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Clinical trials for Adverse Drug Event

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    1,553 result(s) found for: Adverse Drug Event. Displaying page 1 of 78.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    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: 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: 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: 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
    EudraCT Number: 2005-003282-16 Sponsor Protocol Number: HA006 Start Date*: 2005-11-04
    Sponsor Name:Nuvelo, Inc.
    Full Title: PHASE 3, MULTICENTER, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALFIMEPRASE IN SUBJECTS WITH OCCLUDED CENTRAL VENOUS ACCESS DEVICES
    Medical condition: Central venous access device occlusion
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003076-14 Sponsor Protocol Number: ANT-007 Start Date*: 2022-05-10
    Sponsor Name:Anthos Therapeutics
    Full Title: A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in ...
    Medical condition: venous thromboembolism (VTE)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Trial now transitioned) NO (Trial now transitioned) FR (Trial now transitioned) IE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) IT (Trial now transitioned) HU (Trial now transitioned) SE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005698-21 Sponsor Protocol Number: EFC11570 Start Date*: 2013-03-05
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recentl...
    Medical condition: Acute coronary syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10007541 - Cardiac disorders 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) BE (Completed) NO (Completed) EE (Completed) LT (Completed) HU (Completed) ES (Completed) CZ (Completed) LV (Completed) DE (Completed) IT (Completed) BG (Completed) FI (Completed) AT (Completed) PT (Completed) DK (Completed) NL (Completed) PL (Completed) SK (Completed) SI (Completed) HR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2020-000688-22 Sponsor Protocol Number: 750203.01.002 Start Date*: 2020-10-16
    Sponsor Name:Dr. Willmar Schwabe GmbH & Co. KG
    Full Title: Multi-centre, double-blind, placebo- and reference-controlled, randomised trial to prove the efficacy and safety of Silexan (WS®1265) in patients with a major depressive episode of mild to moderate...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004873 10083288 Clinical depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-001626-22 Sponsor Protocol Number: RML-TB Start Date*: 2022-03-28
    Sponsor Name:Vall d'Hebron Institute of Research
    Full Title: A Multicentre Controlled Open Randomized Clinical Trial to evaluate the efficacy and safety profile of an anti-TB drug combination based on High Dose Rifampicin, High Dose Moxifloxacin and Linezoli...
    Medical condition: Smear-positive rifampicin-sensitive pulmonary Tuberculosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003085-12 Sponsor Protocol Number: ANT-008 Start Date*: 2022-05-10
    Sponsor Name:Anthos Therapeutics
    Full Title: A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding i...
    Medical condition: venous thromboembolism (VTE) in patients with gastrointestinal/genitourinary cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Trial now transitioned) NO (Trial now transitioned) FR (Trial now transitioned) IE (Trial now transitioned) ES (Ongoing) HU (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) SE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-003956-20 Sponsor Protocol Number: 2003-35-RTA-3 Start Date*: 2005-03-09
    Sponsor Name:HEXAL AG
    Full Title: Multi-center, double-blind, double-dummy, controlled, randomized phase III study on the tolerability and efficacy of Diclofenac Sodium 150 mg o.d. in comparison to Voltaren® 50 t.i.d. and Voltaren®...
    Medical condition: Symptomatic treatment for pain and inflammation associated with irritations of degenerative joint diseases, e.g. ostheoarthitis of the hip, knee or fingers
    Disease: Version SOC Term Classification Code Term Level
    7.1 10031161 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006574-23 Sponsor Protocol Number: AR101-PREVEnt Start Date*: 2022-08-30
    Sponsor Name:Aytu BioPharma, Inc.
    Full Title: A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 ...
    Medical condition: vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014316 Ehlers-Danlos syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Ongoing) BE (Prematurely Ended) FR (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023101-35 Sponsor Protocol Number: CJI-202 Start Date*: 2011-02-11
    Sponsor Name:Sequel Pharmaceuticals Inc.
    Full Title: TUNDRA-AF: A mulTi-center, randomized, doUble-bliNded, placebo-controlled Dose-escalating study of the effects of K201 on the RestorAtion of sinus rhythm in subjects with symptomatic Atrial Fibri...
    Medical condition: Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003130-27 Sponsor Protocol Number: 2015/2294 Start Date*: 2017-05-15
    Sponsor Name:Gustave Roussy
    Full Title: An international multicenter phase II randomized trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chem...
    Medical condition: Very High Risk neuroblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10008126 Cerebral neuroblastoma LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) IT (Prematurely Ended) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) NL (Completed) AT (Prematurely Ended) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004266-35 Sponsor Protocol Number: MAICOVID-19 Start Date*: 2021-12-22
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: A phase 3, multicentre, single-blinded, randomized controlled study to compare the efficacy and safety of Casirivimab and Imdevimab or Bamlanivimab and Etesevimab or Sotrovimab in COVID-19 home pat...
    Medical condition: Mild to moderate COVID-19 patients at high risk of progression to severe COVID-19 and / or hospitalization
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003495-53 Sponsor Protocol Number: NL59009.018.16 Start Date*: 2016-11-29
    Sponsor Name:Academic Medical Center - Cardiology
    Full Title: Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease
    Medical condition: Pulmonary arterial hypertension related to congenital heart disease.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001729-11 Sponsor Protocol Number: CR040301 Start Date*: 2005-02-18
    Sponsor Name:EBEWE Pharma Ges.m.b.H Nfg.KG
    Full Title: A prospective, randomised, placebo controlled, double blind trial about safety and efficacy of combined treatment with Alteplase (rt-PA) and Cerebrolysin in acute ischemic hemispheric stroke
    Medical condition: Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defin...
    Disease: Version SOC Term Classification Code Term Level
    6.0 10055221 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) CZ (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2014-002659-25 Sponsor Protocol Number: C38072-AS-30024 Start Date*: 2016-07-04
    Sponsor Name:Teva Branded Pharmaceutical Products R&D, Inc.
    Full Title: An Open-Label Safety Study of Patients with Severe Eosinophilic Asthma Who Were Previously Enrolled in the Reslizumab Open Label Extension Study C38072/3085
    Medical condition: Treatment for patients with eosinophilic asthma
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10068462 Eosinophilic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-006003-15 Sponsor Protocol Number: E2007-M065-505 Start Date*: 2021-12-27
    Sponsor Name:Eisai Korea Inc.
    Full Title: Post-Marketing Surveillance of Fycompa in Korean Patients
    Medical condition: Partial-onset seizure and primary generalized tonic-clonic seizure
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly 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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