Clinical trials: Adverse Drug Events
Osteoarthritis
A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule
This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.
- Trial name
- NCT02064634
- Where
- South Korea
- Volunteers
- 6,700 people
- Sponsor
- Green Cross Corporation
Pain
Diclofenac 25mg/Paracetamol 500 mg and Diclofenac 50 mg/Paracetamol 500 mg for Patients With Pain
The purpose of this study is to collect adverse events and identify risk factors in patients that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®
- Trial name
- NCT02651363
- Where
- Peru
- Volunteers
- 374 people
- Sponsor
- Bristol-Myers Squibb
Major Depressive Disorder (MDD)
A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder
Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as…
- Trial name
- NCT06618118
- Testing
- Fosigotifator
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- AbbVie
Stage III Melanoma
Interferon Toxicities in Melanoma Treatment
The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting.
- Trial name
- ITMT (NCT02794636)
- Volunteers
- 436 people
- Sponsor
- Bristol-Myers Squibb
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Epilepsy
Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients
The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment.
- Trial name
- NCT00394927
- Where
- 53 sites in Austria, Czechia and 5 more
- Volunteers
- 1,000 people
- Sponsor
- UCB Pharma
Rheumatoid Arthritis (RA)
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function.
- Trial name
- NCT04888585
- Testing
- ABBV-154
- Where
- 220 sites in United States, Australia and 19 more
- Volunteers
- 473 people
- Sponsor
- AbbVie
Healthy Volunteer
A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese Volunteers
The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese volunteers.
- Trial name
- NCT06632938
- Testing
- ABBV-382
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AbbVie
Acute Coronary Syndrome or B Cerebral Infarction Requiring DAPT(Clopidogrel + Aspirin) for at Least 6 Months
An Observational Study to Evaluate the Incidence of MACCE According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding
This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for…
- Trial name
- NCT05487560
- Testing
- Esomezol Cap
- Where
- South Korea
- Volunteers
- 4,133 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Overactive Bladder
Drug Use-Results Survey of Betanis Tablets in Japan
This study is to determine the following information. 1. The occurrence of adverse drug reactions in clinical settings. 2. Factors potentially impacting safety, effectiveness, and other aspects.
- Trial name
- NCT01919047
- Testing
- Betanis
- Where
- 8 sites in Japan
- Volunteers
- 10,711 people
- Sponsor
- Astellas Pharma Inc
Parkinson Disease
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina…
- Trial name
- NCT04724109
- Testing
- Equfina
- Where
- 2 sites in Japan
- Volunteers
- 1,088 people
- Sponsor
- Eisai Co., Ltd.
Tumor Associated Lymph Node T Cell, Advanced Solid Tumor
A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
A Phase I clinical trial of the safety and tolerability of tumor-associated lymph node T cell injection in patients with advanced malignant solid tumors, including but not limited to melanoma, head and neck tumors, cervical…
- Conditions
- Tumor Associated Lymph Node T Cell, Advanced Solid Tumor, Immunotherapy, Serplulimab Injection
- Trial name
- NCT06716619
- Testing
- Tumor Associated Lymph node T cell, Serplulimab Injection
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
Migraine
Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound.
- Trial name
- NCT04818515
- Testing
- Atogepant, Ubrogepant
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- AbbVie
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Observational Prospective Study OPTIMA II - Follow-up
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study.
- Trial name
- OPTIMAII (NCT02099565)
- Where
- Russia
- Volunteers
- 572 people
- Sponsor
- AstraZeneca
Acute Pain, Dysmenorrhea
Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury.
- Trial name
- NCT02910167
- Testing
- Hyoscine n-butylbromide, Paracetamol
- Where
- Peru
- Volunteers
- 360 people
- Sponsor
- Boehringer Ingelheim
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04339634
- Testing
- Simulation of Repurposed Drugs for COVID-19
- Where
- United States
- Volunteers
- 12,873 people
- Sponsor
- Tabula Rasa HealthCare
Atrial Fibrillation
Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice
This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as…
- Trial name
- SiERRA UK (NCT03847181)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis), Warfarin
- Where
- United Kingdom
- Volunteers
- 45,164 people
- Sponsor
- Bayer
Juvenile Psoriatic Arthritis
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time.
- Trial name
- NCT06100744
- Testing
- Adalimumab, Risankizumab
- Where
- 34 sites in United States, Australia and 7 more
- Volunteers
- 40 people
- Sponsor
- AbbVie
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Trial name
- NCT04770922
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cipherome, Inc.
Oncology
Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.
BAY94-9343 was an antibody-drug conjugate (ADC) directed against the cancer antigen mesothelin on tumor cells.
- Trial name
- NCT01439152
- Testing
- BAY94-9343, BAY94-9343 (Expansion), BAY94-9343 (1.8 mg/kg)
- Where
- 8 sites in United States
- Volunteers
- 148 people
- Sponsor
- Bayer