Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice

Table 1 Number of cases and rate of PDSS in routine clinical practice

Parameter	Post-marketing safety studies		Post-marketing safety studies combined	Spontaneous reports	Overall ^a
Parameter	Global observational study (B034)	US Patient Care Program Registry (B041)	Post-marketing safety studies combined	Spontaneous reports	Overall ^a
Total number of injections	38,721	49,991	88,712	411,209^b	499,921^c
Total number of patients	2131	4001	6132	58,868^d	65,000^d
Number of PDSS events	19 (in 18 patients)	47 (in 45 patients)	66 (in 63 patients)	272 (in 270 patients)	338
Rate of PDSS (% of injections)	0.05	0.09	0.07	0.07^e	N/A^f
Rate of PDSS (% of patients)	0.84	1.1	1.03	0.46^g	N/A^f

^aPost-marketing safety studies and spontaneous reports combined.
^bEstimated by excluding the number of vials used in the post-marketing safety studies, and assuming that only 75% of all vials sold are used.
^cIncludes estimated number of injections administered outside of the post-marketing safety studies.
^dEstimated number of patients receiving an injection outside of the post-marketing safety studies.
^eBased on the estimated number of injections administered outside of the post-marketing safety studies.
^f Not applicable; actual rates from post-marketing safety studies and estimated rates from spontaneous reports cannot be combined.
^gBased on the estimated number of patients receiving an injection outside of the post-marketing safety studies.
PDSS = post-injection delirium/sedation syndrome.

ISSN: 1471-244X