Informações:
Falhas:
ID
13260
Descrição
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
Palavras-chave
Versões (1)
- 27/01/2016 27/01/2016 -
Transferido a
27 de janeiro de 2016
DOI
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Licença
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
Case report form: Additional Visit
- StudyEvent: ODM
Similar models
Case report form: Additional Visit
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
C0178628 (UMLS CUI [1,2])
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])
C0178628 (UMLS CUI [1,2])
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])
C0178628 (UMLS CUI [1,2])
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])
Laboratory results, safety parameter
Item
Please specify measured hemoglobine and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
CL Item
minor (1)
CL Item
moderate (2)
CL Item
severe (3)
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])
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])
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])
C0041755 (UMLS CUI [1,2])
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])