Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) any laboratory value outside the reference range that the investigator considers to be of clinical relevance any evidence of a concomitant disease assessed as clinically relevant by the investigator gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.

any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) any laboratory value outside the reference range that the investigator considers to be of clinical relevance any evidence of a concomitant disease assessed as clinically relevant by the investigator gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.