ID

34172

Beschreibung

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma 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 propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. The study session 1.1 includes forms for reapeat screening (unscheduled. This document contains the forms: Hematology Data, Clinical Chemistry Data and Urinalysis. It has to filled in for screening, sessions 2, 3, 4, 5, 6 and 7. It also has to be filled in for Session 1.1. It also contains the worksheet for Serology Screen. It has to be filled in for screening (session 1). Furthermore this document contains the form pregnancy test. It has to be filled in for treatment period 1-5.

Stichworte

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GlaxoSmithKline

Hochgeladen am

15. Januar 2019

DOI

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Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

Englisch

Hematology Data, Clinical Chemistry Data, Urinalysis, Serology Screen, pregnancy test

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Session Number
Beschreibung

Session Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Hematology Data
Beschreibung

Hematology Data

Alias
UMLS CUI-1
C0474523
Lab code
Beschreibung

(For GSK use only)

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date hematology sample taken
Beschreibung

Date hematology sample

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Were there any clinically significant hematology abnormalities?
Beschreibung

If YES, record primary reason for the clinically significant abnormality in "Primary reason for clinically significant abnormality".

Datentyp

text

Alias
UMLS CUI [1,1]
C0850715
UMLS CUI [1,2]
C2985739
Hematology
Beschreibung

Hematology

Datentyp

integer

Alias
UMLS CUI [1]
C0474523
Results of hematoloy finding
Beschreibung

Results of hematoloy finding

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0474523
Primary reason for clinically significant abnormality
Beschreibung

Primary reason for clinically significant abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
if other reason for abnormality, specify
Beschreibung

Other reason for abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C3840932
Clinical Chemistry Data
Beschreibung

Clinical Chemistry Data

Alias
UMLS CUI-1
C0008000
Lab code
Beschreibung

(For GSK use only)

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date clinical chemistry sample taken
Beschreibung

Date clinical chemistry sample

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0008000
Time of sample
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Were there any clinically significant clinical chemistry abnormalities?
Beschreibung

If YES, record primary reason for the clinically significant abnormality in "Primary reason for clinically significant abnormality".

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2985739
Clinical chemistry
Beschreibung

Clinical chemistry

Datentyp

integer

Alias
UMLS CUI [1]
C0008000
Results of Clinical chemistry
Beschreibung

Results of Clinical chemistry

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0008000
Primary reason for clinically significant abnormality
Beschreibung

Primary reason for clinically significant abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
if other reason for abnormality, specify
Beschreibung

Other reason for abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C3840932
Urinalysis
Beschreibung

Urinalysis

Alias
UMLS CUI-1
C0042014
Lab code
Beschreibung

(For GSK use only)

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date Urinalysis sample taken
Beschreibung

Date Urinalysis sample

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042014
Time of sample
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Were there any clinically significant urinalysis abnormalities?
Beschreibung

If YES, record primary reason for the clinically significant abnormality in "Primary reason for clinically significant abnormality".

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2985739
Urinalysis: Dip Stick
Beschreibung

Urinalysis: Dip Stick

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C1160927
Dip-sticks
Beschreibung

Dip-sticks

Datentyp

integer

Alias
UMLS CUI [1]
C1160927
Results of Dip-sticks
Beschreibung

Enter numeric code in result column

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C1160927
Primary reason for clinically significant abnormality
Beschreibung

Primary reason for clinically significant abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
if other reason for abnormality, specify
Beschreibung

Other reason for abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C3840932
Urinalysis: Sedimentary Microcopy
Beschreibung

Urinalysis: Sedimentary Microcopy

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C2700128
Sedimentary microscopy
Beschreibung

Sedimentary microscopy

Datentyp

integer

Alias
UMLS CUI [1]
C2700128
Results of Sedimentary microscopy
Beschreibung

Results of Sedimentary microscopy

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C2700128
Primary reason for clinically significant abnormality
Beschreibung

Primary reason for clinically significant abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
if other reason for abnormality, specify
Beschreibung

Other reason for abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C3840932
Serology Screen
Beschreibung

Serology Screen

Alias
UMLS CUI-1
C0036743
Date sample taken
Beschreibung

Date of sample

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Hepatitis B surface antigen
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0201487
HIV
Beschreibung

If positive, EXCLUDE subject from the study.

Datentyp

text

Alias
UMLS CUI [1]
C0019682
Pregnancy Test
Beschreibung

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Is a pregnancy test applicable?
Beschreibung

Pregnancy test applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1706839
If a pregnancy test is applicable, was pregnancy test performed?
Beschreibung

Performance of pregnancy test

Datentyp

text

If pregnancy test is performed, tick one result.
Beschreibung

If positive, complete PREGNANCY NOTIFICATION FORM.

Datentyp

text

Alias
UMLS CUI [1]
C0427777
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Ähnliche Modelle

Hematology Data, Clinical Chemistry Data, Urinalysis, Serology Screen, pregnancy test

