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Clinical trials for 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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    13,023 result(s) found for: Adverse events. Displaying page 1 of 652.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2021-002073-26 Sponsor Protocol Number: 1125-ECIR Start Date*: Information not available in EudraCT
    Sponsor Name:Medical Center - University of Freiburg
    Full Title: Phase 1/2 Trial to determine the safety and efficacy of Extracorporeal photopheresis as treatment for steroid-refractory immune related adverse events after immune checkpoint inhibitor therapy
    Medical condition: Immune related adverse events induced by treatment with immune checkpoint inhibitors (monoclocanl antibodies against PD-1, PD-L1 or CTLA-4)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10022117 - Injury, poisoning and procedural complications 10043408 Therapeutic agent toxicity LLT
    26.1 10018065 - General disorders and administration site conditions 10067033 Drug side effect LLT
    24.0 10018065 - General disorders and administration site conditions 10061623 Adverse drug reaction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    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: 2014-002834-30 Sponsor Protocol Number: 20120328 Start Date*: 2015-07-14
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects in Europe With Unresected Stage IIIB to IVM1c Melanoma
    Medical condition: Unresectable, Stage IIIB to IVM1c Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10053571 Melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004984-11 Sponsor Protocol Number: P150962J Start Date*: 2018-07-06
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: "Study of maintenance of the efficacy and adverse effects of pharmacological treatments in sex offenders with paraphilia" ESPARA
    Medical condition: Sexual offenders with paraphilia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10033888 Paraphilia PT
    Population Age: Adults Gender: Male
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001761-11 Sponsor Protocol Number: 300488 Start Date*: 2015-08-31
    Sponsor Name:The Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
    Full Title: Lymphatic dysfunction as a cause of calcium channel blocker oedema in post-menopausal women
    Medical condition: Calcium channel antagonist induced peripheral edema in post-menopausal women. We hypothesize that this condition is partly due to impaired lymphatic function in these patients.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004867 10067033 Drug side effect LLT
    18.0 100000004867 10034570 Peripheral edema LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2012-002622-75 Sponsor Protocol Number: 2013 Start Date*: 2013-05-21
    Sponsor Name:Vibeke Hjortdal
    Full Title: Lymphatic dysfunction as a cause of calcium channel blocker oedema
    Medical condition: Fluid accumulation in the leg associated with calcium channel blocker therapy.
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004867 10067033 Drug side effect LLT
    16.0 100000004867 10034570 Peripheral edema LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    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: 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: 2008-004443-11 Sponsor Protocol Number: A5361022 Start Date*: 2009-02-04
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A 52-WEEK OPEN-LABEL SAFETY STUDY OF PD 0332334 IN SUBJECTS WITH GENERALIZED ANXIETY DISORDER
    Medical condition: Generalized Anxiety Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018105 Generalized anxiety disorder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-001361-18 Sponsor Protocol Number: CERL080ABE01 Start Date*: 2004-09-28
    Sponsor Name:Novartis Pharma N.V.
    Full Title: Conversion trial from Cellcept® (MMF) to myfortic® (enteric-coated MPA) in stable transplanted patients suffering from GI adverse events while on Cellcept® therapy.
    Medical condition: liver or kidney transplant - stable
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    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: 2020-001276-15 Sponsor Protocol Number: PI2020_843_0027 Start Date*: 2020-06-18
    Sponsor Name:CHU Amiens-Picardie
    Full Title: Does high-dose vitamin B3 supplementation prevent major adverse kidney events during septic shock? A multicenter randomized controlled study.
    Medical condition: adverse kidney events during septic shock
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    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: 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: 2007-000789-19 Sponsor Protocol Number: MiniCept Start Date*: 2007-05-30
    Sponsor Name:CHU de Liège, Domaine Universitaire du Sart Tilman
    Full Title: Withdrawal of Calcineurin Inhibitors (CNIs) during administration of Mycophenolate Mofetil (MMF) in liver transplant patients suffering adverse effects from CNIs: Study of the reduction in rejectio...
    Medical condition: liver transplant patients suffering adverse effects from treatment with calcineurin inhibitors
    Disease: Version SOC Term Classification Code Term Level
    9.1 10050434 Prophylaxis against liver transplant rejection LLT
    9.1 10054980 Immunosuppressant drug therapy LLT
    9.1 10052538 Adverse drug reaction NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    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: 2009-017051-10 Sponsor Protocol Number: 09-313 Start Date*: 2010-07-13
    Sponsor Name:UMC Utrecht
    Full Title: Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis
    Medical condition: Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher. Patients will be e...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10060732 Rheumatoid arthritis flare up LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000253-29 Sponsor Protocol Number: IC51-303 Start Date*: 2005-08-01
    Sponsor Name:Intercell AG
    Full Title: LONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY
    Medical condition: Japanese encephalitis. This study is a follow-up to the pivotal immunogenicity and safety studies IC51-301 and IC51-302.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-011774-15 Sponsor Protocol Number: BASt01 Start Date*: 2009-07-15
    Sponsor Name:Federal Highway Research Institute / Bundesanstalt für Straßenwesen (BASt)
    Full Title: Effects of opioid analgesics on driving ability of pain patients [Untersuchung zur Fahrsicherheit von Schmerzpatienten]
    Medical condition: patients suffering from chronic non-cancer pain responsive to opioid analgesics under already existing long-term treatment
    Disease: Version SOC Term Classification Code Term Level
    11.0 10067033 LLT
    9.1 10013496 Disturbance in attention LLT
    9.1 10027375 Mental impairment (excl dementia and memory loss) HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    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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