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=3,430 Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
Osteoporosis
Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 209; 17 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=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=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=908 Samsca Post Marketing Surveillance Study
Hypervolemic and Euvolemic Hyponatremia
Primary: Safety Measure — 17.37 percentage of AE
N/A N=55 CTAG Dissection/Trauma Post Marketing Surveillance Japan
Thoracic Aortic Aneurysm · Thoracic Aorta Injury · Thoracic Aortic Dissection
Primary: Primary Entry Tear Exclusion — 21; 26; 27; 22 Participants
N/A N=536 XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
Angina · Coronary Occlusion · Coronary Artery Disease
Primary: Number of Participants With Acute Stent Thrombosis (ST) — 0; 0; 0; 0 Participants
N/A N=1,602 Long-term Observation PMS for Afatinib
Carcinoma, Non-Small-Cell Lung
Primary: Incidence of Adverse Drug Reactions (ADRs) — 95.19 Percentage of Participants
N/A N=682 Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Glioblastoma · Glioma · Astrocytoma
Primary: Number of Participants Experiencing Adverse Events (AEs) — 324 participants
N/A N=755 REQUIP RLS Post Marketing Surveillance
Restless Legs Syndrome
Primary: Number of Participants With Any Adverse Event — 44 participants
N/A N=2,029 Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
Non-small Cell Lung Cancer
Primary: Number of Participants With Adverse Drug Reactions — 1858; 518 Participants
N/A N=2,009 XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
Angina · Chronic Coronary Occlusion · Stent Thrombosis
Primary: Number of Participants With Stent Thrombosis (ST) as Per ARC Definition — 6; 2; 6 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=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=1,041 Korean Post-marketing Surveillance for Xeljanz
Rheumatoid Arthritis · Psoriatic Arthritis
Primary: Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) — 261; 148; 40…
N/A N=649 Prevenar13 Post Market Surveillance
Healthy
Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 — 68; 1 participants
N/A N=20 Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO
Hearing Loss, Sensorineural
Primary: Oldenburg Sentence Test — -6.6; -1.1; -3.5 dB — p=<0.001
N/A N=108 Besponsa Post Marketing Surveillance Study
Hematologic Malignancy
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 99; 34 Participants
N/A N=1,258 Post Market Surveillance for Infanrix™
Diphtheria · Acellular Pertussis · Tetanus
Primary: Number of Subjects Reporting Serious Adverse Events — 3 Subjects
Phase 4 N=687 Post Marketing Surveillance for ADACEL™ in South Korea
Diphtheria · Tetanus · Pertussis
Primary: Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ — 168; 1; 68 Participants
N/A N=251 Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan
Acromegaly
Primary: Number of Participants With Treatment-Related Adverse Events — 89; 20 Participants
N/A N=214 Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
Mycoses
Primary: Number of Participants Reporting Adverse Drug Reactions. — 52; 30; 21; 1 Participants
N/A N=4,393 HEPSERA Post Marketing Surveillance
Hepatitis B
Primary: Number of Participants With an Adverse Event — 74 participants
N/A N=3,977 AVODART(Dutasteride) Post-marketing Surveillance(PMS)
Benign Prostatic Hyperplasia · Prostatic Hyperplasia
Primary: Number of Participants With an Adverse Event — 146 participants
N/A N=3,939 Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
Smoking Cessation
Primary: Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. — 377; 336 participants — p=<0.001
N/A N=700 Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ
Major Depressive Disorder
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 80; 3 Participants
N/A N=100 Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
Dura Mater Nick Cut or Tear · Surgery
Primary: Patient's Outcome — 73; 7; 15; 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