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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   44352   clinical trials with a EudraCT protocol, of which   7379   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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    5,495 result(s) found for: Adverse Drug Events. Displaying page 249 of 275.
    EudraCT Number: 2014-003527-22 Sponsor Protocol Number: CINC424A2X01B Start Date*: 2015-04-30
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: An open label, multi-center, Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study and are judged by the investigator to...
    Medical condition: This roll-over study is designed to accept patients with varied disease origins. Please refer to the parent protocol for the disease background information and rationale for use of ruxolitinib in t...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) DE (Trial now transitioned) GR (Completed) HU (Completed) SE (Trial now transitioned) PT (Completed) BG (Completed) FR (Completed) SK (Completed) DK (Completed) SI (Completed) IT (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003509-72 Sponsor Protocol Number: 20200234 Start Date*: 2021-10-21
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
    Medical condition: Active Systemic Lupus Erythematosus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10025139 Lupus erythematosus systemic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GR (Completed) PL (Prematurely Ended) AT (Completed) BG (Prematurely Ended) ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003666-40 Sponsor Protocol Number: CLI-06001AA1-04 Start Date*: 2021-05-05
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A 52-week, randomized, double-blind, placebo-controlled, parallel-group, study to evaluate the efficacy and safety of two doses of CHF6001 DPI add-on to maintenance triple therapy in subjects with ...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Trial now transitioned) CZ (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) AT (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003639-41 Sponsor Protocol Number: UP0089 Start Date*: 2020-11-06
    Sponsor Name:UCB Biopharma SRL
    Full Title: Phase 1/2A, randomized, placebo-controlled, single-ascending dose (Part A, participant- and investigator-blind) and repeated-dose (Part B, participant-, investigator-, and sponsor-blind) study to i...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) BG (Completed) DE (Completed) ES (Ongoing) BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004168-36 Sponsor Protocol Number: UCL/17/0672 Start Date*: 2018-10-16
    Sponsor Name:University College London
    Full Title: A phase II study of pembrolizumab in patients with advanced gynaecological clear cell cancer
    Medical condition: Advanced Gynaecological Clear Cell Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10048683 Advanced cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009252 Clear cell endometrial carcinoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016180 Fallopian tube cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10046885 Vaginal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10047741 Vulval cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008229 Cervical cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-000186-23 Sponsor Protocol Number: CICL670AIC04 Start Date*: 2016-06-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Open-label, multicenter, single arm, phase III study to collect additional safety and efficacy data with deferasirox film-coated tablets in patients completing study CICL670F2201
    Medical condition: transfusion-dependent thalassemia or myelodysplastic syndrome at very low, low or intermediate (int-1) risk
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054658 Thalassemia LLT
    20.0 100000004864 10028534 Myelodysplastic syndrome NOS LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-000229-23 Sponsor Protocol Number: DGD 44-044 Start Date*: 2007-08-24
    Sponsor Name:GUERBET
    Full Title: RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.
    Medical condition: Patients suffering from renal insufficiency and scheduled for contrast enhanced-MR angiography or unenhanced-MRI
    Disease: Version SOC Term Classification Code Term Level
    10.0 10038474 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-004819-54 Sponsor Protocol Number: PRO051-02 Start Date*: 2008-01-22
    Sponsor Name:Prosensa Therapeutics BV
    Full Title: A phase I/II, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous doses of drisapersen in patients with Duchenne muscul...
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: BE (Completed) NL (Completed) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000946-69 Sponsor Protocol Number: AZ07 Start Date*: 2016-07-05
    Sponsor Name:AZAD Pharma AG
    Full Title: A PHASE III, MULTICENTRE, RANDOMISED, INVESTIGATOR-MASKED, CROSS- OVER, COMPARATIVE CLINICAL TRIAL EVALUATING THE EFFICACY AND SAFETY OF THE GENERIC BRINZOLAMIDE 10 MG/ML + TIMOLOL 5 MG/ML EYE DROP...
