Table 2. Evaluation of Serious Adverse Reactions (SARs).
SAR severity | Comments |
---|---|
Unimportant | No damage, no risk, the patient is not informed as there is no risk of damage |
Non-severe | Mild clinical/psychological consequences |
There is no hospitalization | |
No long-term consequences/disabilities expected | |
Severe | Hospitalization or prolongation of hospitalization or permanent or significant disability or incapability |
Intervention for permanent damage exclusion | |
Sign of serious transmissible disease | |
Birth of a child with severe genetic disease after ART with germ cells or embryo from donor | |
Life-threatening | Notable intervention to prevent death |
Evidence of life-threatening transmissible disease | |
Birth of a child with life-threatening genetic disease after ART with germ cells or embryo from donor | |
Death | Death |
Source: ARTHIQS [14].