Details about each adverse reaction event linked to exposure to the identified 'Substance'
Identification of the specific substance considered to be responsible for the adverse reaction event. For example: 'Amoxycillin '.
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Certainty
integer
Clinical symptoms and/or signs that are observed or associated with the adverse reaction
text
Narrative description about the adverse reaction as a whole, including details of the manifestation if required
text
Record of the date and/or time of the onset of the reaction
datetime
The total amount of time that the manifestation of the adverse reaction persisted
durationDatetime
Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations
integer
Additional details about the adverse reaction, including anatomical location and Common Toxicity Criteria
text
Record of the date and/or time of the first exposure to the Substance for this Reaction Event
datetime
The total amount of time the individual was exposed to the identified 'Specific substance'
durationDatetime
Identification of the route by which the subject was exposed to the identified 'Specific substance'.
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Narrative description about exposure to the identified 'Specific substance'
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Additional details about exposure to the 'Specific substance', especially in Situations where there may have been multiple or cumulative exposures can be provided
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Narrative description about the clinical management provided
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Additional structured details about clinical management for this reaction event can be provided
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Additional structured details required for reporting to regulatory bodies can be provided
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Details about the provenance of the information can be provided
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Additional narrative about the adverse reaction event not captured in other fields
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