Definite Adverse Event Attribution to Product or Procedure

Definite adverse event attribution to study product or procedure is established when there is a clear-cut temporal association between product or procedure administration and adverse event, and no other possible cause is present. (NCI Thesaurus)

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Defined Substance Administration Route Of Administration Code

A coded value specifying the physiological path or method of introducing the substance into or onto the subject.

Defined Substance Administration Period Dose Total

Total of all doses of treatment in a given period of time (as defined in dosePeriodCode).

Defined Substance Administration Dose Regimen

Text description of the intended schedule for administering a substance.

Defined Substance Administration Dose Period Code

A coded value specifying the period during which the periodDoseTotal is administered.

Defined Substance Administration Dose Frequency Code

A coded value specifying how often doses are administered.

Defined Substance Administration Dose

The quantity of a substance or medication to be administered.