ID

39858

Description

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the vital signs form. It has to be filled in for screening, V2b, V3, V4, V5, follow-up and if required for logs/ repeats.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Keywords

Versions (2)
  1. 2/17/20 2/17/20 -
  2. 2/24/20 2/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 24, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

English

Vital signs

1 forms  
  1. StudyEvent: ODM
    1. Vital signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

Please note for which visit you will fill in this document.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Actual date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Actual time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Body Height
Description

Only to fill in for screening.

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

Only to fill in for screening.

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Only to fill in for screening.

Data type

float

Measurement units
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Systolic blood pressure
Description

For V2b, V3, V4 and V5 the measurement has to be filled in pre-dose.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

For V2b, V3, V4 and V5 the measurement has to be filled in pre-dose.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

For V2b, V3, V4 and V5 the measurement has to be filled in pre-dose.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Description

For V2b, V3, V4 and V5 the measurement has to be filled in pre-dose.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
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Similar models

Vital signs

1 forms
  1. StudyEvent: ODM
    1. Vital signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
V2b (2)
CL Item
V3 (3)
CL Item
V4 (4)
CL Item
V5 (5)
CL Item
Follow-up (6)
CL Item
Logs/ repeats (7)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Actual date
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
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