ID

41271

Descrição

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)

Palavras-chave

D016430

Lungenkrankheiten, chronisch obstruktive

Pulmonale Krankheiten (Fachgebiet)

Pharmakokinetik

09/08/2020 09/08/2020 -

Titular dos direitos

GlaxoSmithKline

Transferido a

9 de agosto de 2020

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

model
Detalhes

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

1 Formulários

StudyEvent: ODM
1. Randomisation Number; Treatment confirmation; Pharmacokinetics Blood; Pharmacokinetic Sampling Urine Interval Collection Data

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Administrative

Item Group

Administrative

C1320722 (UMLS CUI-1)

Subject Identifier

Item

Subject Identifier

text

C2348585 (UMLS CUI [1])

Randomisation Number (Treatment Period 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])

Investigational Product

Item Group

Investigational Product

C0304229 (UMLS CUI-1)

Investigational Product

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])

Medication Route

Item

Medication Route

integer

C0013153 (UMLS CUI [1])

Medication Route

Code List

Medication Route

CL Item

IH (1)

Treatment Confirmation

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])

Pharmacokinetics - Blood (Treatment Period 1)

Item Group

Pharmacokinetics - Blood (Treatment Period 1)

C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Planned Relative Time

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])

Sample - check if taken

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)

Sample number

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)

Pharmacokinetics - Blood (Treatment Period 2)

Item Group

Pharmacokinetics - Blood (Treatment Period 2)

C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Planned Relative Time

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])

Sample - check if taken

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)

Sample number

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)

Pharmacokinetics - Blood (Treatment Period 3)

Item Group

Pharmacokinetics - Blood (Treatment Period 3)

C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Planned Relative Time

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])

Sample - check if taken

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)

Sample number

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)

Pharmacokinetics - Blood (Treatment Period 4)

Item Group

Pharmacokinetics - Blood (Treatment Period 4)

C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Planned Relative Time

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])

Sample - check if taken

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)

Sample number

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)

Pharmacokinetics - Blood (Treatment Period 5)

Item Group

Pharmacokinetics - Blood (Treatment Period 5)

C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)

Planned Relative Time

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])

Sample - check if taken

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)

Sample number

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)

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)

Item Group

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 1)

C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

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])

Pharmacokinetic Sampling Urine - Check if sample taken

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)

Pharmacokinetic Sampling Urine - Sample Number

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)

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)

Item Group

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 2)

C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

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])

Pharmacokinetic Sampling Urine - Check if sample taken

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)

Pharmacokinetic Sampling Urine - Sample Number

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)

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)

Item Group

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 3)

C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

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])

Pharmacokinetic Sampling Urine - Check if sample taken

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)

Pharmacokinetic Sampling Urine - Sample Number

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)

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)

Item Group

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 4)

C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

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])

Pharmacokinetic Sampling Urine - Check if sample taken

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)

Pharmacokinetic Sampling Urine - Sample Number

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)

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)

Item Group

Pharmacokinetic Sampling Urine Interval Collection Data (Treatment Period 5)

C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)

Pharmacokinetic Sampling Urine - Planned Relative Time Interval

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])

Pharmacokinetic Sampling Urine - Check if sample taken

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)

Pharmacokinetic Sampling Urine - Sample Number

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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ID

Descrição

Palavras-chave

Versões (1)

Titular dos direitos

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

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

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