Examples of Medically significant in a sentence
Medically significant dental disease or dental neglect, with signs and/or symptoms of local or systemic infection that would likely require a dental procedure during the course of the study.
Medically significant serious adverse events considered related to the investigational product by the investigator will be reported through the web portal ToetsingOnline to the accredited METC that approved the protocol within 7 days of first knowledge.
Medically significant dental disease or dental neglect with signs and or symptoms of local or systemic infection that would likely require a dental procedure during the course of the study.
Medically significant and likely tobe significantly affecting activities of daily living.Grade 4An adverse event that requires urgent intervention or may have life-threateningconsequences.Grade 5Death related to the adverse event.
Medically significant and likely tobe significantly affecting activities of daily living.Grade 4An adverse event that requires urgentintervention or may have life-threatening consequences.Grade 5Death related to the adverse event.
Medically significant infections are increased in patients with juvenile idiopathic arthritis treated with etanercept: results from the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study.
Medically significant changes in vital signs and ECGs will be reviewed, as available.
Medically significant malnutrition, defined as moderate malnutrition (wt-for-ht z-score between -3.0 and -2.0) and severe malnutrition (wt-for-ht z-score <-3.0 or edema) Continued Eligibility CriteriaFulfilment of all of the following continuing eligibility criteria is required for all participants to receive their second vaccination (Day 14).
Medically significant AEs reported from Day 30 to 6 months after the last vaccination(s) and SAEs reported during the course of the study (between Visit 1 through the 6-month follow-up after the 12- month vaccination(s)) did not reveal safety concerns.
Medically significant amendments to the protocol (e.g., changes that increase the risk or the inconveniences for the subject, inclusion of new categories of subjects, etc.) must be approved by the local IRB or other relevant ethic committee prior to implementation.