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Clinical trials for Adverse drug reactions

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    618 result(s) found for: Adverse drug reactions. Displaying page 1 of 31.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2020-005772-35 Sponsor Protocol Number: LINEZOLID01 Start Date*: 2021-04-21
    Sponsor Name:UCLouvain
    Full Title: Study on linezolid use and adverse drug reactions in clinical practice: Follow-up of patients treated in Belgian Hospitals
    Medical condition: All infections treated with the antibiotic linezolid
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    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: 2020-000609-10 Sponsor Protocol Number: 2020-01-GMF-1 Start Date*: 2021-07-06
    Sponsor Name:Center for Surgical Science
    Full Title: A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgery A clinical safety and proof-of-con...
    Medical condition: A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 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: 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: 2010-021874-12 Sponsor Protocol Number: H01_04TP Start Date*: 2010-09-13
    Sponsor Name:Novartis Vaccines Institute for Global Health (NVGH)
    Full Title: A Phase 2, Randomized, Observer–blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the NVGH Glycoconjugate Vaccine against S. Typhi in Adult S...
    Medical condition: Salmonella enterica serovar Typhi (S. Typhi) disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006702-78 Sponsor Protocol Number: BraimTOR-NEURO Start Date*: Information not available in EudraCT
    Sponsor Name:The Children's Memorial Health Institute
    Full Title: Open, randomized, IInd phase clinical study evaluating the safety and efficacy of rapamycin in the treatment of drug-resistant epilepsy in children with rare and ultra-rare diseases of the central ...
    Medical condition: epilepsy, mTORopathies, focal cortical dysplasia, LEATS
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-012297-12 Sponsor Protocol Number: 920134 Start Date*: 2009-08-12
    Sponsor Name:Bioforce AG
    Full Title: Safety and Efficacy of long-term treatment with Echinaforce® over 4 months
    Medical condition: common cold
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2015-004117-24 Sponsor Protocol Number: GETUG-AFU26 Start Date*: 2015-12-24
    Sponsor Name:UNICANCER
    Full Title: A Phase II Safety Trial of Nivolumab in Patients with Metastatic Renal Cell Carcinoma Who Have Progressed During or After Prior Systemic Anti-Angiogenic Regimen
    Medical condition: Patients suffering from refractory metastatic Renal Cell Carcinoma.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10050513 Metastatic renal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-004590-30 Sponsor Protocol Number: R10933-10987-COV-2121 Start Date*: 2022-09-23
    Sponsor Name:Regeneron Pharmaceuticals Inc.
    Full Title: A Phase 2a, Open-Label Study Assessing Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Single-Dose Subcutaneous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab and Imdevim...
    Medical condition: Coronavirus disease 2019
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002900-34 Sponsor Protocol Number: CINE-BENZ Start Date*: 2012-03-07
    Sponsor Name:CRESIB- International Research Center in Health of Barcelona
    Full Title: Population Pharmacokinetics in Benznidazol-treated adults with Chronic Chagas Disease. Benznidazol Pharmacokinetics and adverse reactions relationship.
    Medical condition: The study will be held in 50 patients with Chronic Chagas Disease.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008384 Chagas' disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004363-34 Sponsor Protocol Number: MB 0704/1707/03 Start Date*: 2006-03-30
    Sponsor Name:VALEAS
    Full Title: Antibiotic therapy in children for the upper respiratory tract infections. Study of the ''tollerability profile'' of cefaclor and amoxicillin-clavulanate
    Medical condition: Pharyngitis, Pharyngotonsillitis or Sinusitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057868 Upper respiratory tract infection bacterial LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001745-20 Sponsor Protocol Number: BP11-301 Start Date*: 2023-02-02
    Sponsor Name:CuraTeQ Biologics Private Ltd.
    Full Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BP11 Versus EU-Approved Xolair® in Pati...
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Trial now transitioned) SK (Trial now transitioned) LV (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001959-13 Sponsor Protocol Number: EPICDKL5 Start Date*: 2021-12-02
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Adjunctive cannabidiol therapy in patients with CDKL5 deficiency disorder. Interventional drug study on efficacy and safety with focus on seizure effects
    Medical condition: patients with CDKL5
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10015039 Epilepsy congenital PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    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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