List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. (NCI)ĬDISC SDTM Category for Inclusion And Or Exclusion Terminology (NCI)Ī collection of criteria on which subjects are evaluated and that must be met by all study subjects. The period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days a specific one year period. (NCI)Īny period of seven consecutive days. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. One of the 12 divisions of a year as determined by a calendar. It is approximately 1/24 of a median day. (NCI)Ī unit measure of time equal to 3,600 seconds or 60 minutes. The time for Earth to make a complete rotation on its axis ordinarily divided into twenty-four hours. Those units of time that are routinely used to express the age of a subject. (NCI)Īn infant born prior to completion of the normal gestation period. (NCI)Īn infant during the first month after birth. (NCI)Ī person from 28 days to 23 months of age. Also describes the location of the embryo or fetus as being in the uterus in contrast to outside the uterus (ex utero). The period of time during which the embryo or fetus is present in the uterus of the female. (NCI)Īn age group comprised by people 65 years of age and older. (NCI)Ī person from 2 years to 11 years of age. (NCI)Ī person from 18 years to 65 years of age. (NCI)Ī juvenile between the onset of puberty and maturity in the state of development between puberty and maturity. One of the possible results of an adverse event outcome that indicates that the event is improving. One of the possible results of an adverse event outcome where the subject recuperated but retained pathological conditions resulting from the prior disease or injury. One of the possible results of an adverse event outcome that indicates that the event has improved or recuperated. One of the possible results of an adverse event outcome that indicates that the event has not improved or recuperated. The termination of life as a result of an adverse event. (NCI)ĬDISC SDTM Adverse Event Outcome Terminology (NCI)Ī condition or event that is attributed to the adverse event and is the result or conclusion of the adverse event. Not known, not observed, not recorded, or refused. (NCI)ĭetermination of a value is not relevant in the current context. (NCI)Īn indication that a medication schedule was modified through termination of a prescribed regimen of medication. (NCI)Īn indication that a medication schedule was modified by temporarily terminating a prescribed regimen of medication. (NCI)Īn indication that a medication schedule was modified by subtraction, either by changing the frequency, strength or amount. (NCI)Īn indication that a medication schedule was maintained. Microbiology Susceptibility Testing Result CategoryĬDISC SDTM Action Taken with Study Treatment TerminologyĪn indication that a medication schedule was modified by addition either by changing the frequency, strength or amount.
Severity/Intensity Scale for Adverse Events Common Terminology Criteria for Adverse EventsĬommon Terminology Criteria for Adverse Events V4.0
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