. "seriousAdverseOutcome" . . . . "A possible serious complication and/or serious side effect of this therapy. Serious adverse outcomes include those that are life-threatening; result in death, disability, or permanent damage; require hospitalization or prolong existing hospitalization; cause congenital anomalies or birth defects; or jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes in this definition." .