ID

13821

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

Mots-clés

Versions (1)
  1. 08/03/2016 08/03/2016 -
Téléchargé le

8 mars 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Visit 2 - Clinical Trial on the Efficacy and Safety BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Chronic Sinusitis

Anglais

Visit 2

1 Formulaires  
  1. StudyEvent: ODM
    1. Visit 2
Header module
Description

Header module

Visit Number
Description

Visit Number

Type de données

integer

Alias
UMLS CUI [1]
C1549755
Patient Name
Description

Patient Name

Type de données

integer

Alias
UMLS CUI [1]
C1299487
Center #
Description

Center #

Type de données

integer

Alias
UMLS CUI [1]
C0009469
Date
Description

Date

Type de données

integer

Alias
UMLS CUI [1]
C0011008
Examination
Description

Examination

Temperature
Description

Body Temperature

Type de données

integer

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Blood pressure
Description

Blood pressure

Type de données

integer

Alias
UMLS CUI [1]
C0005823
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • 1/sec
Alias
UMLS CUI [1]
C0018810
1/sec
Examination of nose
Description

Examination of nose

Type de données

integer

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

Change of sinusitis since last visit

Type de données

integer

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

Please state name and type administered

Type de données

boolean

Alias
UMLS CUI [1]
C0003232
Endoscopy
Description

Endoscopy

Type de données

integer

Alias
UMLS CUI [1]
C0014245
Endoscopy findings
Description

Please state if the following symptoms have been detected, please also indicate left and right.

Type de données

integer

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

Urine pregnancy test

Type de données

integer

Alias
UMLS CUI [1]
C0430056
Dairy
Description

Has the patient´s dairy been checked?

Type de données

boolean

Alias
UMLS CUI [1]
C0376660
Concomitant drug
Description

Concomitant drug

Concomitant drug
Description

Please insert here all drugs, that the patient is taking during this trial and those drugs with dosage adaptation.

Type de données

integer

Alias
UMLS CUI [1]
C2347852
PRN Medicine
Description

PRN Medicine

PRN medicine
Description

PRN medicine

Type de données

integer

Alias
UMLS CUI [1]
C3166225
Non-drug therapy
Description

Non-drug therapy

Type de données

integer

Adverse event
Description

Adverse event

Did an adverse event occur?
Description

Did an adverse event occur?

Type de données

boolean

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

Is this a serious adverse event

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
Adverse event form
Description

Adverse event form

Type de données

integer

Alias
UMLS CUI [1]
C0877248
Countermeasures, progress,assessment and outcome of AE
Description

Countermeasures, progress,assessment and outcome of AE

Type de données

integer

Alias
UMLS CUI [1]
C1705586
Did a serious adverse event occur during the treatment?
Description

(If yes, please uinform study director immediately)

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
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Similar models

Visit 2

1 Formulaires
  1. StudyEvent: ODM
    1. Visit 2
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Body 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)
Item
Change of sinusitis since last visit
integer
C0037199 (UMLS CUI [1])
Change of sinusitis since last visit
Code List
Change of sinusitis since last visit
CL Item
Yes (1)
CL Item
No (2)
CL Item
If yes, please specify (3)
Were Antibiotics administered?
Item
Were Antibiotics administered?
boolean
C0003232 (UMLS CUI [1])
Item
Endoscopy
integer
C0014245 (UMLS CUI [1])
Endoscopy
Code List
Endoscopy
CL Item
Done (1)
CL Item
Note done (2)
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)
Dairy
Item
Dairy
boolean
C0376660 (UMLS CUI [1])
Item Group
Concomitant drug
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 Group
PRN Medicine
Item
PRN medicine
integer
C3166225 (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
Non-drug therapy
Code List
Non-drug therapy
CL Item
Typ of treatment (1)
CL Item
Start (2)
CL Item
End (3)
CL Item
Indication (4)
Item Group
Adverse event
Did an adverse event occur?
Item
Did an adverse event occur?
boolean
C0877248 (UMLS CUI [1])
Is this a serious adverse event
Item
Is this a serious adverse event
boolean
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)
Countermeasures, progress,assessment and outcome of AE
Item
Countermeasures, progress,assessment and outcome of AE
integer
C1705586 (UMLS CUI [1])
serious adverse event
Item
Did a serious adverse event occur during the treatment?
boolean
C1519255 (UMLS CUI [1])
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