Table 1 Definition of serious and specific serious adverse events

• Event leads to hospital admission

• Event leads to extension of the inpatient stay

• Event leads to death

• Event results in permanent damage

• Event prompts the treating physicians to discontinue a medication

• Hypertension with blood pressure values > 200 mmHg systolic or > 120 mmHg diastolic

• Collapse, if accompanied by actual sudden falling

• Cardiac arrhythmias or conduction disorders:

- If they lead to transfer to an internal medicine department

- If they are considered severe from an internal medicine perspective

- If QT interval prolongation > 470 ms in women, > 450 ms in men

- If there is an increase of > 60 ms after the start of treatment

- Tachycardia with a heartrate of > 120 beats per minute or clinical symptoms

• Agranulocytosis, with granulocytes < 500 cells/μl

• Neutropenia, with neutrophils < 1500 cells/μl

• Leukopenia, with leukocytes < 3000 cells/μl