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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis SAE report form - Serious Adverse Event report form

- 27/01/16 - 1 modulo, 4 itemgroups, 24 elementi, 1 linguaggio
Itemgroups: SAE report form, Observed SAE, Opinion of investigator, Outcome and treatment
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivits Additional Visit - Case report form: Additional Visit

- 27/01/16 - 1 modulo, 3 itemgroups, 41 elementi, 1 linguaggio
Itemgroups: Additional Visit, Safety Laboratory parameter, Adverse Events
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis AE report form - Adverse Event report form

- 27/01/16 - 1 modulo, 1 ItemGroup, 13 elementi, 1 linguaggio
ItemGroup: Adverse Events
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Telephone Visit 1 - Case report form: Telephone Visit 1

- 27/01/16 - 1 modulo, 1 ItemGroup, 8 elementi, 1 linguaggio
ItemGroup: Telephone Visit
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Study completion - Case report form Study completion

- 27/01/16 - 1 modulo, 1 ItemGroup, 11 elementi, 1 linguaggio
ItemGroup: Study completion form
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis overall appraisal of treatment - Case Report Form: overall appraisal of treatment

- 26/01/16 - 1 modulo, 3 itemgroups, 7 elementi, 1 linguaggio
Itemgroups: Appraisal by Investigator, Appraisal by patient, Date and Signature
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 14 - Case Report Form Visit 14

- 26/01/16 - 1 modulo, 4 itemgroups, 99 elementi, 1 linguaggio
Itemgroups: Visit 14:Study Completion Visit, Determination of specific IgE and Safety Laboratory parameter, Subcutaneous desensitization, Adverse Events
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 13 - Case Report Form Visit 13

- 26/01/16 - 1 modulo, 3 itemgroups, 50 elementi, 1 linguaggio
Itemgroups: Visit 13:Maintenance Visit, Subcutaneous desensitization, Adverse Events
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 12 - Case Report Form Visit 12

- 25/01/16 - 1 modulo, 3 itemgroups, 51 elementi, 1 linguaggio
Itemgroups: Visit 12:Maintenance Visit, Subcutaneous desensitization, Adverse Events
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 11 - Case Report Form Visit 11

- 25/01/16 - 1 modulo, 3 itemgroups, 52 elementi, 1 linguaggio
Itemgroups: Visit 11:Maintenance Visit, Subcutaneous desensitization, Adverse Events
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 10 - Case Report Form Visit 10

- 25/01/16 - 1 modulo, 3 itemgroups, 53 elementi, 1 linguaggio
Itemgroups: Visit 10:Maintenance Visit, Subcutaneous desensitization, Adverse Events
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

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 9 - Case Report Form Visit 9

- 25/01/16 - 1 modulo, 3 itemgroups, 52 elementi, 1 linguaggio
Itemgroups: Visit 9:Maintenance Visit, Subcutaneous desensitization, Adverse Events
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

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