Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Infections

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasms

Blood and Lymph Conditions

Nervous System Diseases

Rare Diseases

Renal Insufficiency

Myocardial Infarction

Infarction

Constipation

Hemorrhage

Syndrome

Hypersensitivity

Lung Diseases

Heart Failure

Multiple Myeloma

Neoplasms, Plasma Cell

Thrombocytopenia

Communicable Diseases

Diarrhea

Arrhythmias, Cardiac

Peripheral Nervous System Diseases

Lung Diseases, Interstitial

Neutropenia

Thromboembolism

Venous Thromboembolism

Tumor Lysis Syndrome

Teratogenesis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

Bristol-Myers Squibb

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths).
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).

A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use

Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use

Number of participants with adverse events

Celgene

Eye Diseases

Digestive System Diseases

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Cataract

Coronary Artery Disease

Liver Diseases

Fatigue

Lymphoma

Leukemia

Heart Diseases

Ischemia

Hypotension

Seizures

Myocardial Ischemia

Vertigo

Dizziness

Leukemia, T-Cell

Sleepiness

Hypothyroidism

Hypotension, Orthostatic

Confusion

Leukemia-Lymphoma, Adult T-Cell

Lymphatic Diseases

Lymphosarcoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance

Revlimid

BMS Study Connect Contact Center www.BMSStudyConnect.com, Study manager

First line of the email MUST contain the NCT# and Site #.

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 referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years
2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Substance Related Disorders

Wounds and Injuries

Prostatic Neoplasms

Atrial Fibrillation

Cardiotoxicity

Tachycardia

Tachycardia, Supraventricular

Cardiac Conduction System Disease

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Androgens

Hormones

Abiraterone Acetate

Androgen Antagonists

Hormone Antagonists

Androgen-deprivation therapies including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones)

L02 (sex hormones used in treatment of neoplastic diseases) and G03 (sex hormones)

Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.

CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other androgen-deprivation therapies are not associated with increased mineral corticosteroid level.

This study investigates reports of cardiovascular toxicities for treatment including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate cancer in the French pharmacovigilance database and in the EudraCT database.

Due to its peculiar pharmacology, abiraterone is potentially associated with more cardiotoxicity as compared to other androgen-deprivation therapies. This study investigates the main characteristics of patients affected by cardiovascular side effects of which supraventricular arrhythmias (including atrial fibrillation, atrial flutter, supraventricular tachycardia), and cardiac failure imputed to drugs classified as L02, and G03 according to anatomical therapeutic chemical (ATC) classification. A causality assessment according to the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied.

cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study

Cardiotoxicity of Abiraterone in the National French Pharmacovigilance Database and in the European Clinical Trials Database (EudraCT)

Analysis of disproportionality of reports for cardiotoxicity associated with abiraterone as compared to enzalutamide by performing a case- non-case study

Compare the reporting of suspected drug-induced supraventricular arrhythmias with abiraterone as compared to enzalutamide by performing a disproportionality analysis

Compare the reporting of drug-induced cardiac failure with abiraterone as compared to enzalutamide by performing a disproportionality analysis

Compare the reporting of drug-induced cardiac failure and/or supraventricular arrhythmias with abiraterone as compared to other androgen-deprivation therapies by performing a disproportionality analysis

Description of other mineralocorticoid related adverse events (hypokaliemia, fluid retention, and hypertension) when the cardio toxicity occurs

Description of the population of patients having a cardio-vascular adverse event

Description of the duration of treatment when the toxicity happens (role of cumulative dose)

Description of the drug-drug interactions associated with adverse events

Causality assessment of reported cardiovascular events according to the WHO-UMC system

Groupe Hospitalier Pitie-Salpetriere

MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use	NCT02922543	Multiple Myelom...		18 Years -	Celgene
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study	NCT03243604	Arrhythmias, Ca... Atrial Fibrilla... Tachycardia, Su... Cardiac Failure	L02 (sex hormon...	18 Years -	Groupe Hospitalier Pitie-Salpetriere
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use	NCT02922543	Multiple Myelom...		18 Years -	Celgene
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study	NCT03243604	Arrhythmias, Ca... Atrial Fibrilla... Tachycardia, Su... Cardiac Failure	L02 (sex hormon...	18 Years -	Groupe Hospitalier Pitie-Salpetriere
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene

Spots Global Cancer Trial Database for cardiac failure