Clinical trials: Surveillance
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Multiple Myeloma
Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
This study is to assess the safety and effectiveness of Elranatamab in the real-world clinical settings for the treatment of patients with multiple myeloma in Korea.
- Trial name
- NCT06581848
- Testing
- Elranatamab
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Pfizer
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Surveillance
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with…
- Trial name
- NCT01964950
- Where
- Japan
- Volunteers
- 1,101 people
- Sponsor
- Takeda
Osteoarthritis, Arthritis
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head
- Trial name
- NCT02196818
- Testing
- Mpact Acetabular Shell
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Chronic Kidney Disease
Forxiga CKD Japan Post-Marketing Surveillance (PMS)
To capture safety when Forxige is administrated to CKD patients in the real world setting
- Trial name
- NCT05306210
- Where
- 46 sites in Japan
- Volunteers
- 1,029 people
- Sponsor
- AstraZeneca
Acute Myeloid Leukemia (AML)
Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML .
- Trial name
- NCT04826523
- Where
- 10 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- AbbVie
Non-Small-Cell Lung Carcinoma
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
This is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of Tabrecta® (Capmatinib) in real world setting.
- Trial name
- NCT05703516
- Testing
- Capmatinib
- Where
- 10 sites in South Korea
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 2
Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
The aim of this study is to assess the safety and effectiveness of Rybelsus initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions.
- Trial name
- NCT05714683
- Testing
- Semaglutide
- Volunteers
- 600 people
- Sponsor
- Novo Nordisk A/S
Multiple Myeloma
Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea
PMS period: 09Jun2017 ~ 08Jun2023 Target no.: 600patients indication: POMALYST in combination with dexamethasone is indicated in the treatment of patients with relapsed and refractory multiple myeloma who have received at least…
- Trial name
- Pomalyst PMS (NCT03288974)
- Testing
- POMALYST® (Pomalidomide)
- Where
- 33 sites in South Korea
- Volunteers
- 397 people
- Sponsor
- Celgene
Macular Degeneration
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan
The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function…
- Trial name
- NCT01756261
- Testing
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Where
- Japan
- Volunteers
- 757 people
- Sponsor
- Bayer
Chronic Obstructive Pulmonary Disease
Post Marketing Surveillance of Roflumilast in Korea
The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.
- Trial name
- NCT02068456
- Testing
- Roflumilast
- Where
- South Korea
- Volunteers
- 1,837 people
- Sponsor
- AstraZeneca
Asthma
Arnuity® Ellipta® Drug Use Investigation
The aim of this post-marketing investigation is to collect and assess the information about safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as "Arnuity") in daily clinical practice.
- Trial name
- NCT03184480
- Testing
- Arnuity Ellipta
- Where
- 2 sites in Japan
- Volunteers
- 336 people
- Sponsor
- GlaxoSmithKline
Rhinitis, Allergic, Perennial
Postmarketing Surveillance to Investigate the Safety and Efficacy Information of Alesion® Tablet
Study to investigate the safety and efficacy information of Alesion® Tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria…
- Trial name
- NCT02238223
- Testing
- Alesion®
- Volunteers
- 2,001 people
- Sponsor
- Boehringer Ingelheim
Advanced Heart Failure
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04915924
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 22 sites in South Korea
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
Alzheimer's Disease
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-
The purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease in clinical practice: cognitive function, Functional Assessment Staging…
- Trial name
- NCT01129596
- Testing
- donepezil hydrochloride
- Where
- 722 sites in Japan
- Volunteers
- 10,238 people
- Sponsor
- Eisai Co., Ltd.
Yellow Fever
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
- Trial name
- NCT03541694
- Testing
- Stamaril®
- Where
- South Korea
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Rotavirus, Rotavirus Vaccines
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the…
- Trial name
- NCT00353366
- Testing
- Rotarix, Data collection
- Where
- 18 sites in Philippines
- Volunteers
- 1,439 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bipolar Disorder, Schizophrenia
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy)…
- Trial name
- NCT01053429
- Testing
- ziprasidone
- Volunteers
- 3,391 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Chemotherapy-induced Neutropenia
Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran. The primary objective of this study was safety assessment, including the rate of AEs.
- Trial name
- NCT04460079
- Testing
- Peg-filgrastim
- Volunteers
- 654 people
- Sponsor
- Cinnagen
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