ID

34976

Description

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.

Keywords

Versions (2)
  1. 2/4/19 2/4/19 -
  2. 2/6/19 2/6/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 6, 2019

DOI

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License

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

English

Local Laboratory -haematology, clinical chemistry, urinalysis

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Treatment period Day type
Description

Only applicable for treatment periods.

Data type

integer

Alias
UMLS CUI [1,1]
C2827038
UMLS CUI [1,2]
C0332307
Local Laboratory - haematology
Description

Local Laboratory - haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date of sample taken
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample taken
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Haematology test
Description

Haematology test

Data type

integer

Alias
UMLS CUI [1]
C0018941
Result of haematology test
Description

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).

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1274040
Local Laboratory - clinical chemistry
Description

Local Laboratory - clinical chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date of sample taken
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample taken
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Clinical Chemistry Test
Description

Note: FSH and LH are for females subjects only. FSH and LH are only for screening and unscheduled.

Data type

integer

Alias
UMLS CUI [1]
C0525044
Result of Clinical Chemistry Test
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0525044
Urine dipstick test
Description

Urine dipstick test

Alias
UMLS CUI-1
C0430370
Date of sample taken
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample taken
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Result of dipstick
Description

Result of dipstick

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Urinalysis - local
Description

Urinalysis - local

Alias
UMLS CUI-1
C0042014
Date of sample taken
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample taken
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Urinalysis Test
Description

Urinalysis Test

Data type

integer

Alias
UMLS CUI [1]
C0042014
Result of Urinalysis test
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
Was sedimentary microscopy performed?
Description

Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

Data type

text

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C2700128
Urinalysis (Microscopy) Test
Description

Urinalysis (Microscopy) Test

Data type

integer

Alias
UMLS CUI [1]
C0430397
Result of Urinalysis (Microscopy) Test
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0430397
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Similar models

Local Laboratory -haematology, clinical chemistry, urinalysis

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (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
TP1 (2)
CL Item
TP2 (3)
CL Item
TP3 (4)
CL Item
TP4 (5)
CL Item
Follow-up (6)
CL Item
Unscheduled (7)
Item
Treatment period Day type
integer
C2827038 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Treatment period Day type
Code List
Treatment period Day type
CL Item
Day-1 (1)
CL Item
24h (2)
Item Group
Local Laboratory - haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Time of sample taken
Item
Time of sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Haematology test
integer
C0018941 (UMLS CUI [1])
Haematology test
Code List
Haematology test
CL Item
Haemoglobin (1)
CL Item
RBC (2)
CL Item
MCV (3)
CL Item
MCH (4)
CL Item
MCHC (5)
CL Item
Haematocrit (6)
CL Item
Platelets (7)
CL Item
While Blood Cells (8)
CL Item
Neutrophils (9)
CL Item
Lymphocytes (10)
CL Item
Monocytes (11)
CL Item
Eosinophils (12)
CL Item
Basophils (13)
Result of haematology test
Item
Result of haematology test
text
C0474523 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Local Laboratory - clinical chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Time of sample taken
Item
Time of sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test
Code List
Clinical Chemistry Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Phosphate (3)
CL Item
Calcium (4)
CL Item
Chloride (5)
CL Item
Bicarbonate (6)
CL Item
Aspartate Transferase (AST) (7)
CL Item
Alanine Transferase (ALT) (8)
CL Item
Gamma GT (9)
CL Item
Alkaline Phosphatase (10)
CL Item
Total Protein (11)
CL Item
Globulin (12)
CL Item
Albumin (13)
CL Item
Total Bilirubin (14)
CL Item
Creatinine (15)
CL Item
Urea (16)
CL Item
Uric Acid (17)
CL Item
FSH (18)
CL Item
LH (19)
CL Item
Glucose (20)
Result of Clinical Chemistry Test
Item
Result of Clinical Chemistry Test
text
C1274040 (UMLS CUI [1,1])
C0525044 (UMLS CUI [1,2])
Item Group
Urine dipstick test
C0430370 (UMLS CUI-1)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Time of sample taken
Item
Time of sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Result of dipstick
Code List
Result of dipstick
CL Item
Negative (NEG)
CL Item
Positive (POS)
CL Item
No result (NR)
Item Group
Urinalysis - local
C0042014 (UMLS CUI-1)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Time of sample taken
Item
Time of sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Urinalysis Test
integer
C0042014 (UMLS CUI [1])
Urinalysis Test
Code List
Urinalysis Test
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
Item
Result of Urinalysis test
text
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of Urinalysis test
Code List
Result of Urinalysis test
CL Item
none or negative (NEG)
CL Item
tracer (TRA)
CL Item
+ or 1+ (1+)
CL Item
++ or 2+ (2+)
CL Item
+++ or 3+ (3+)
CL Item
++++ or 4+ (4+)
CL Item
+++++ or 5+ (5+)
CL Item
No result (NR)
Item
Was sedimentary microscopy performed?
text
C1518965 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Performance of sedimentary microscopy
Code List
Was sedimentary microscopy performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Urinalysis (Microscopy) Test
integer
C0430397 (UMLS CUI [1])
Urinalysis (Microscopy) Test
Code List
Urinalysis (Microscopy) Test
CL Item
White Blood Cells (1)
CL Item
Red Blood Cells (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Result of Urinalysis (Microscopy) Test
Item
Result of Urinalysis (Microscopy) Test
text
C1274040 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
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