Record randomisation number
Item
Record randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Code List
Investigational Product
CL Item
68 (Diskus A) (1)
CL Item
69 (Diskus B) (2)
CL Item
172 (Handihaler) (3)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Code List
Medication Route
Did the subject receive the correct treatment (e. g. treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e. g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment, record reasons
Item
If the subject did not receive the correct treatment, record reasons
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0439564 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Pharmacokinetic Sampling Urine - Start Date
Item
Pharmacokinetic Sampling Urine - Start Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Start Time
Item
Pharmacokinetic Sampling Urine - Actual Start Time
time
C1301880 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
Pharmacokinetic Sampling Urine - Stop Date
Item
Pharmacokinetic Sampling Urine - Stop Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Stop Time
Item
Pharmacokinetic Sampling Urine - Actual Stop Time
time
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Total Sample Volume
Item
Pharmacokinetic Sampling Urine - Total Sample Volume
float
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])
Was all of the sample collected for this interval?
Item
Was all of the sample collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Pharmacokinetic Sampling Urine - Check if sample taken
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2,1])
C1883727 (UMLS CUI [2,2])
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Sample Number
Item
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0439564 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Pharmacokinetic Sampling Urine - Start Date
Item
Pharmacokinetic Sampling Urine - Start Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Start Time
Item
Pharmacokinetic Sampling Urine - Actual Start Time
time
C1301880 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
Pharmacokinetic Sampling Urine - Stop Date
Item
Pharmacokinetic Sampling Urine - Stop Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Stop Time
Item
Pharmacokinetic Sampling Urine - Actual Stop Time
time
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Total Sample Volume
Item
Pharmacokinetic Sampling Urine - Total Sample Volume
float
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])
Was all of the sample collected for this interval?
Item
Was all of the sample collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Pharmacokinetic Sampling Urine - Check if sample taken
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2,1])
C1883727 (UMLS CUI [2,2])
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Sample Number
Item
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0439564 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Pharmacokinetic Sampling Urine - Start Date
Item
Pharmacokinetic Sampling Urine - Start Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Start Time
Item
Pharmacokinetic Sampling Urine - Actual Start Time
time
C1301880 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
Pharmacokinetic Sampling Urine - Stop Date
Item
Pharmacokinetic Sampling Urine - Stop Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Stop Time
Item
Pharmacokinetic Sampling Urine - Actual Stop Time
time
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Total Sample Volume
Item
Pharmacokinetic Sampling Urine - Total Sample Volume
float
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])
Was all of the sample collected for this interval?
Item
Was all of the sample collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Pharmacokinetic Sampling Urine - Check if sample taken
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2,1])
C1883727 (UMLS CUI [2,2])
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Sample Number
Item
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0439564 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Pharmacokinetic Sampling Urine - Start Date
Item
Pharmacokinetic Sampling Urine - Start Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Start Time
Item
Pharmacokinetic Sampling Urine - Actual Start Time
time
C1301880 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
Pharmacokinetic Sampling Urine - Stop Date
Item
Pharmacokinetic Sampling Urine - Stop Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Stop Time
Item
Pharmacokinetic Sampling Urine - Actual Stop Time
time
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Total Sample Volume
Item
Pharmacokinetic Sampling Urine - Total Sample Volume
float
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])
Was all of the sample collected for this interval?
Item
Was all of the sample collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Pharmacokinetic Sampling Urine - Check if sample taken
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2,1])
C1883727 (UMLS CUI [2,2])
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Sample Number
Item
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0439564 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
CL Item
24hrs - 48hrs (4)
Pharmacokinetic Sampling Urine - Start Date
Item
Pharmacokinetic Sampling Urine - Start Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Start Time
Item
Pharmacokinetic Sampling Urine - Actual Start Time
time
C1301880 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
Pharmacokinetic Sampling Urine - Stop Date
Item
Pharmacokinetic Sampling Urine - Stop Date
date
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Actual Stop Time
Item
Pharmacokinetic Sampling Urine - Actual Stop Time
time
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Total Sample Volume
Item
Pharmacokinetic Sampling Urine - Total Sample Volume
float
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])
Was all of the sample collected for this interval?
Item
Was all of the sample collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Pharmacokinetic Sampling Urine - Check if sample taken
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2,1])
C1883727 (UMLS CUI [2,2])
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Code List
Pharmacokinetic Sampling Urine - Sample Number