ID

41271

Beschrijving

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Trefwoorden

Versies (1)
  1. 09-08-20 09-08-20 -
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GlaxoSmithKline

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9 augustus 2020

DOI

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Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

Engels

Randomisation Number; Treatment confirmation; Pharmacokinetics Blood; Pharmacokinetic Sampling Urine Interval Collection Data

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Randomisation Number (Treatment Period 1)
Beschrijving

Randomisation Number (Treatment Period 1)

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number
Beschrijving

Record randomisation number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Beschrijving

Investigational Product

Datatype

integer

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschrijving

Date of Dose

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beschrijving

Time of Dose

Datatype

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Dose
Beschrijving

Dose

Datatype

float

Alias
UMLS CUI [1]
C3174092
Medication Route
Beschrijving

Medication Route

Datatype

integer

Alias
UMLS CUI [1]
C0013153
Treatment Confirmation
Beschrijving

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e. g. treatment which the subject was assigned to) during this dosing interval?
Beschrijving

Did the subject receive the correct treatment (e. g. treatment which the subject was assigned to) during this dosing interval?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment, record reasons
Beschrijving

If the subject did not receive the correct treatment, record reasons

Datatype

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360
Pharmacokinetics - Blood (Treatment Period 1)
Beschrijving

Pharmacokinetics - Blood (Treatment Period 1)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample - check if taken
Beschrijving

Sample - check if taken

Datatype

integer

Alias
UMLS CUI [1]
C1277698
Sample number
Beschrijving

Sample number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Treatment Period 2)
Beschrijving

Pharmacokinetics - Blood (Treatment Period 2)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample - check if taken
Beschrijving

Sample - check if taken

Datatype

integer

Alias
UMLS CUI [1]
C1277698
Sample number
Beschrijving

Sample number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Treatment Period 3)
Beschrijving

Pharmacokinetics - Blood (Treatment Period 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample - check if taken
Beschrijving

Sample - check if taken

Datatype

integer

Alias
UMLS CUI [1]
C1277698
Sample number
Beschrijving

Sample number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Treatment Period 4)
Beschrijving

Pharmacokinetics - Blood (Treatment Period 4)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample - check if taken
Beschrijving

Sample - check if taken

Datatype

integer

Alias
UMLS CUI [1]
C1277698
Sample number
Beschrijving

Sample number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Treatment Period 5)
Beschrijving

Pharmacokinetics - Blood (Treatment Period 5)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample - check if taken
Beschrijving

Sample - check if taken

Datatype

integer

Alias
UMLS CUI [1]
C1277698
Sample number
Beschrijving

Sample number

Datatype

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)
Beschrijving

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Beschrijving

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0808070
UMLS CUI [2]
C0439564
Pharmacokinetic Sampling Urine - Start Date
Beschrijving

Pharmacokinetic Sampling Urine - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0808070
Pharmacokinetic Sampling Urine - Actual Start Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Start Time

Datatype

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
UMLS CUI [2,3]
C0870078
Pharmacokinetic Sampling Urine - Stop Date
Beschrijving

Pharmacokinetic Sampling Urine - Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0806020
Pharmacokinetic Sampling Urine - Actual Stop Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Stop Time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1522314
Pharmacokinetic Sampling Urine - Total Sample Volume
Beschrijving

Pharmacokinetic Sampling Urine - Total Sample Volume

Datatype

float

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1278293
mL
Was all of the sample collected for this interval?
Beschrijving

Was all of the sample collected for this interval?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
Pharmacokinetic Sampling Urine - Check if sample taken
Beschrijving

Pharmacokinetic Sampling Urine - Check if sample taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C1883727
Pharmacokinetic Sampling Urine - Sample Number
Beschrijving

Pharmacokinetic Sampling Urine - Sample Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1299222
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)
Beschrijving

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Beschrijving

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0808070
UMLS CUI [2]
C0439564
Pharmacokinetic Sampling Urine - Start Date
Beschrijving

Pharmacokinetic Sampling Urine - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0808070
Pharmacokinetic Sampling Urine - Actual Start Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Start Time

Datatype

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
UMLS CUI [2,3]
C0870078
Pharmacokinetic Sampling Urine - Stop Date
Beschrijving

