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Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023
Part 2DAEN — Medicines
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Part 2—DAEN – Medicines
| Column 1 | Column 2 |
|---|---|
| Item | Kinds of therapeutic goods information |
| 1 | information about an adverse event in relation to a medicine or biological that has been reported to the TGA and is recorded in the DAEN – Medicines (medicine adverse event report), as follows:(a) details of the medicine or biological;(b) details of any other therapeutic good administered to the person who is reported to have suffered the adverse event (the relevant person);(c) the age of the relevant person;(d) the sex of the relevant person;(e) the adverse event description term, as described in the MedDRA, that relates to the adverse event;(f) the date that the adverse event was recorded by the TGA;(g) the unique number allocated to the adverse event report by the TGA |
| 2 | information collated by the TGA from reports of adverse events received by the TGA in relation to a medicine or biological and recorded in the DAEN – Medicines (relevant cases), as follows:(a) the number of relevant cases;(b) the number of relevant cases where death was a reported outcome;(c) the number of relevant cases in which the medicine or biological was reported to be the only therapeutic good suspected of being related to the adverse event;(d) the system organ class terminology, as described in the MedDRA, for the part of the body that was reported as being affected by each adverse event;(e) the adverse event description term, as described in the MedDRA, that relates to each adverse event |