ID

34845

Beschrijving

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the physical examination and the medical condition form. It has to be filled in for screening.

Trefwoorden

  1. 30-01-19 30-01-19 -
  2. 31-01-19 31-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

31 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Physical examination, medical condition

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Physical Examination
Beschrijving

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Beschrijving

Physical Examination, Systems

Datatype

integer

Alias
UMLS CUI [1]
C0031809
Examination status
Beschrijving

"Not done" only applicable for: Breasts, Urogenital, Pelvic and Rectal.

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
If abnormal examination, please specify
Beschrijving

Abnormal examination

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0459424
Medical condition
Beschrijving

Medical condition

Alias
UMLS CUI-1
C0012634
Diagnosis
Beschrijving

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Datatype

text

Alias
UMLS CUI [1]
C0011900
Medical condition status
Beschrijving

Medical condition status

Datatype

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438

Similar models

Physical examination, medical condition

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Physical Examination
integer
C0031809 (UMLS CUI [1])
Code List
Physical Examination
CL Item
Hair and Skin  (1)
CL Item
Lymph nodes  (2)
CL Item
Eyes  (3)
CL Item
Ears, Nose and Throat  (4)
CL Item
Breasts  (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular  (7)
CL Item
Abdomen (8)
CL Item
Urogenital  (9)
CL Item
Pelvic  (10)
CL Item
Rectal  (11)
CL Item
Musculoskeletal (12)
CL Item
Neurological  (13)
CL Item
Mental Status (14)
Item
Examination status
text
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Examination status
CL Item
Normal (N)
CL Item
Abnormal (AN)
CL Item
Not Done (ND)
Abnormal examination
Item
If abnormal examination, please specify
text
C0031809 (UMLS CUI [1,1])
C0459424 (UMLS CUI [1,2])
Item Group
Medical condition
C0012634 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Medical condition status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Medical condition status
CL Item
Current (1)
CL Item
Past (2)

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