Common use of Serious Adverse Experiences (SAE Clause in Contracts

Serious Adverse Experiences (SAE. An SAE is defined as any AE occurring that results in any of the following outcomes:  death  a life-threatening adverse experience  inpatient hospitalization or prolongation of existing hospitalization  a persistent or significant disability/incapacity  a congenital anomaly/birth defect Other important medical events may also be considered an SAE when, based on appropriate medical judgment, they jeopardize the subject or require intervention to prevent one of the outcomes listed.

Serious Adverse Experiences (SAE. An SAE is defined as any AE occurring that results in any of the following outcomes:  • death  • a life-threatening adverse experience  • inpatient hospitalization or prolongation of existing hospitalization  • a persistent or significant disability/incapacity  • a congenital anomaly/birth defect Other important medical events may also be considered an SAE when, based on appropriate medical judgment, they jeopardize the subject or require intervention to prevent one of the outcomes listed.

Serious Adverse Experiences (SAE. ‌ An SAE is defined as any AE occurring that results in any of the following outcomes:  ▪ death  ▪ a life-threatening adverse experience  ▪ inpatient hospitalization or prolongation of existing hospitalization  ▪ a persistent or significant disability/incapacity  ▪ a congenital anomaly/birth defect Other important medical events may also be considered an SAE when, based on appropriate medical judgment, they jeopardize the subject or require intervention to prevent one of the outcomes listed.

Serious Adverse Experiences (SAE. ‌ An SAE is defined as any AE occurring that results in any of the following outcomes:   death   a life-threatening adverse experience   inpatient hospitalization or prolongation of existing hospitalization   a persistent or significant disability/incapacity   a congenital anomaly/birth defect Other important medical events may also be considered an SAE when, based on appropriate medical judgment, they jeopardize the subject or require intervention to prevent one of the outcomes listed.