Table 4.

Definitions of the MDS core outcomes.

Health‐related quality of life	General definition: Quality of life is described ‘as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad‐ranging concept affected in a complex way by the person's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment’ 61
Treatment‐related mortality	Any unexpected cause of death, which cannot be contributed to the disease itself, but can be explained by one of the applied MDS therapeutic interventions. This may include early death after induction or septicaemia due to prolonged cytopenia after drug therapy. The actual cause of death should be specified, if possible. Those deaths which can be explained by other conditions (e.g., stroke, heart attack, other malignancies, suicide, etc.) should be excluded
Overall survival	The length of time from the first MDS diagnosis until death, irrespective of the cause
Performance status	General definition: ‘The performance status describes the status of symptoms and functions with respect to ambulatory status and need for care’ 38
Safety	General definition: Safety can include assessment of the ‘adverse events, laboratory evaluations, vital signs’ 60 , physical examinations, etc.
Haematological improvement	Definition according to the MDS IWG response criteria until the ongoing improvements become available

HMA, hypomethylating agents; IWG, International Working Group; MDS, myelodysplastic syndromes.