Clinically significant definition

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.
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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.
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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.
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Examples of Clinically significant in a sentence

  • Clinically significant laboratory abnormalities will be followed up until they have returned to normal, or a satisfactory explanation has been provided.

  • Clinically significant abnormal laboratory results or other clinically significant assessments will be followed until they resolve (return to normal or baseline values) or stabilize, or until they are judged by the Investigator to be no longer clinically significant.

  • Clinically significant abnormal laboratory findings or clinically significant abnormal findings from other assessments that are detected during the study or are present at baseline and significantly worsen following the start of the study will be reported as AEs. Abnormal laboratory findings or other assessments deemed as abnormal will not be reported as AEs if they are determined to be clinically insignificant.

  • Clinically significant discrepancies in systolic blood pressure values can be present between invasive and oscillometric non-invasive methods during hypotension [2].

  • Cytochrome enzymes: Clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.

  • Clinically significant failure to thrive, including but not limited to, weigh persistently below the 3rd %ile for age on standard growth charts or less than 85% of the ideal weight for age/and or acute weigh loss or failure to gain weight with the loss of two or more major percentiles on the growth curve.

  • Clinically significant abnormal laboratory findings or abnormal findings from other assessments that are present at baseline will be recorded as medical history.

  • Clinically significant abnormalities in laboratory values after the Screening will be recorded as AEs. NOTE: A Screening TSH level greater than 1.5 times higher than the ULN, or ALT or AST level > 2x ULN, is exclusionary; however, the patient may remain in Screening to undergo repeat liver function tests if a transient abnormality (e.g., viral illness; effects of a medication being discontinued, etc.) is thought to be responsible for their initial elevation.

  • Δ= Clinically significant difference of median keratometry measurement; which is accepted as 0.5 D[6].

  • Clinically significant changes in laboratory values, blood pressure, and pulse need not be reported as adverse events unless they prompt corrective medical action by the Investigator, constitute a serious adverse event, or lead to discontinuation of administration of study drug.


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

  • Sexually oriented business means an adult arcade, adult bookstore or adult video store, adult cabaret, adult motel, adult motion picture theater, adult theater, escort agency, nude model studio, or sexual encounter center.

  • Biologically-based mental illness means schizophrenia, schizoaffective disorder, major depressive disorder, bipolar disorder, paranoia and other psychotic disorders, obsessive-compulsive disorder, and panic disorder, as these terms are defined in the most recent edition of the diagnostic and statistical manual of mental disorders published by the American Psychiatric Association.

  • Substantially similar means substantially similar in function or capability or otherwise competitive to the products or services being developed, manufactured or sold by the Company during and/or at the end of Executive’s employment, or are marketed to substantially the same type of user or customer as that to which the products and services of the Company are marketed or proposed to be marketed.

  • Contractor Commercially Sensitive Information means the information listed in the Contractor Commercial Sensitive Information Annex to the Contract being information notified by the Contractor to the Authority which is acknowledged by the Authority as being commercially sensitive information.

  • Technically Evaluated Entity means the company which has been evaluated for the satisfaction of the technical requirement set forth in Clause 2.1.2 hereof;