Pharmacokinetic Sampling Urine - Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0806020
Pharmacokinetic Sampling Urine - Actual Stop Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Stop Time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1522314
Pharmacokinetic Sampling Urine - Total Sample Volume
Beschrijving

Pharmacokinetic Sampling Urine - Total Sample Volume

Datatype

float

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1278293
mL
Was all of the sample collected for this interval?
Beschrijving

Was all of the sample collected for this interval?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
Pharmacokinetic Sampling Urine - Check if sample taken
Beschrijving

Pharmacokinetic Sampling Urine - Check if sample taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C1883727
Pharmacokinetic Sampling Urine - Sample Number
Beschrijving

Pharmacokinetic Sampling Urine - Sample Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1299222
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)
Beschrijving

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Beschrijving

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0808070
UMLS CUI [2]
C0439564
Pharmacokinetic Sampling Urine - Start Date
Beschrijving

Pharmacokinetic Sampling Urine - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0808070
Pharmacokinetic Sampling Urine - Actual Start Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Start Time

Datatype

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
UMLS CUI [2,3]
C0870078
Pharmacokinetic Sampling Urine - Stop Date
Beschrijving

Pharmacokinetic Sampling Urine - Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0806020
Pharmacokinetic Sampling Urine - Actual Stop Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Stop Time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1522314
Pharmacokinetic Sampling Urine - Total Sample Volume
Beschrijving

Pharmacokinetic Sampling Urine - Total Sample Volume

Datatype

float

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1278293
mL
Was all of the sample collected for this interval?
Beschrijving

Was all of the sample collected for this interval?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
Pharmacokinetic Sampling Urine - Check if sample taken
Beschrijving

Pharmacokinetic Sampling Urine - Check if sample taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C1883727
Pharmacokinetic Sampling Urine - Sample Number
Beschrijving

Pharmacokinetic Sampling Urine - Sample Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1299222
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)
Beschrijving

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Beschrijving

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0808070
UMLS CUI [2]
C0439564
Pharmacokinetic Sampling Urine - Start Date
Beschrijving

Pharmacokinetic Sampling Urine - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0808070
Pharmacokinetic Sampling Urine - Actual Start Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Start Time

Datatype

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
UMLS CUI [2,3]
C0870078
Pharmacokinetic Sampling Urine - Stop Date
Beschrijving

Pharmacokinetic Sampling Urine - Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0806020
Pharmacokinetic Sampling Urine - Actual Stop Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Stop Time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1522314
Pharmacokinetic Sampling Urine - Total Sample Volume
Beschrijving

Pharmacokinetic Sampling Urine - Total Sample Volume

Datatype

float

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1278293
mL
Was all of the sample collected for this interval?
Beschrijving

Was all of the sample collected for this interval?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
Pharmacokinetic Sampling Urine - Check if sample taken
Beschrijving

Pharmacokinetic Sampling Urine - Check if sample taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C1883727
Pharmacokinetic Sampling Urine - Sample Number
Beschrijving

Pharmacokinetic Sampling Urine - Sample Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1299222
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)
Beschrijving

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Beschrijving

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0808070
UMLS CUI [2]
C0439564
Pharmacokinetic Sampling Urine - Start Date
Beschrijving

Pharmacokinetic Sampling Urine - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0808070
Pharmacokinetic Sampling Urine - Actual Start Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Start Time

Datatype

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
UMLS CUI [2,3]
C0870078
Pharmacokinetic Sampling Urine - Stop Date
Beschrijving

Pharmacokinetic Sampling Urine - Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C0806020
Pharmacokinetic Sampling Urine - Actual Stop Time
Beschrijving

Pharmacokinetic Sampling Urine - Actual Stop Time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1522314
Pharmacokinetic Sampling Urine - Total Sample Volume
Beschrijving

Pharmacokinetic Sampling Urine - Total Sample Volume

Datatype

float

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1278293
mL
Was all of the sample collected for this interval?
Beschrijving

Was all of the sample collected for this interval?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
Pharmacokinetic Sampling Urine - Check if sample taken
Beschrijving

