Serious adverse event (SAE):

Any unfavourable medical occurrence that is considered serious at any dose if it:

• •         Results in death,

• •         Is life-threatening,

• •         Requires inpatient hospitalisation or prolongation of existing hospitalisation,

• •         Results in persistent or significant disability/incapacity, or

• •         Is a congenital anomaly/birth defect. (see ICH E2A)

An important medical event that may not be immediately life-threatening or result in death or hospitalisation, that may jeopardise the participant or that may require intervention to prevent serious outcomes (see ICH E2A and E19) should generally be considered as serious.