<status value="draft"/> <experimental value="false"/> <date value="2020-04-09T21:10:28+00:00"/> <publisher value="HL7 (FHIR Project)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> <telecom> <system value="email"/> <value value="fhir@lists.hl7.org"/> </telecom> </contact> <description value="Codes for the assessment of whether the entity caused the event."/> <caseSensitive value="true"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-causality-assess"/> <content value="complete"/> <concept> <code value="certain"/> <display value="Certain"/> <definition value="i) Event or laboratory test abnormality, with plausible time relationship to drug intake; ii) Cannot be explained by disease or other drugs; iii) Response to withdrawal plausible (pharmacologically, pathologically); iv) Event definitive pharmacologically or phenomenologically (i.e. an objective and specific medical disorder or a recognized pharmacological phenomenon); or v) Re-challenge satisfactory, if necessary."/> </concept> <concept> <code value="probably-likely"/> <display value="Probably/Likely"/> <definition value="i) Event or laboratory test abnormality, with reasonable time relationship to drug intake; ii) Unlikely to be attributed to disease or other drugs; iii) Response to withdrawal clinically reasonable; or iv) Re-challenge not required."/> </concept> <concept> <code value="possible"/> <display value="Possible"/> <definition value="i) Event or laboratory test abnormality, with reasonable time relationship to drug intake; ii) Could also be explained by disease or other drugs; or iii) Information on drug withdrawal may be lacking or unclear."/> </concept> <concept> <code value="unlikely"/> <display value="Unlikely"/> <definition value="i) Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable (but not impossible); or ii) Disease or other drugs provide plausible explanations."/> </concept> <concept> <code value="conditional-classified"/> <display value="Conditional/Classified"/> <definition value="i) Event or laboratory test abnormality; ii) More data for proper assessment needed; or iii) Additional data under examination."/> </concept> <concept> <code value="unassessable-unclassifiable"/> <display value="Unassessable/Unclassifiable"/> <definition value="i) Report suggesting an adverse reaction; ii) Cannot be judged because information is insufficient or contradictory; or iii) Data cannot be supplemented or verified."/> </concept> </CodeSystem>

This code system http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess defines the following codes:

Code	Display	Definition
certain	Certain	i) Event or laboratory test abnormality, with plausible time relationship to drug intake; ii) Cannot be explained by disease or other drugs; iii) Response to withdrawal plausible (pharmacologically, pathologically); iv) Event definitive pharmacologically or phenomenologically (i.e. an objective and specific medical disorder or a recognized pharmacological phenomenon); or v) Re-challenge satisfactory, if necessary.
probably-likely	Probably/Likely	i) Event or laboratory test abnormality, with reasonable time relationship to drug intake; ii) Unlikely to be attributed to disease or other drugs; iii) Response to withdrawal clinically reasonable; or iv) Re-challenge not required.
possible	Possible	i) Event or laboratory test abnormality, with reasonable time relationship to drug intake; ii) Could also be explained by disease or other drugs; or iii) Information on drug withdrawal may be lacking or unclear.
unlikely	Unlikely	i) Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable (but not impossible); or ii) Disease or other drugs provide plausible explanations.
conditional-classified	Conditional/Classified	i) Event or laboratory test abnormality; ii) More data for proper assessment needed; or iii) Additional data under examination.
unassessable-unclassifiable	Unassessable/Unclassifiable	i) Report suggesting an adverse reaction; ii) Cannot be judged because information is insufficient or contradictory; or iii) Data cannot be supplemented or verified.