The following are not considered to be serious adverse events (SAE):
illness or disorder
ADVERSE EVENTS, EVENT, SURGICAL COMPLICATIONS, ADVERSE REACTION, ADVERSE EVENT

A visit to the emergency room or other hospital department for less than 24 h that does not result in admission (unless considered an “important medical event” or a life-threatening event)Outpatient or same-day or ambulatory proceduresObservation or short-stay unitsHospitalization due to diagnostic procedures or standard supportive care (e.g., implant of central venous catheter)A pre-planned hospitalization for a condition which existed at the start of study drug and which did not worsen during the course of study drug treatmentSocial admission (e.g., subject has no place to sleep; hospice facilities)Administrative admission (e.g., for yearly physical examinations)Protocol-specified admission during a clinical trial (e.g., for a procedure required by the study protocol or for clinical research)Optional admission not associated with a precipitating clinical AE (e.g., for elective cosmetic surgery)All adverse events will be evaluated and graded according to the Clavien-Dindo classification of surgical complications (Annex All late serious adverse events (occurring after this period of 30 days) considered to be reasonably related to the study treatment(s) or the research must be declared (no time limit).Information collected in the SAE form is crucial to assess the case. For this reason, diligence in collecting as much verifiable and reliable information is needed: both quality and timeliness are key factors. If known, the diagnosis of the underlying illness or disorder should be recorded, rather than its individual symptoms. The following information should be captured for all SAEs: onset, duration, intensity, seriousness, relationship to study procedure, action taken, and treatment required.The investigator must also attach the following to the serious adverse event report form, wherever possible:A copy of the summary of hospitalization or prolongation of hospitalizationA copy of the post-mortem report (if applicable)A copy of all laboratory examinations and the dates on which these examinations were carried out, including relevant negative results, as well as normal laboratory ranges.All other document that he judges useful and relevant.All these documents will remain anonymous.Further information can be requested (by fax, telephone or when visiting) by the monitor and/or the safety manager.The Pharmacovigilance Unit at IGR will assess the SAE in terms of seriousness, severity (Clavien-Dindo), relationship to the study procedure, and expectedness. All SAEs will be coded using MedDRA.To comply with regulatory requirements, the sponsor will identify and report all SAEs that are related to the study procedures and unexpected (i.e., not described in the protocol). In the European Union, an event meeting these criteria is termed as suspected unexpected serious adverse reaction (SUSAR).