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Clinical trials for Serious adverse events

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44347   clinical trials with a EudraCT protocol, of which   7375   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    3,947 result(s) found for: Serious adverse events. Displaying page 1 of 198.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2019-001402-20 Sponsor Protocol Number: D910FC00001 Start Date*: 2019-11-27
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)
    Medical condition: Various types of cancer ( dependent on parent study)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10049280 Solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FR (Completed) DE (Completed) HU (Completed) PL (Completed) ES (Ongoing) GR (Completed) BE (Completed) BG (Completed) IT (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-002218-38 Sponsor Protocol Number: GQM10 Start Date*: 2019-07-04
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Safety of a Quadrivalent Influenza Vaccine (VaxigripTetraTM) in Subjects Aged 6 Months and Older in Vietnam
    Medical condition: Prophylaxis of influenza in healthy volunteers (6 months and older)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004588-11 Sponsor Protocol Number: ABR64005 Start Date*: 2019-09-10
    Sponsor Name:University Maastricht
    Full Title: Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease.
    Medical condition: The chronic inflammatory bowel disease Crohn's disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-000686-35 Sponsor Protocol Number: CLIC477D2302E01 Start Date*: 2005-04-29
    Sponsor Name:Novartis Pharma AG
    Full Title: A 52-week open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2000 mg/d in the treatment of manic episodes of bipolar I disorder
    Medical condition: Bipolar I disorder, manic and mixed episodes
    Disease:
    Population Age: Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001758-32 Sponsor Protocol Number: 20140114 Start Date*: 2017-08-29
    Sponsor Name:Amgen, Inc.
    Full Title: Long-term Safety Follow-up of Subjects With Giant Cell Tumour of Bone Treated With Denosumab in Study 20062004
    Medical condition: Giant Cell Tumour of Bone
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003608-61 Sponsor Protocol Number: ZLB06_002CR Start Date*: 2015-01-05
    Sponsor Name:CSL Behring
    Full Title: A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
    Medical condition: Primary Immune Deficiency
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-000687-27 Sponsor Protocol Number: CLIC477D2303E01 Start Date*: 2004-11-19
    Sponsor Name:Novartis Pharma AG
    Full Title: A 52 week open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2500 mg/d in the treatment of manic episodes of bipolar I disorder
    Medical condition: Bipolar I disorder, manic and mixed episodes DSM-IV criteria 296.0, 296.4 or 296.6
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Prematurely Ended) SK (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2023-000765-14 Sponsor Protocol Number: 217270 Start Date*: 2023-10-03
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A prospective, multi-center post marketing surveillance (PMS) study to monitor the safety of GlaxoSmithKline Biologicals’ SA’s (GSK) Meningococcal Group B (Bexsero) vaccine in Korean participants, ...
    Medical condition: The study will collect real-world post-vaccination adverse events.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-004686-13 Sponsor Protocol Number: LAS-212 Start Date*: 2020-05-01
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement o...
    Medical condition: Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver transplantation
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002476-92 Sponsor Protocol Number: 20120215 Start Date*: 2015-06-29
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidatio...
    Medical condition: Patients with Philadelphia chromosome negative (Ph-) high-risk (HR) first relapse B-precursor ALL (as defined by I-BFM SG/IntReALL criteria)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    21.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    21.1 100000004864 10066109 Precursor B-lymphoblastic leukemia acute LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BE (Completed) IT (Completed) SE (Completed) PT (Completed) DK (Completed) AT (Completed) GB (GB - no longer in EU/EEA) PL (Completed) ES (Ongoing) FR (Completed) NL (Completed) Outside EU/EEA GR (Completed) NO (Completed) HU (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2019-004459-35 Sponsor Protocol Number: MET41 Start Date*: 2020-02-12
    Sponsor Name:Sanofi Pasteur Inc
    Full Title: A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers
    Medical condition: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-019218-26 Sponsor Protocol Number: ANA-ALS01 Start Date*: 2010-12-06
    Sponsor Name:Charité - University Hospital of Berlin
    Full Title: Offene Verträglichkeitsstudie zur Evaluierung einer subkutanen Injektionslösung von 100 mg Anakinra in Kombination mit Riluzol bei Patienten mit Amyotropher Lateralsklerose (ALS).
    Medical condition: Amyotophic lateral sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002803-42 Sponsor Protocol Number: 15.05.2007 Start Date*: 2008-03-05
    Sponsor Name:Univ.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, Austria
    Full Title: Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial
    Medical condition: Pulmonary arterial hypertension (PAH) is associated with poor prognosis.The most common cause of death is right heart failure. The fact that right heart failure is associated with low systemic per...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003520-37 Sponsor Protocol Number: D081DC00008 Start Date*: 2014-02-04
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatmen...
    Medical condition: metastatic castrate-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) NL (Completed) CZ (Completed) ES (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-000545-19 Sponsor Protocol Number: HA008 Start Date*: 2006-08-03
    Sponsor Name:Nuvelo, Inc.
    Full Title: Phase 3, Multicenter, Multi-National, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects with Occluded Central Venous Access Devices
    Medical condition: Central venous access device withdrawl occlusion
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051149 Catheter occlusion LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-000133-12 Sponsor Protocol Number: SBR-ITA13 Start Date*: 2013-07-20
    Sponsor Name:Azienda Ospedaliera Universitaria Integrata Verona
    Full Title: A randomized controlled multicentre open-label parallel arm study to assess the non-inferiority of the safety of bevacizumab compared to ranibizumab (allocation 4:1) administered by intravitreal in...
    Medical condition: - Age-related macular degeneration - Diabetic retinal oedema - Retinal perivascular sheathing - Choroidal neovascularisation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-001117-13 Sponsor Protocol Number: C3BS-C-11-01 Start Date*: 2012-11-14
    Sponsor Name:Celyad SA
    Full Title: Efficacy and Safety of Bone Marrow-Derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the Treatment of Chronic Advanced Ischemic Heart Failure
    Medical condition: Chronic advanced symptomatic heart failure secondary to ischemic cardiomyopathy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004849 10010684 Congestive heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) HU (Completed) PL (Completed) SE (Completed) ES (Completed) IE (Completed) BG (Completed) LT (Completed) EE (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2020-006141-19 Sponsor Protocol Number: UMCG-RR#202000930 Start Date*: 2021-05-21
    Sponsor Name:University Medical Center Groningen
    Full Title: Fluorescence guided surgery for intra-operative detection of meningioma using Bevacizumab-IRDye800CW
    Medical condition: meningioma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027191 Meningioma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-000713-11 Sponsor Protocol Number: CV149-208 Start Date*: 2007-07-20
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: An Exploratory, Multi-center, Open-Label, Single-Arm study to evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers i...
    Medical condition: Biomarkers of inflammation and platelet activation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058542 Anti-platelet antibody LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003054-24 Sponsor Protocol Number: B1851172 Start Date*: 2019-04-16
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 3, Multicenter, Single-arm, Open-label Study To Assess The Safety, Tolerability, And Immunogenicity Of A Single Dose Of 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 ...
    Medical condition: Pneumococcal Infections
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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