ID

13261

Beskrivning

Prospective,multicentric,double blind and placebo-controlled Phase III clinical trial to determine efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in patients with allergic rhinoconjunctivits caused by grass or rye pollen. EudraCT-Nr. 2008-000513-29 Study-code:CLU-2008-001 Sponsor: ROXALL Medizin GmbH Carl-Petersen-Straße 4 20535 Hamburg Phone:040-8972520 Fax:040-89725223 Project coordinator: Dr.Jenny Uhlig ROXALL Medizin GmbH Head of clinical investigation: Prof.Dr.med.Ludger Klimek An den Quellen 10 65183 Wiesbaden Phone:0611-8904381 Fax:0611-3082360 Monitoring,data management and statistical evaluation: IMSIE- Institut for medical statistics,computer sciences and epidemiology University hospital Cologne Lindenburger Allee 42 50931 Cologne Phone:0221-4783456 Fax:0221-4783465

Nyckelord

Versioner (1)
  1. 2016-01-27 2016-01-27 -
Uppladdad den

27 januari 2016

DOI

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Creative Commons BY-NC 3.0
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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis SAE report form

Engelsk

Serious Adverse Event report form

1 Formulär  
SAE report form
Beskrivning

SAE report form

Please give Patient ID composed of Study site Nr and Patient Nr
Beskrivning

Patient Identification

Datatyp

integer

Alias
UMLS CUI [1]
C1269815
Patient date of birth
Beskrivning

Birthdate

Datatyp

date

Alias
UMLS CUI [1]
C0421451
At which visit has the SAE occurred?
Beskrivning

Visit number

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Patient Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Body Height
Beskrivning

Body Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body Weight
Beskrivning

Body Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Observed SAE
Beskrivning

Observed SAE

When did the SAE occur? Please note day/month/year
Beskrivning

Date of occurrence

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2697887
Please describe anything relevant to this specific event: clinically relevant findings,laboratory results, medical history and comorbidities
Beskrivning

Description of SAE

Datatyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Opinion of investigator
Beskrivning

Opinion of investigator

Applied medication with lot number, please include also the investigational product.
Beskrivning

Medication

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Daily dose of medication
Beskrivning

Daily dose

Datatyp

float

Alias
UMLS CUI [1]
C2348070
Drug application route (i.e: i.v, s.c, i.m,oral,...)
Beskrivning

Drug application route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Medication use start date
Beskrivning

Medication use start date

Datatyp

date

Alias
UMLS CUI [1,1]
C0240320
UMLS CUI [1,2]
C0808070
Medication use end date
Beskrivning

Medication use end date

Datatyp

date

Alias
UMLS CUI [1,1]
C0240320
UMLS CUI [1,2]
C0806020
Is the SAE related to the pharmaceutical product?
Beskrivning

SAE Context

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0041755
Outcome and treatment
Beskrivning

Outcome and treatment

Lifethreatening adverse event
Beskrivning

Lifethreatening

Datatyp

boolean

Alias
UMLS CUI [1]
C1517874
Event resulted in a hospitalization
Beskrivning

Hospitalization

Datatyp

boolean

Alias
UMLS CUI [1]
C0019993
Date of hospital admission
Beskrivning

Date of hospital admission

Datatyp

date

Alias
UMLS CUI [1]
C0806429
Please describe treatment (i.e chronological sequence, determining factors, discontinuation of medication, clinical condition of the patient at this point)
Beskrivning

Treatment methods

Datatyp

text

Alias
UMLS CUI [1]
C0679624
Please describe any attached documents (hospital report, lab results or other tests contributing to the diagnosis)
Beskrivning

Attached documents

Datatyp

text

Alias
UMLS CUI [1]
C1999228
What ist the result of the reported SAE?
Beskrivning

Patient outcome

Datatyp

text

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C1519255
Death related to Serious Adverse Event
Beskrivning

Death Related to Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1]
C1705232
Death of the patient is not related to the trial substance
Beskrivning

Death context to trial substance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2983596
UMLS CUI [1,2]
C0041755
Date of completion of this form
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Tillbaka till toppen

Similar models

Serious Adverse Event report form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
SAE report form
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Birthdate
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Visit number
Item
At which visit has the SAE occurred?
integer
C1549755 (UMLS CUI [1])
Item
Patient Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Patient Gender
CL Item
Female (1)
CL Item
Male (2)
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Item Group
Observed SAE
Date of occurrence
Item
When did the SAE occur? Please note day/month/year
date
C0011008 (UMLS CUI [1,1])
C2697887 (UMLS CUI [1,2])
Description of SAE
Item
Please describe anything relevant to this specific event: clinically relevant findings,laboratory results, medical history and comorbidities
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Opinion of investigator
Medication
Item
Applied medication with lot number, please include also the investigational product.
text
C0013227 (UMLS CUI [1])
Daily dose
Item
Daily dose of medication
float
C2348070 (UMLS CUI [1])
Drug application route
Item
Drug application route (i.e: i.v, s.c, i.m,oral,...)
text
C0013153 (UMLS CUI [1])
Medication use start date
Item
Medication use start date
date
C0240320 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication use end date
Item
Medication use end date
date
C0240320 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Is the SAE related to the pharmaceutical product?
text
C0013227 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
SAE Context
Code List
Is the SAE related to the pharmaceutical product?
CL Item
no correlation (1)
CL Item
unlikely  (2)
CL Item
possible (3)
CL Item
confirmed (4)
CL Item
inconclusive/insufficent data (5)
Item Group
Outcome and treatment
Lifethreatening
Item
Lifethreatening adverse event
boolean
C1517874 (UMLS CUI [1])
Hospitalization
Item
Event resulted in a hospitalization
boolean
C0019993 (UMLS CUI [1])
Date of hospital admission
Item
Date of hospital admission
date
C0806429 (UMLS CUI [1])
Treatment methods
Item
Please describe treatment (i.e chronological sequence, determining factors, discontinuation of medication, clinical condition of the patient at this point)
text
C0679624 (UMLS CUI [1])
Attached documents
Item
Please describe any attached documents (hospital report, lab results or other tests contributing to the diagnosis)
text
C1999228 (UMLS CUI [1])
Item
What ist the result of the reported SAE?
text
C1547647 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Patient outcome
Code List
What ist the result of the reported SAE?
CL Item
Recovered (1)
CL Item
Recovered with persisting sequelae (2)
CL Item
Continuing  (3)
CL Item
Unknown (4)
CL Item
Lethal (5)
Death Related to Adverse Event
Item
Death related to Serious Adverse Event
boolean
C1705232 (UMLS CUI [1])
Death context to trial substance
Item
Death of the patient is not related to the trial substance
boolean
C2983596 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Tillbaka till toppen 

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