Pharmacokinetic Sampling Urine - Check if sample taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2,1]
C0870078
UMLS CUI [2,2]
C1883727
Pharmacokinetic Sampling Urine - Sample Number
Beschrijving

Pharmacokinetic Sampling Urine - Sample Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1299222
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Similar models

Randomisation Number; Treatment confirmation; Pharmacokinetics Blood; Pharmacokinetic Sampling Urine Interval Collection Data

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Randomisation Number (Treatment Period 1)
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Record randomisation number
Item
Record randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Investigational Product
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])
Medication Route
Code List
Medication Route
CL Item
IH (1)
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
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 Group
Pharmacokinetics - Blood (Treatment Period 1)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
5 mins (2)
CL Item
15 mins (3)
CL Item
30 mins (4)
CL Item
1 hrs (5)
CL Item
2 hrs (6)
CL Item
4 hrs (7)
CL Item
6 hrs (8)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample - check if taken
integer
C1277698 (UMLS CUI [1])
Sample - check if taken
Code List
Sample - check if taken
CL Item
Sample taken (1)
Item
Sample number
integer
C1299222 (UMLS CUI [1])
Sample number
Code List
Sample number
CL Item
101 (1)
CL Item
102 (2)
CL Item
103 (3)
CL Item
104 (4)
CL Item
105 (5)
CL Item
106 (6)
CL Item
107 (7)
CL Item
108 (8)
Item Group
Pharmacokinetics - Blood (Treatment Period 2)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose  (1)
CL Item
5 mins  (2)
CL Item
15 mins  (3)
CL Item
30 mins  (4)
CL Item
1 hrs  (5)
CL Item
2 hrs  (6)
CL Item
4 hrs  (7)
CL Item
6 hrs (8)
CL Item
8 hrs (9)
CL Item
12 hrs (10)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample - check if taken
integer
C1277698 (UMLS CUI [1])
Sample - check if taken
Code List
Sample - check if taken
CL Item
Sample taken (1)
Item
Sample number
integer
C1299222 (UMLS CUI [1])
Sample number
Code List
Sample number
CL Item
201  (1)
CL Item
202  (2)
CL Item
203  (3)
CL Item
204  (4)
CL Item
205  (5)
CL Item
206  (6)
CL Item
207  (7)
CL Item
208  (8)
CL Item
209 (9)
CL Item
210 (10)
Item Group
Pharmacokinetics - Blood (Treatment Period 3)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose  (1)
CL Item
5 mins  (2)
CL Item
15 mins  (3)
CL Item
30 mins  (4)
CL Item
1 hrs  (5)
CL Item
2 hrs  (6)
CL Item
4 hrs  (7)
CL Item
6 hrs  (8)
CL Item
8 hrs  (9)
CL Item
12 hrs (10)
CL Item
16 hrs (11)
CL Item
24 hrs (12)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample - check if taken
integer
C1277698 (UMLS CUI [1])
Sample - check if taken
Code List
Sample - check if taken
CL Item
Sample taken (1)
Item
Sample number
integer
C1299222 (UMLS CUI [1])
Sample number
Code List
Sample number
CL Item
301  (1)
CL Item
302  (2)
CL Item
303  (3)
CL Item
304  (4)
CL Item
305  (5)
CL Item
306  (6)
CL Item
307  (7)
CL Item
308  (8)
CL Item
309  (9)
CL Item
310  (10)
CL Item
322 (11)
CL Item
312 (12)
Item Group
Pharmacokinetics - Blood (Treatment Period 4)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose  (1)
CL Item
5 mins  (2)
CL Item
15 mins  (3)
CL Item
30 mins  (4)
CL Item
1 hrs  (5)
CL Item
2 hrs  (6)
CL Item
4 hrs  (7)
CL Item
6 hrs  (8)
CL Item
8 hrs  (9)
CL Item
12 hrs (10)
CL Item
16 hrs (11)
CL Item
24 hrs (12)
CL Item
48 - 60 hrs (13)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample - check if taken
integer
C1277698 (UMLS CUI [1])
Sample - check if taken
Code List
Sample - check if taken
CL Item
Sample taken (1)
Item
Sample number
integer
C1299222 (UMLS CUI [1])
Sample number
Code List
Sample number
CL Item
401  (1)
CL Item
402  (2)
CL Item
403  (3)
CL Item
404  (4)
CL Item
405  (5)
CL Item
406  (6)
CL Item
407  (7)
CL Item
408  (8)
CL Item
409  (9)
CL Item
410  (10)
CL Item
411 (11)
CL Item
412 (12)
CL Item
413 (13)
Item Group
