Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment

Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System

(2022) Yamin Shu et al.   Frontiers in Pharmacology

Structure-guided design and development of cyclin-dependent kinase 4/6 inhibitors: A review on therapeutic implications

(2022) Mohd. Yousuf et al.   INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system

(2022) Yamin Shu et al.   Frontiers in Public Health

CDK4/6 Inhibitor Treatments in Patients with Hormone Receptor Positive, Her2 Negative Advanced Breast Cancer: Potential Molecular Mechanisms, Clinical Implications and Future Perspectives

(2021) Michela Roberto et al.   Cancers

SGLT-2 inhibitors and atrial fibrillation in the Food and Drug Administration adverse event reporting system

(2021) Benedetta Maria Bonora et al.   Cardiovascular Diabetology

Thromboembolic Events with Cyclin-Dependent Kinase 4/6 Inhibitors in the FDA Adverse Event Reporting System

(2021) Emanuel Raschi et al.   Cancers

Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. data

(2021) Ming-Ming Yan et al.   Expert Opinion On Drug Safety

A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system

(2021) Yamin Shu et al.   Expert Opinion On Drug Safety

Risk of venous and arterial thromboembolic events in women with advanced breast cancer treated with CDK 4/6 inhibitors: A systematic review and meta-analysis

(2021) Elena Bolzacchini et al.   THROMBOSIS RESEARCH

Cyclin-dependent kinase 4 and 6 inhibitors for hormone receptor-positive breast cancer: past, present, and future

(2020) Laura M Spring et al.   LANCET

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

(2020) Milo Gatti et al.   European Journal of Preventive Cardiology

Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials

(2020) Kyaw Zin Thein et al.   BREAST CANCER RESEARCH AND TREATMENT

Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE)

(2020) Stephen R. D. Johnston et al.   JOURNAL OF CLINICAL ONCOLOGY

Management of Abemaciclib‐Associated Adverse Events in Patients with Hormone Receptor‐Positive, Human Epidermal Growth Factor Receptor 2‐Negative Advanced Breast Cancer: Safety Analysis of MONARCH 2 and MONARCH 3

(2020) Hope S. Rugo et al.   ONCOLOGIST

Inhibiting CDK4/6 in Breast Cancer with Palbociclib, Ribociclib, and Abemaciclib: Similarities and Differences

(2020) C. Louwrens Braal et al.   DRUGS

Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up

(2019) H. S. Rugo et al.   BREAST CANCER RESEARCH AND TREATMENT

The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor–Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy—MONARCH 2

(2019) George W. Sledge et al.   JAMA Oncology

Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer

(2019) Dennis J. Slamon et al.   NEW ENGLAND JOURNAL OF MEDICINE

Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer

(2018) G N Hortobagyi et al.   ANNALS OF ONCOLOGY

Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3

(2018) Dennis J. Slamon et al.   JOURNAL OF CLINICAL ONCOLOGY

Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

(2018) Freddie Bray et al.   CA-A CANCER JOURNAL FOR CLINICIANS

Abemaciclib inhibits renal tubular secretion without changing glomerular filtration rate

(2018) Jill C. Chappell et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Intestinal Toxicity in Rats Following Administration of CDK4/6 Inhibitors Is Independent of Primary Pharmacology

(2018) Stephane Thibault et al.   MOLECULAR CANCER THERAPEUTICS

MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2− Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy

(2017) George W. Sledge et al.   JOURNAL OF CLINICAL ONCOLOGY

MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer

(2017) Matthew P. Goetz et al.   JOURNAL OF CLINICAL ONCOLOGY

Pseudocirrhosis and liver failure in patients with metastatic breast cancer after treatment with palbociclib

(2016) Raj Vuppalanchi et al.   HEPATOLOGY

Endocrine Therapy for Hormone Receptor–Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline

(2016) Hope S. Rugo et al.   JOURNAL OF CLINICAL ONCOLOGY

Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial

(2016) Massimo Cristofanilli et al.   LANCET ONCOLOGY

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

(2016) Gabriel N. Hortobagyi et al.   NEW ENGLAND JOURNAL OF MEDICINE

Palbociclib and Letrozole in Advanced Breast Cancer

(2016) Richard S. Finn et al.   NEW ENGLAND JOURNAL OF MEDICINE

Efficacy and Safety of Abemaciclib, an Inhibitor of CDK4 and CDK6, for Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Other Solid Tumors

(2016) A. Patnaik et al.   Cancer Discovery

CDK6—a review of the past and a glimpse into the future: from cell-cycle control to transcriptional regulation

(2015) A-S Tigan et al.   ONCOGENE

Illustration of the Weibull Shape Parameter Signal Detection Tool Using Electronic Healthcare Record Data

(2013) Odile Sauzet et al.   DRUG SAFETY

A Signal Detection Method to Detect Adverse Drug Reactions Using a Parametric Time-to-Event Model in Simulated Cohort Data

(2012) Victoria R. Cornelius et al.   DRUG SAFETY

Quantitative signal detection using spontaneous ADR reporting

(2009) A. Bate et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY