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Clinical trials for Adverse Drug 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   44336   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    5,490 result(s) found for: Adverse Drug Events. Displaying page 28 of 275.
    EudraCT Number: 2015-002177-37 Sponsor Protocol Number: 1321.7 Start Date*: 2016-06-01
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilat...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10066899 Venous thromboembolism LLT
    18.1 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) LT (Completed) CZ (Completed) IT (Completed) DE (Completed) Outside EU/EEA GR (Completed) HU (Completed) BE (Completed) ES (Prematurely Ended) BG (Completed) AT (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-003563-36 Sponsor Protocol Number: ACQUIVAS Start Date*: 2018-07-30
    Sponsor Name:Cambridge University Hospital NHS Foundation Trust and University of Cambridge
    Full Title: ACQUIVAS - Acquired immunodeficiency in ANCA associated vasculitis (AAV)
    Medical condition: Pneumococcal vaccine responses in ANCA associated vasculitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10050894 Anti-neutrophil cytoplasmic antibody positive vasculitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-001071-20 Sponsor Protocol Number: NSC18001 Start Date*: 2018-09-19
    Sponsor Name:Pharmatrophix Inc
    Full Title: A 10-day prospective, single-center, double-blind, placebo-controlled, randomized study to evaluate safety, tolerability and pharmacokinetics of 600 mg b.i.d. oral doses of LM11A-31-BHS in healthy ...
    Medical condition: Mild to moderate Alzheimer's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001896 Alzheimer's disease LLT
    20.0 100000004852 10066571 Progression of Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-000627-53 Sponsor Protocol Number: P150922 Start Date*: 2016-11-18
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: MAINtenance of remission with RITuximab versus azathioprine for patients with newly-diagnosed or relapsing Eosinophilic Granulomatosis with polyangiitis. A prospective, randomized, controlled, doub...
    Medical condition: Patients with newly diagnosed or relapsing EGPA, after achievement of remission.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10009164 Churg Strauss syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004579-11 Sponsor Protocol Number: D3251C00004 Start Date*: 2014-07-11
    Sponsor Name:AstraZeneca
    Full Title: A randomised, double-blind, double dummy, 56 week placebo-controlled, multicentre, parallel group, phase 3 study evaluating efficacy and safety of 3 benralizumab doses in patients with moderate to ...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Completed) BE (Completed) PL (Completed) BG (Completed) FR (Completed) SI (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2020-001029-30 Sponsor Protocol Number: PENTA22-Viiv212968 Start Date*: 2021-08-11
    Sponsor Name:Fondazione Penta ONLUS
    Full Title: A multicenter, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected c...
    Medical condition: HIV-1 infection in children and adolescents with Multi Drug-Resistant virus
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10020447 Human immunodeficiency virus type I infection with other conditions LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004608-39 Sponsor Protocol Number: ITP0511 Start Date*: 2013-05-05
    Sponsor Name:G.I.M.EM.A. Gruppo Italiano Malattie EMatologiche dell'Adulto
    Full Title: Eltrombopag in patients with delayed post transplant thrombocytopenia
    Medical condition: delayed post transplant thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004851 10043555 Thrombocytopenias HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004424-65 Sponsor Protocol Number: 15085MS-AS Start Date*: 2016-05-09
    Sponsor Name:Belfast Health and Social Care Trust
    Full Title: Prevention of post-operative complications by using HMG-CoA Reductase Inhibitor in patients undergoing oesophagectomy - A multicentre, randomised, double blind, placebo controlled trial
    Medical condition: Post-operative complications - Post-operative Pulmonary complication, Acute Respiratory Distress Syndrome and Myocardial Infarction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2008-002560-34 Sponsor Protocol Number: F1J-US-HMFR(b) Start Date*: 2008-09-02
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Duloxetine HCl in Patients with Central Neuropathic Pain Due to Multiple Sclerosis
    Medical condition: Central neuropathic pain due to Multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10054095 Neuropathic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003623-37 Sponsor Protocol Number: CAN-PDP Start Date*: 2020-02-12
    Sponsor Name:King's College London [...]
