the ease of use of the inhaler?
CL Item
Very Difficult (5)
Item
How easily are you able to tell how many doses of medication are left in the inhaler?
integer
C1272700 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0021461 (UMLS CUI [2,3])
Code List
How easily are you able to tell how many doses of medication are left in the inhaler?
CL Item
Very difficult (5)
Did the subject use the device correctly?
Item
Did the subject use the device correctly?
boolean
C0699733 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
Item
If subject does not use the device correctly, what did subject do incorrectly? ´
integer
C3544346 (UMLS CUI [1])
Code List
If subject does not use the device correctly, what did subject do incorrectly? ´
CL Item
Open the device (1)
CL Item
Inhale the device (2)
CL Item
Close the device (3)
Item
If subject does not use the device correctly, record number of times subject required additional instruction.
integer
C3544346 (UMLS CUI [1])
C1442085 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
Code List
If subject does not use the device correctly, record number of times subject required additional instruction.
Did the subject withdraw at this visit?
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1])
C0545082 (UMLS CUI [2])
Date Sample(s) Taken
Item
Date Sample(s) Taken
date
C1302413 (UMLS CUI [1])
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Liver chemistry event for the lab samples collected at this visit
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
Item
Specify type of liver chemistry event.
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Specify type of liver chemistry event.
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria). Obtain tests as per protocol. (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria, has been monitored for the protocol specified time period and continues to meet liver chemistry monitoring criteria). Stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed in InForm. If InForm is unavailable, the SAE form should be faxed to GSK. (2)