blood pressure decreased Cyanosis Shortness of breath Blood pressure decreased Pulmonary embolism Myocardial infarction Chest pain, cyanosis, shortness Congestive heart failure of breath, and blood pressure Chest pain Cyanosis decreased. Differential 4 diagnosis includes pulmonary Shortness of breath embolism, myocardial Blood pressure decreased infarction, and congestive Chest pain heart failure Cyanosis Shortness of breath Blood pressure decreased Always include signs/ Myocardial infarction Myocardial infarction, chest symptoms Jaundice (note that jaundice is pain, dyspnea, diaphoresis, ECG not not typically associated with changes and jaundice associated myocardial infarction) with diagnosis 3.2 Death and Other Patient Outcomes – Death, disability, and hospitalization are considered outcomes in the context of safety reporting and not usually considered ARs/AEs. Outcomes are typically recorded in a separate manner (data field) from AR/AE information. A term for the outcome should be selected if it is the only information reported or provides significant clinical information. (For reports of suicide and self-harm, see Section 3.3). 3.2.1 Death with ARs/AEs Death is an outcome and not usually considered an AR/AE. If ARs/AEs are reported along with death, select terms for the ARs/AEs. Record the fatal outcome in an appropriate data field. Example
blood pressure decreased Cyanosis Shortness of breath Blood pressure decreased 4 Chest pain, cyanosis, shortness of breath, and blood pressure decreased. Differential diagnosis includes pulmonary embolism, myocardial infarction, and congestive heart failure Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased Chest pain Cyanosis Shortness of breath Blood pressure decreased Always include signs/ symptoms not associated with diagnosis Myocardial infarction, chest pain, dyspnea, diaphoresis, ECG changes and jaundice Myocardial infarction Jaundice (note that jaundice is not typically associated with myocardial infarction) 3.2 – Death and Other Patient Outcomes Death, disability, and hospitalization are considered outcomes in the context of safety reporting and not usually considered ARs/AEs. Outcomes are typically recorded in a separate manner (data field) from AR/AE information. A term for the outcome should be selected if it is the only information reported or provides significant clinical information. (For reports of suicide and self-harm, see Section 3.3). 3.2.1 Death with ARs/AEs Death is an outcome and not usually considered an AR/AE. If ARs/AEs are reported along with death, select terms for the ARs/AEs. Record the fatal outcome in an appropriate data field. Example
9491-1510_termselptc_r4_4_sep2012.docx