    1. King's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: CANnabidiol for Parkinson’s Disease Psychosis
    Medical condition: Parkinson's disease psychosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10074835 Parkinson's disease psychosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003485-11 Sponsor Protocol Number: 1002-043 Start Date*: 2017-02-16
    Sponsor Name:Esperion Therapeutics Inc.,
    Full Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at high risk for, Cardi...
    Medical condition: Patients with, or at high risk for, cardiovascular disease (CVD) who are statin intolerant.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10007541 - Cardiac disorders 10007648 Cardiovascular disease, unspecified LLT
    20.0 10007541 - Cardiac disorders 10007649 Cardiovascular disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) NL (Completed) LV (Completed) LT (Completed) GB (GB - no longer in EU/EEA) DK (Completed) DE (Completed) HU (Completed) BG (Completed) CZ (Completed) PL (Completed) ES (Completed) HR (Completed) BE (Completed) AT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2015-003142-51 Sponsor Protocol Number: DCR-PH1-101 Start Date*: 2016-04-11
    Sponsor Name:Dicerna Pharmaceuticals, Inc.
    Full Title: A Phase 1 Study of DCR-PH1 in Patients with Primary Hyperoxaluria Type 1 (PH1)
    Medical condition: Primary Hyperoxaluria Type 1
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038359 - Renal and urinary disorders 10020703 Hyperoxaluria PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-003664-29 Sponsor Protocol Number: EP0156 Start Date*: 2021-04-30
    Sponsor Name:UCB Biopharma SRL
    Full Title: Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IE (Completed) HU (Completed) PL (Completed) CZ (Completed) BE (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000035-50 Sponsor Protocol Number: ACT16146 Start Date*: 2020-08-07
    Sponsor Name:Sanofi aventis recherche & développement
    Full Title: Randomized, open-label, Phase 2 study of SAR408701 combined with pembrolizumab and pembrolizumab alone in patients with CEACAM5 and PD-L1 positive advanced/metastatic non-squamous non–small-cell lu...
    Medical condition: Non-squamous non–small-cell lung cancer (NSQ NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10079440 Non-squamous non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000307-32 Sponsor Protocol Number: 20110264 Start Date*: 2014-11-18
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Me...
    Medical condition: Unresected, Stage IIIB-IV Melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002193-27 Sponsor Protocol Number: COVID-AT Start Date*: 2020-06-15
    Sponsor Name:Cristina Avendano-Sola
    Full Title: Double-blind, randomized, controlled, clinical trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19
    Medical condition: COVID-related Acute Respiratory Distress Syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-001027-11 Sponsor Protocol Number: AS07/1104-001 Start Date*: 2005-06-03
    Sponsor Name:University Hospitals Coventry and Warwickshire NHS Trust
    Full Title: Diabetes in the Very Elderly Trial
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003737-26 Sponsor Protocol Number: A3191342 Start Date*: 2015-04-07
    Sponsor Name:Pfizer Inc
    Full Title: A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile ...
    Medical condition: Juvenile idiopathic arthritis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003523-34 Sponsor Protocol Number: RA101495-01.202 Start Date*: 2017-04-06
    Sponsor Name:Ra Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) HU (Completed) DK (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-003619-23 Sponsor Protocol Number: 6630-4200-42 Start Date*: 2019-11-29
    Sponsor Name:MEDICE Arzneimittel Pütter GmbH & Co. KG
    Full Title: EFFICACY AND SAFETY OF A PARENTERALLY ADMINISTERED FIXED VITAMIN COMBINATION (VITAMIN B6, B12 AND FOLIC ACID) ON VITAMIN B12 STATUS AND METHYLATION CAPACITY IN COBALAMIN DEFICIENCY COMPARED TO ORAL...
    Medical condition: vitamin B12 deficiency
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
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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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