    Medical condition: Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction
    Disease: Version SOC Term Classification Code Term Level
    19.0 10015919 - Eye disorders 10018307 Glaucoma and ocular hypertension HLGT
    19.0 10015919 - Eye disorders 10030043 Ocular hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002092-25 Sponsor Protocol Number: 9766 Start Date*: 2018-06-18
    Sponsor Name:University Hospital of Montpellier
    Full Title: A phase 2/3 prospective, multicentre randomized, double-blind trial, comparing intra-discal allogeneic adult BM-MSC therapy and sham-treated controls in subjects with chronic low back pain due to l...
    Medical condition: Degenerative Disc Disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed) DE (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000068-86 Sponsor Protocol Number: AROAAT2002 Start Date*: 2019-07-01
    Sponsor Name:Arrowhead Pharmaceuticals, Inc.
    Full Title: A Pilot Open Label, Multi-dose, Phase 2 Study to Assess the Safety and Efficacy of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)
    Medical condition: alpha-1 antitrypsin deficiency (AATD)-associated liver disease
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004850 10001806 Alpha-1 anti-trypsin deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003808-39 Sponsor Protocol Number: MK-3475-866 Start Date*: 2019-07-01
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Randomized Double Blind Study to Evaluate Peri-operative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-Eligible ...
    Medical condition: Muscle Invasive Bladder Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) IE (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-004665-33 Sponsor Protocol Number: VX06-950-106 Start Date*: 2007-04-04
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2 Study of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects with Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral R...
    Medical condition: Hepatitis C virus (HCV) infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019744 Hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003400-39 Sponsor Protocol Number: NGLU-CL02 Start Date*: 2014-07-15
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase I/II Open Label Study in MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
    Medical condition: Mucopolysaccharidosis III, type B (MPS IIIB), Sanfilippo B
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Temporarily Halted)
    Trial results: View results
    EudraCT Number: 2015-005513-72 Sponsor Protocol Number: B7451006 Start Date*: 2016-07-21
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE AT...
    Medical condition: ATOPIC DERMATITIS
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021428 - Immune system disorders 10021428 Immune system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2006-001958-27 Sponsor Protocol Number: H6D-MC-LVHG Start Date*: 2006-07-13
    Sponsor Name:Lilly ICOS LLC
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men ...
    Medical condition: Primary treatment of the signs and symptoms of benign prostatic hyperplasia in men (also referred to as BPH-LUTS [lower urinary tract symptoms]). BPH-LUTS include urinary frequency, urgency, interm...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000126-22 Sponsor Protocol Number: A18116378 Start Date*: 2012-07-24
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A Single Blind (Sponsor-unblinded), Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of GSK1070806 in the Treatment of Obese Subjects with T2DM.
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002243-42 Sponsor Protocol Number: GCT1021-01 Start Date*: 2016-10-25
    Sponsor Name:Genmab A/S
    Full Title: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax®-AXL-ADC) in patients with solid tumors.
    Medical condition: Cancer of the ovary, cervix, endometrium, anaplastic thyroid, lung (non-small cell lung cancer [NSCLC]) or melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014742 Endometrial neoplasms malignant HLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008342 Cervix carcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10023774 Large cell lung cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10002240 Anaplastic thyroid cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025650 Malignant melanoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039491 Sarcoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014733 Endometrial cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-000051-40 Sponsor Protocol Number: LTS13632 Start Date*: 2013-12-16
    Sponsor Name:Genzyme Corporation
    Full Title: A Long-Term Study to Assess the Ongoing Safety and Efficacy of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
    Medical condition: Patients with acid sphingomyelinase deficiency (Niemann-Pick Type B disease)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10041515 Sphingomyelin lipidosis LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004851-36 Sponsor Protocol Number: 404-201-00012 Start Date*: 2020-08-25
    Sponsor Name:Otsuka Pharmaceutical (OPDC)
    Full Title: Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia ...
    Medical condition: Anemia of Chronic kidney disease (CKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002272 Anemia LLT
    21.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    21.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) CZ (Completed) IT (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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