ID

13817

Description

This study evaluates the effectiveness and safety of MFNS in improving the Treatment of Chronic Sinusitis. ODM derived from:"Randomized Double-blind Clinical Trial on the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) or Placebo in the Treatment of Chronic Sinusitis". Leader of the clinical trial: Prof. Dr. med. Karl Hörmann Direktor der Hals-Nasen-Ohren-Klinik / Clinic Director Ear, Nose and Throat Clinic Medical Faculty Mannheim Heidelberg University at the University Medical Centre Mannheim Theodor-Kutzer-Ufer 1-3 68167 Mannheim

Keywords

Versions (1)
  1. 3/8/16 3/8/16 -
Uploaded on

March 8, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Visit 5 - Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis

English

Visit 5

1 forms  
  1. StudyEvent: ODM
    1. Visit 5
Header module
Description

Header module

Visit Number
Description

Visit Number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Patient Name
Description

Patient Name

Data type

integer

Alias
UMLS CUI [1]
C1299487
Center #
Description

Center #

Data type

integer

Alias
UMLS CUI [1]
C0009469
Date
Description

Date

Data type

integer

Alias
UMLS CUI [1]
C0011008
Examination
Description

Examination

Temperature
Description

Temperature

Data type

integer

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Blood pressure
Description

Blood pressure

Data type

integer

Alias
UMLS CUI [1]
C0005823
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • 1/sec
Alias
UMLS CUI [1]
C0018810
1/sec
Examination of nose
Description

Examination of nose

Data type

integer

Alias
UMLS CUI [1]
C0558826
Change of sinusitis since last visit
Description

Change of sinusitis since last visit

Data type

integer

Alias
UMLS CUI [1]
C0037199
Were Antibiotics administered?
Description

If yes, please specify type of Antibiotics

Data type

integer

Alias
UMLS CUI [1]
C0003232
Endoscopy
Description

Endoscopy

Data type

integer

Alias
UMLS CUI [1]
C0014245
Endoscopy findings
Description

Endoscopy findings

Data type

integer

Alias
UMLS CUI [1,1]
C0014245
UMLS CUI [1,2]
C0243095
Urine pregnancy test
Description

Urine pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0430056
Medication checked and weighed?
Description

Please state weight

Data type

integer

Dairy checked?
Description

Dairy checked?

Data type

boolean

Alias
UMLS CUI [1]
C0376660
Medication
Description

Medication

Concomitant drug
Description

Concomitant drug

Data type

integer

Alias
UMLS CUI [1]
C2347852
PRN medicine
Description

PRN medicine

Data type

integer

Alias
UMLS CUI [1]
C3176065
Non-drug therapy
Description

Non-drug therapy

Data type

integer

Alias
UMLS CUI [1]
C3661844
Adverse event
Description

Adverse event

Did an adverse event occur?
Description

Did an adverse event occur?

Data type

integer

Alias
UMLS CUI [1]
C0877248
Is this a serious adverse event ?
Description

Is this a serious adverse event ?

Data type

integer

Alias
UMLS CUI [1]
C1519255
Adverse event form
Description

Adverse event form

Data type

integer

Alias
UMLS CUI [1]
C0877248
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Similar models

Visit 5

1 forms
  1. StudyEvent: ODM
    1. Visit 5
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Patient Name
Item
Patient Name
integer
C1299487 (UMLS CUI [1])
Center #
Item
Center #
integer
C0009469 (UMLS CUI [1])
Date
Item
Date
integer
C0011008 (UMLS CUI [1])
Item Group
Examination
Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Item
Blood pressure
integer
C0005823 (UMLS CUI [1])
Blood pressure
Code List
Blood pressure
CL Item
Systolic (1)
C0871470 (UMLS CUI-1)
CL Item
Diastolic ( 2)
C0428883 (UMLS CUI-1)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item
Examination of nose
integer
C0558826 (UMLS CUI [1])
Examination of nose
Code List
Examination of nose
CL Item
Done (1)
CL Item
Note done (2)
CL Item
Finding (3)
C0243095 (UMLS CUI-1)
Change of sinusitis since last visit
Item
Change of sinusitis since last visit
integer
C0037199 (UMLS CUI [1])
Were Antibiotics administered?
Item
Were Antibiotics administered?
integer
C0003232 (UMLS CUI [1])
Item
Endoscopy
integer
C0014245 (UMLS CUI [1])
Endoscopy
Code List
Endoscopy
CL Item
Done, please state date (1)
C0802603 (UMLS CUI-1)
CL Item
Not done (2)
C1272696 (UMLS CUI-1)
CL Item
Findings (3)
C0243095 (UMLS CUI-1)
Item
Endoscopy findings
integer
C0014245 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Endoscopy findings
Code List
Endoscopy findings
CL Item
edema (1)
C0013604 (UMLS CUI-1)
CL Item
flow of secretion (2)
C0036536 (UMLS CUI-1)
CL Item
irritation  (3)
C1706307 (UMLS CUI-1)
CL Item
ulceration (4)
C0041582 (UMLS CUI-1)
Item
Urine pregnancy test
integer
C0430056 (UMLS CUI [1])
Urine pregnancy test
Code List
Urine pregnancy test
CL Item
Result (1)
C2826772 (UMLS CUI-1)
CL Item
Not done (2)
C1272696 (UMLS CUI-1)
Medication checked and weighed?
Item
Medication checked and weighed?
integer
Dairy checked?
Item
Dairy checked?
boolean
C0376660 (UMLS CUI [1])
Item Group
Medication
Item
Concomitant drug
integer
C2347852 (UMLS CUI [1])
Concomitant drug
Code List
Concomitant drug
CL Item
Drug name (1)
C0013227 (UMLS CUI-1)
CL Item
Dosage (2)
C0178602 (UMLS CUI-1)
CL Item
Start of medication (3)
C0451613 (UMLS CUI-1)
CL Item
End of medication (4)
C2826659 (UMLS CUI-1)
CL Item
Indication (5)
C3146298 (UMLS CUI-1)
Item
PRN medicine
integer
C3176065 (UMLS CUI [1])
PRN medicine
Code List
PRN medicine
CL Item
Drug (1)
C0013227 (UMLS CUI-1)
CL Item
Dosage (2)
C0178602 (UMLS CUI-1)
CL Item
Date (3)
C0011008 (UMLS CUI-1)
CL Item
Indication (4)
C3146298 (UMLS CUI-1)
Item
Non-drug therapy
integer
C3661844 (UMLS CUI [1])
Non-drug therapy
Code List
Non-drug therapy
CL Item
Typ of treatment (1)
CL Item
Start (2)
C0808070 (UMLS CUI-1)
CL Item
End (3)
C0806020 (UMLS CUI-1)
CL Item
Indication (4)
C3146298 (UMLS CUI-1)
Item Group
Adverse event
Did an adverse event occur?
Item
Did an adverse event occur?
integer
C0877248 (UMLS CUI [1])
Is this a serious adverse event ?
Item
Is this a serious adverse event ?
integer
C1519255 (UMLS CUI [1])
Item
Adverse event form
integer
C0877248 (UMLS CUI [1])
Adverse event form
Code List
Adverse event form
CL Item
Description of adverse event icd (1)
C1632372 (UMLS CUI-1)
CL Item
Date and time of adverse event (2)
C2826793 (UMLS CUI-1)
CL Item
Previously in CRF documted (3)
CL Item
Progress (4)
C1335499 (UMLS CUI-1)
CL Item
Related to study drug? (5)
C0013175 (UMLS CUI-1)
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