ID

13260

Beschrijving

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

Trefwoorden

Desensitization, Immunologic

27-01-16 27-01-16 -

Geüploaded op

27 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivits Additional Visit

model
Details

Case report form: Additional Visit

StudyEvent: ODM
1. Case report form: Additional Visit

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Additional Visit

Item Group

Additional Visit

Patient Identification

Item

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

integer

C1269815 (UMLS CUI [1])

Blood pressure

Item

Blood pressure measurement

text

C0005823 (UMLS CUI [1])

Heart rate

Item

Heart rate count

integer

C0018810 (UMLS CUI [1])

Body Height

Item

Body Height

integer

C0005890 (UMLS CUI [1])

Body Weight

Item

Body Weight

float

C0005910 (UMLS CUI [1])

Rhinoscopic evaluation

Item

Rhinoscopic evaluation: Edema

text

C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])

Rhinoscopic evaluation

Code List

Rhinoscopic evaluation: Edema

CL Item

none (0)

CL Item

little (1)

CL Item

severe (2)

Rhinoscopic evaluation

Item

Rhinoscopic evaluation: Secretion

text

C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])

Rhinoscopic evaluation

Code List

Rhinoscopic evaluation: Secretion

CL Item

none (0)

CL Item

clear fluid (1)

CL Item

thick mucous (2)

Rhinoscopic evaluation

Item

Rhinoscopic evaluation: Redness

text

C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])

Rhinoscopic evaluation

Code List

Rhinoscopic evaluation: Redness

CL Item

none (0)

CL Item

little (1)

CL Item

severe (2)

Concomitant agent

Item

Has concomitant medication been subject to change?

boolean

C2347852 (UMLS CUI [1])

Concomitant Agent

Item

Please specify any changes of therapy since last visit

text

C2347852 (UMLS CUI [1])

Comorbidities

Item

Have comorbidities changed?

boolean

C0009488 (UMLS CUI [1])

Comorbidities

Item

If comorbidities have changed,please specify any change since last visit

text

C0009488 (UMLS CUI [1])

Safety Laboratory parameter

Item Group

Safety Laboratory parameter

Laboratory results, safety parameter

Item

Please specify measured hemoglobine and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of erythrocytes and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of leucocytes and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of neutrophils and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of eosinophils and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of basophils and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of monocytes and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of lymphocytes and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured hematocrit and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of thrombocytes and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify measured amount of total bilirubin and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify the measured SGPT and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify the measurement of LDH and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify the measurement of creatinine and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Laboratory results, safety parameter

Item

Please specify the measurement of CRP and units used

text

C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])

Diagnosis

Item

Diagnosis based on latest laboratory findings and or current physical examination (please note also as AE)

text

C0011900 (UMLS CUI [1])

Treatment

Item

Please specify further treatment of your patient

text

C0087111 (UMLS CUI [1])

Item Group

Adverse Events

Adverse Event

Item

Please describe the AE

text

C0877248 (UMLS CUI [1])

Adverse Event Start Date

Item

Adverse Event Start Date

date

C2697888 (UMLS CUI [1])

Adverse Event End Date

Item

Adverse Event End Date

date

C2697886 (UMLS CUI [1])

Adverse event occurrence

Item

How often did the event occur?

text

C2697887 (UMLS CUI [1])

Adverse event occurrence

Code List

How often did the event occur?

CL Item

once (1)

CL Item

regularly (2)

CL Item

continuing (3)

Adverse event severity

Item

Please give your opinion to the severity of the AE

text

C1710066 (UMLS CUI [1])

Adverse event severity

Code List

Please give your opinion to the severity of the AE

CL Item

minor (1)

CL Item

moderate (2)

CL Item

severe (3)

Adverse Event Outcome

Item

Adverse Event Outcome

text

C1705586 (UMLS CUI [1])

Adverse Event Outcome

Code List

Adverse Event Outcome

CL Item

Recovered (1)

CL Item

Subsiding (2)

CL Item

Continuing (3)

CL Item

resolved with sequelae (4)

CL Item

increased symptoms (5)

CL Item

fatal (6)

CL Item

unknown (7)

Adverse Event actions taken

Item

What actions have been taken regarding the trial substance?

text

C2826626 (UMLS CUI [1])

Adverse Event actions taken

Code List

What actions have been taken regarding the trial substance?

CL Item

not applicable (1)

CL Item

no adjustment in dose (2)

CL Item

adjustment of dose (3)

CL Item

suspension of treatment (4)

CL Item

discontinuation of treatment (5)

CL Item

other (6)

Adverse event actions taken

Item

What other actions have been taken in response to the AE?

text

C2826719 (UMLS CUI [1])

Adverse event actions taken

Code List

What other actions have been taken in response to the AE?

CL Item

none (1)

CL Item

change of concomitant medication (2)

CL Item

hospitalization/prolonged stay in hospital (3)

CL Item

further therapeutic and diagnostic measures (4)

Adverse event context to trial substance

Item

Is the AE related to the trial substance?

text

C2983596 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])

Adverse event context to trial substance

Code List

Is the AE related to the trial substance?

CL Item

undecided/incomplete (1)

CL Item

inconclusive (2)

CL Item

without context to trial substance (3)

CL Item

unlikely (4)

CL Item

possible (5)

CL Item

probable (6)

CL Item

confirmed (7)

Date

Item

Date of completion of this form

date

C0011008 (UMLS CUI [1])

Signature

Item

Signature

text

C1519316 (UMLS CUI [1])

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