ID
34976
Beschreibung
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 Local Laboratory -haematology, clinical chemistry and urinalysis form. It has to be filled in for screening, for TP1-4 Day-1, TP1-4 24 h, and follow-up.
Stichworte
Versionen (2)
- 04.02.19 04.02.19 -
- 06.02.19 06.02.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
6. Februar 2019
DOI
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Lizenz
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
Local Laboratory -haematology, clinical chemistry, urinalysis
- StudyEvent: ODM
Beschreibung
Local Laboratory - haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
Haematology test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1274040
Beschreibung
Local Laboratory - clinical chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
Note: FSH and LH are for females subjects only. FSH and LH are only for screening and unscheduled.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0525044
Beschreibung
If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0525044
Beschreibung
Urine dipstick test
Alias
- UMLS CUI-1
- C0430370
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
Result of dipstick
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschreibung
Urinalysis - local
Alias
- UMLS CUI-1
- C0042014
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
Urinalysis Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042014
Beschreibung
If the laboratory results are not available to report or if a lab error occurred, enter "NR" (the abbreviation for ’No Result’). If the laboratory test(s) need to be repeated, record results in the unscheduled form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
Beschreibung
Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518965
- UMLS CUI [1,2]
- C2700128
Beschreibung
Urinalysis (Microscopy) Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430397
Beschreibung
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0430397
Ähnliche Modelle
Local Laboratory -haematology, clinical chemistry, urinalysis
- StudyEvent: ODM
C0332307 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0008000 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C0525044 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,2])