Clinically significant definition

Clinically significant means changes that are not only measurable on formal testing, but which correspond to reports from the patient and/or others relating to performance in a range of tasks. The magnitude of change must be large enough to impact on functioning to qualify for this criterion.

Clinically significant means effects, results, or consequences that materially affect or are likely to affect an individual’s mental, physical, or psychosocial well-being, either positively, by preventing a condition or reducing a risk, or negatively, by exacerbating, causing, or contributing to a symptom, illness, or decline in status.

Clinically significant means sufficient to impair substantially a person's judgment, behavior, capacity to recognize, or ability to cope with the ordinary demands of life.

Examples of Clinically significant in a sentence

• Clinically significant abnormal findings should be recorded as medical history.

• Clinically significant weight gain was observed across all baseline body mass index (BMI) categories.

• Clinically significant abnormal laboratory values occurring during the clinical study will be followed until repeat tests return to normal, stabilize, or are no longer clinically significant.

• Clinically significant features including the implication of the kinetic data for the dosage regimen especially for patients at risk, and differences between man and animal species used in the pre clinical studies, shall be described.

• Clinically significant abnormal values will be captured as medical history.

• Clinically significant changes should be recorded in the source and on the eCRF as an AE.

• Clinically significant inaccurate localization of lesions with PET/CT: frequency in 300 patients.

• Clinically significant abnormal laboratory findings are considered AEs, however abnormal laboratory findings may not be considered as AEs if there is no change compared to baseline values (at randomisation).

• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.

• Clinically significant depressive symptoms as a risk factor for HIV infection among black MSM in Massachusetts.

More Definitions of Clinically significant

Clinically significant means sufficient to warrant ongoing management, which may involve regular visits (for example, at least monthly), to a psychiatrist, counsellor or general practitioner;

Clinically significant means a finding or information would have the effect of changing a patient’s diagnosis or treatment plan.

Clinically significant means for the purposes of this coverage, sufficient to substantially impair a person’s judgment, behavior, capacity to recognize, or ability to cope with the ordinary demands of life.