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Session Number
text
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
Session 1 (1)
CL Item
Session 2 (2)
CL Item
Session 3 (3)
CL Item
Session 4 (4)
CL Item
Session 5 (5)
CL Item
Session 6 (6)
CL Item
Session 7 (7)
CL Item
Session 1.1 (1.1)
Item Group
Hematology Data
C0474523 (UMLS CUI-1)
Lab code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date hematology sample
Item
Date hematology sample taken
date
C1302413 (UMLS CUI [1])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Were there any clinically significant hematology abnormalities?
text
C0850715 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Clinically significant hematology abnormalities
Code List
Were there any clinically significant hematology abnormalities?
CL Item
Yes (Y)
CL Item
No (N)
Item
Hematology
integer
C0474523 (UMLS CUI [1])
Hematology
Code List
Hematology
CL Item
Hemoglobin (1)
CL Item
Hematocrit (2)
CL Item
RBC (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
Platelets (7)
CL Item
Total WBC (8)
CL Item
Neutrophils (9)
CL Item
Lymphocytes (10)
CL Item
Monocytes (11)
CL Item
Eosinophils (12)
CL Item
Basophils (13)
CL Item
Reticulocytes (14)
Results of hematoloy finding
Item
Results of hematoloy finding
text
C1274040 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Item
Primary reason for clinically significant abnormality
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Primary reason for clinically significant abnormality
Code List
Primary reason for clinically significant abnormality
CL Item
Due to disease under study (D)
CL Item
Due to other concurrent disease (C)
CL Item
Reasonable possibility due to investigational product (T)
CL Item
Reasonable possibility due to other concomitant medication (M)
CL Item
Other, specify text in the box (X)
Other reason for abnormality
Item
if other reason for abnormality, specify
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Item Group
Clinical Chemistry Data
C0008000 (UMLS CUI-1)
Lab code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date clinical chemistry sample
Item
Date clinical chemistry sample taken
date
C1302413 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Were there any clinically significant clinical chemistry abnormalities?
text
C0008000 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Clinically significant hematology abnormalities
Code List
Were there any clinically significant clinical chemistry abnormalities?
CL Item
Yes (Y)
CL Item
No (N)
Item
Clinical chemistry
integer
C0008000 (UMLS CUI [1])
Clinical chemistry
Code List
Clinical chemistry
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Glucose (3)
CL Item
Total Protein (4)
CL Item
Albumin (5)
CL Item
Cholesterol (6)
CL Item
Triglycerides (7)
CL Item
Uric Acid (8)
CL Item
Creatinine (9)
CL Item
Urea (10)
CL Item
Total bilirubin (11)
CL Item
Alkaline Phosphatase (12)
CL Item
AST (SGOT) (13)
CL Item
ALT (SGPT) (14)
CL Item
GGT (15)
CL Item
Creatine kinase (16)
Results of Clinical chemistry
Item
Results of Clinical chemistry
text
C1274040 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item
Primary reason for clinically significant abnormality
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Primary reason for clinically significant abnormality
Code List
Primary reason for clinically significant abnormality
CL Item
Due to disease under study (D)
CL Item
Due to other concurrent disease (C)
CL Item
Reasonable possibility due to investigational product (T)
CL Item
Reasonable possibility due to other concomitant medication (M)
CL Item
Other, specify text in the box (X)
Other reason for abnormality
Item
if other reason for abnormality, specify
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Lab code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date Urinalysis sample
Item
Date Urinalysis sample taken
date
C1302413 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Were there any clinically significant urinalysis abnormalities?
text
C0042014 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Clinically significant hematology abnormalities
Code List
Were there any clinically significant urinalysis abnormalities?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Urinalysis: Dip Stick
C0042014 (UMLS CUI-1)
C1160927 (UMLS CUI-2)
Item
Dip-sticks
integer
C1160927 (UMLS CUI [1])
Dip-sticks
Code List
Dip-sticks
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
CL Item
Leucocytes (6)
Item
Results of Dip-sticks
text
C1274040 (UMLS CUI [1,1])
C1160927 (UMLS CUI [1,2])
Results of Dip-sticks
Code List
Results of Dip-sticks
CL Item
none or negative (0)
CL Item
trace (0.5)
CL Item
+ or 1+ (1)
CL Item
++ or 2+ (2)
CL Item
+++ or 3+ (3)
CL Item
++++ or 4+ (4)
Item
Primary reason for clinically significant abnormality
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Primary reason for clinically significant abnormality
Code List
Primary reason for clinically significant abnormality
CL Item
Due to disease under study (D)
CL Item
Due to other concurrent disease (C)
CL Item
Reasonable possibility due to investigational product (T)
CL Item
Reasonable possibility due to other concomitant medication (M)
CL Item
Other, specify text in the box (X)
Other reason for abnormality
Item
if other reason for abnormality, specify
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Item Group
Urinalysis: Sedimentary Microcopy
C0042014 (UMLS CUI-1)
C2700128 (UMLS CUI-2)
Item
Sedimentary microscopy
integer
C2700128 (UMLS CUI [1])
Sedimentary microscopy
Code List
Sedimentary microscopy
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Results of Sedimentary microscopy
Item
Results of Sedimentary microscopy
text
C1274040 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item
Primary reason for clinically significant abnormality
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Primary reason for clinically significant abnormality
Code List
Primary reason for clinically significant abnormality
CL Item
Due to disease under study (D)
CL Item
Due to other concurrent disease (C)
CL Item
Reasonable possibility due to investigational product (T)
CL Item
Reasonable possibility due to other concomitant medication (M)
CL Item
Other, specify text in the box (X)
Other reason for abnormality
Item
if other reason for abnormality, specify
text
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Item Group
Serology Screen
C0036743 (UMLS CUI-1)
Date of sample
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Hepatitis B surface antigen
text
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Positive (P)
CL Item
Negative (N)
Item
Hepatitis C antibody
text
C0201487 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis C antibody
CL Item
Positive (P)
CL Item
Negative (N)
Item
HIV
text
C0019682 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
HIV
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Is a pregnancy test applicable?
text
C0032976 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Pregnancy test applicable
Code List
Is a pregnancy test applicable?
CL Item
Yes (Y)
CL Item
No (N)
Item
If a pregnancy test is applicable, was pregnancy test performed?
text
Performance of pregnancy test
Code List
If a pregnancy test is applicable, was pregnancy test performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If pregnancy test is performed, tick one result.
text
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
If pregnancy test is performed, tick one result.
CL Item
Positive (P)
CL Item
Negative (N)
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