Pharmacokinetics - Blood (Treatment Period 5)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose  (1)
CL Item
5 mins  (2)
CL Item
15 mins  (3)
CL Item
30 mins  (4)
CL Item
1 hrs  (5)
CL Item
2 hrs  (6)
CL Item
4 hrs  (7)
CL Item
6 hrs  (8)
CL Item
8 hrs  (9)
CL Item
12 hrs (10)
CL Item
16 hrs (11)
CL Item
24 hrs (12)
CL Item
48 - 60 hrs (13)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample - check if taken
integer
C1277698 (UMLS CUI [1])
Sample - check if taken
Code List
Sample - check if taken
CL Item
Sample taken (1)
Item
Sample number
integer
C1299222 (UMLS CUI [1])
Sample number
Code List
Sample number
CL Item
501  (1)
CL Item
502  (2)
CL Item
503  (3)
CL Item
504  (4)
CL Item
505  (5)
CL Item
506  (6)
CL Item
507  (7)
CL Item
508  (8)
CL Item
509  (9)
CL Item
510 (10)
CL Item
511 (11)
CL Item
512 (12)
CL Item
513 (13)
Item Group
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
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])
Planned Relative Time Interval
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
CL Item
0hr - 2 hrs (1)
CL Item
2hrs - 8 hrs (2)
CL Item
8hrs - 24hrs (3)
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])
Pharmacokinetic Sampling Urine - Check if sample taken
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
CL Item
Sample taken (1)
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Sample Number
Code List
Pharmacokinetic Sampling Urine - Sample Number
CL Item
101 (1)
CL Item
102 (2)
CL Item
103 (3)
Item Group
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
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])
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
CL Item
0hr - 2 hrs  (1)
CL Item
2hrs - 8 hrs  (2)
CL Item
8hrs - 24hrs (3)
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])
Pharmacokinetic Sampling Urine - Check if sample taken
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
CL Item
Sample taken (1)
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Sample Number
Code List
Pharmacokinetic Sampling Urine - Sample Number
CL Item
201  (1)
CL Item
202  (2)
CL Item
203 (3)
Item Group
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
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])
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
CL Item
0hr - 2 hrs  (1)
CL Item
2hrs - 8 hrs  (2)
CL Item
8hrs - 24hrs (3)
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])
Pharmacokinetic Sampling Urine - Check if sample taken
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
CL Item
Sample taken (1)
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Sample Number
Code List
Pharmacokinetic Sampling Urine - Sample Number
CL Item
301  (1)
CL Item
302  (2)
CL Item
303 (3)
Item Group
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
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])
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
CL Item
0hr - 2 hrs  (1)
CL Item
2hrs - 8 hrs  (2)
CL Item
8hrs - 24hrs (3)
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])
Pharmacokinetic Sampling Urine - Check if sample taken
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
CL Item
Sample taken (1)
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Sample Number
Code List
Pharmacokinetic Sampling Urine - Sample Number
CL Item
401  (1)
CL Item
402  (2)
CL Item
403 (3)
Item Group
Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
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])
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
Code List
Pharmacokinetic Sampling Urine - Planned Relative Time Interval
CL Item
0hr - 2 hrs  (1)
CL Item
2hrs - 8 hrs  (2)
CL Item
8hrs - 24hrs (3)
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])
Pharmacokinetic Sampling Urine - Check if sample taken
Code List
Pharmacokinetic Sampling Urine - Check if sample taken
CL Item
Sample taken (1)
Item
Pharmacokinetic Sampling Urine - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
Pharmacokinetic Sampling Urine - Sample Number
Code List
Pharmacokinetic Sampling Urine - Sample Number
CL Item
501  (1)
CL Item
502  (2)
CL Item
503 (3)
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