N/A N=135 Absorb GT1 Japan PMS
Ischemic Heart Disease · Angina Pectoris · Coronary Artery Disease
Primary: Number of Participants With Acute Scaffold Thrombosis (ST) — 0; 0; 0 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=189,629 Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
Human Papillomavirus Infection
Primary: Incidence Rate of Syncope — 24.21; 13.84 Rate per 1000 person years
Phase 4 N=1,039 A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
Echocardiography
Primary: The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in…
N/A N=908 Samsca Post Marketing Surveillance Study
Hypervolemic and Euvolemic Hyponatremia
Primary: Safety Measure — 17.37 percentage of AE
N/A N=399 Surveillance of Ocular Surface Flora (SURFACE)
Cataract
Primary: Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid — 51; 48 Percentage of Species
N/A N=36,444 Surveillance Imaging Modalities for Breast Cancer Assessment
Breast Cancer
Primary: Number of Breast Cancers Detected — 279; 27 cancers detected
N/A N=1,779 Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Primary Prevention of Sudden Cardiac Arrest · Secondary Prevention of Sudden Cardiac Arrest
Primary: Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years — 98.9 Percentage of participants
N/A N=1,267 PegIntron Injection Surveillance Plan (Study P04123)
Hepatitis C, Chronic
Primary: Number of Participants That Reported a Serious Adverse Event — 15 Participants
N/A N=472 Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
Gastrointestinal Stromal Tumors
Primary: Number of Participants With Treatment-Related Adverse Events — 450 Participants
N/A N=180 Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
Glioblastoma
Primary: Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed…
N/A N=1,674 Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)
Carcinoma, Renal Cell
Primary: Number of Participants With Treatment-Related Adverse Events — 1599 Participants
N/A N=206 Remote Surveillance of Postpartum Hypertension
Hypertension in Pregnancy
Primary: Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge — 45; 95 Participants
N/A N=41 Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
Breast Cancer
Primary: Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility — 5; 7 Participants
N/A N=116 Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
Meningitis · Meningococcal Infection
Primary: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. — 0.009; 0.006; 0.009; 0.006 Events per 1,000 person-months
N/A N=482 Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
Small for Gestational Age (SGA)
Primary: Number of Participants With Adverse Drug Reaction (ADR) — 24; 4 Participants
N/A N=362 Post Marketing Surveillance Study For Sayana®
Product Surveillance, Postmarketing
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 81; 1 Participants
N/A N=68 Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
CCR5-tropic HIV-1 Infection
Primary: Percentage of Participants With Adverse Drug Reactions (ADRs) — 23.53 percentage of participants
N/A N=595 Surveillance of Kaletra in Korean Patients
HIV-1 Infection
Primary: Number of Participants With Adverse Events — 363; 285 participants
N/A N=620 Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
Gastrointestinal Stromal Tumors
Primary: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected…
N/A N=615 Hepatocellular Carcinoma Surveillance in Cirrhotics
Hepatocellular Carcinoma · Cirrhosis
Primary: HCC Screening Completion — 27.6; 54.5; 54.1 Percentage of participants
N/A N=329 Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
Heart Failure
Primary: Number of Usable Worsening HF Events as Adjudicated by CEC — 69 Adjudicated Events
N/A N=3,337 Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
Pulmonary Hypertension
Primary: Number of Participants With Treatment-Related Adverse Events — 448; 101 Participants
N/A N=100 Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Melanoma (Skin)
Primary: The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial — 100 Participants
N/A N=1,143 Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Pneumococcal Vaccine · Streptococcus Pneumoniae
Primary: Number of Participants With Adverse Reactions — 126 participants
N/A N=617 Surveillance of Synagis in Korean Pediatric Patients
Respiratory Syncytial Virus Infection
Primary: Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) — 126; 3; 46; 3 participants
N/A N=15 Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus)
Coronavirus
Primary: Deterioration Resulting in Healthcare Review — 10 alerts generated
N/A N=39 Melody PB1016 Surveillance Study
Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Primary: Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months — 25 Participants
N/A N=7 Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
Growth & Development · Child Development · Internship and Residency
Primary: Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit — 3 Participants
N/A N=374 Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
Urinary Bladder, Overactive
Primary: Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). — 1; 1; 1 participants
N/A N=436 Hemodialysis Access Surveillance Evaluation Study
Hemodialysis Access · Thrombosis
Primary: Hemodialysis Access Thrombosis Rate — 0.122; 0.227 thrombotic events per patient