The PVOI will take care of collation, processing, assessment, reporting and followup of individual case safety report (ICSR
Of the total 4357 ICSRs from geriatric patients, 2517 (57.77%) were reported from male patients and 1803 (41.38%) from female patients.
Of the total 1120 serious ICSRs, 8 (0.71%) were found to be fatal, 582 (51.96%) with prolonged hospitalization, 61 (5.45%) with life-threatening conditions, 48 (4.29%) with disability, 398 (35.54%) with other serious conditions, and 23 (2.05%) with unknown serious ADRs.
Indian data contributed 1.73% of the geriatric ICSRs in the UMC Global database.
The new ISO Individual Case Safety Report (ICSR) standard is being finalized in 2011.
* Discussion of the upcoming ISO Individual Case Safety Report (ICSR) standard known as ICH E2B(R3)
ICSRs prepared post-marketing can differ from this in that several event terms may be reported in a single case; these events should be temporally or clinically associated and they will be ordered according to clinical relevance for the product, i.e., a serious unexpected event would be designated the 'primary event' for reporting purposes, whereas non-serious or expected events would be ranked lower within the case.
The regulations pertaining to ICSRs are both complex and precise and dictate that reports be presented in a standardized format.
(218) International Atomic Energy Agency, "International Catalogue of Sealed Radioactive Sources and Devices ICSRS