ID

13260

Description

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

Keywords

Versions (1)
  1. 1/27/16 1/27/16 -
Uploaded on

January 27, 2016

DOI

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License

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

English

Case report form: Additional Visit

1 forms  
Additional Visit
Description

Additional Visit

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

Patient Identification

Data type

integer

Alias
UMLS CUI [1]
C1269815
Blood pressure measurement
Description

Blood pressure

Data type

text

Measurement units
  • mm/Hg
Alias
UMLS CUI [1]
C0005823
mm/Hg
Heart rate count
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Body Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Rhinoscopic evaluation: Edema
Description

Rhinoscopic evaluation

Data type

text

Alias
UMLS CUI [1,1]
C0183044
UMLS CUI [1,2]
C0178628
Rhinoscopic evaluation: Secretion
Description

Rhinoscopic evaluation

Data type

text

Alias
UMLS CUI [1,1]
C0183044
UMLS CUI [1,2]
C0178628
Rhinoscopic evaluation: Redness
Description

Rhinoscopic evaluation

Data type

text

Alias
UMLS CUI [1,1]
C0183044
UMLS CUI [1,2]
C0178628
Has concomitant medication been subject to change?
Description

Concomitant agent

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please specify any changes of therapy since last visit
Description

Concomitant Agent

Data type

text

Alias
UMLS CUI [1]
C2347852
Have comorbidities changed?
Description

Comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009488
If comorbidities have changed,please specify any change since last visit
Description

Comorbidities

Data type

text

Alias
UMLS CUI [1]
C0009488
Safety Laboratory parameter
Description

Safety Laboratory parameter

Please specify measured hemoglobine and units used
Description

Please collect every one of the listed parameters below and add units as applicable

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of erythrocytes and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of leucocytes and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of neutrophils and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of eosinophils and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of basophils and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of monocytes and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of lymphocytes and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured hematocrit and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of thrombocytes and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify measured amount of total bilirubin and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify the measured SGPT and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify the measurement of LDH and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify the measurement of creatinine and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please specify the measurement of CRP and units used
Description

Laboratory results, safety parameter

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Diagnosis based on latest laboratory findings and or current physical examination (please note also as AE)
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Please specify further treatment of your patient
Description

Treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Adverse Events
Description

Adverse Events

Please describe the AE
Description

In case of SAE please fill in the SAE-form at the end of this CRF asap (24h) and send via FAX to Roxall Medical GmbH (040/89725223)

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse Event Start Date
Description

Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1]
C2697888
Adverse Event End Date
Description

Adverse Event End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
How often did the event occur?
Description

Adverse event occurrence

Data type

text

Alias
UMLS CUI [1]
C2697887
Please give your opinion to the severity of the AE
Description

Adverse event severity

Data type

text

Alias
UMLS CUI [1]
C1710066
Adverse Event Outcome
Description

Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
What actions have been taken regarding the trial substance?
Description

Adverse Event actions taken

Data type

text

Alias
UMLS CUI [1]
C2826626
What other actions have been taken in response to the AE?
Description

Adverse event actions taken

Data type

text

Alias
UMLS CUI [1]
C2826719
Is the AE related to the trial substance?
Description

Adverse event context to trial substance

Data type

text

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Case report form: Additional Visit

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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)
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)
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])
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])
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)
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)
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)
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)
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)
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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