Adverse event reporting and harms
death, tumor, voice, congenital anomaly, breathing disorders, nerve damage, paralysis, hematoma, disability
HYPOCALCAEMIA, TUMOR, DISEASE, SPEECH DISORDERS, SWALLOWING DISORDER, POSTOPERATIVE BLEEDING, WOUND INFECTION, ADVERSE EVENT, EVENTS, LYMPHATIC LEAKAGE, EVENTS, HEMATOMA
An adverse event (AE) is any untoward medical occurrence in a patient that does not necessarily have a causal relationship with the study intervention/procedure (thyroidectomy, neck dissection, radioiodine, and rhTSH administration). An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with a trial procedure.A serious adverse event (SAE) is any untoward medical occurrence that at any dose:Is fatal (results in death)Is life-threateningRequires or prolongs inpatient hospitalization*Results in persistent or significant disability / incapacityIs a congenital anomaly / birth defectIs medically significant*** Hospitalization is defined as an unplanned, formal inpatient admission, even if the hospitalization is a precautionary measure for continued observation. Thus hospitalization for protocol treatment, elective procedures (unless brought forward due to worsening symptoms), or social reasons are not regarded as a SAE.** Medical judgment should be exercised in deciding whether an AE is serious in other situations. AEs that are not immediately life-threatening or do not result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the SAE definition above, should be considered serious.Events exclusively related to tumor relapse / progression or treatment of tumor relapse / progressions are not considered as SAE.Adverse events associated with surgery (thyroidectomy, neck dissection) are as follows: hematoma, postoperative bleeding, paralysis of the vocal cord, speech disorders, voice change, swallowing disorders, breathing disorders, hypocalcaemia, lymphatic leakage, wound infection, and nerve damage other than the recurrent nerve.