Food and Drug Administration Analysis of Ticagrelor: Using Data From an Enriched Trial to Evaluate Benefit-Risk Difference in an Unstudied Population.
From Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs (T.-Y.M., M.B., N.S.), and Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences (J.L.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD. tzu-yun.mcdowell@fda.hhs.gov.
Tzu-Yun
TY
McDowell
From Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs (T.-Y.M., M.B., N.S.), and Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences (J.L.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Melanie
M
Blank
From Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs (T.-Y.M., M.B., N.S.), and Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences (J.L.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
John
J
Lawrence
From Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs (T.-Y.M., M.B., N.S.), and Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences (J.L.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Norman
N
Stockbridge
D000241:Adenosine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000066491:Clinical Decision-Making; D017277:Drug Approval; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D058921:Purinergic P2Y Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D055502:Secondary Prevention / Q000379:methods*; D000077486:Ticagrelor; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000077486:Ticagrelor; D000241:Adenosine
cardiovascular diseases; clinical trial; myocardial infarction; secondary prevention