Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination [Erratum]

Figures & data

Table 3 ADRs of TBD vs Reported by Individual Active Ingredient

SOC	PT	TBD	B	p	T	p	D	p
Eye disorders	Eye irritation	30.9%	9%	<0.0001^c***^a	12%	<0.0001^c***^a	32%	0.7709^c
	Eye pruritus	1.2%	20%	<0.0001^d***^b	5%	0.0183^d*^b	1%	>0.9999^d
	Vision blurred	2%	4%	0.1898^c	5%	0.0840^c	5%	0.0840^c
	Ocular hyperemia	0.4%	20%	<0.0001^d***^b	5%	0.0020^d**^b	5%	0.0020^d**^b
	Eye pain	0.4%	4%	0.0061^d**^b	5%	0.0020^d**^b	-	-
Gastrointestinal disorders	Dry mouth	0.4%	9%	<0.0001^d***^b	5%	0.0020^d**^b	-	-
Nervous system disorders	Dysgeusia	0.8%	4%	0.0194^d*^b	-	-	25%	<0.0001^d***^b
	Headache	0.4%	4%	0.0061^d**^b	5%	0.0020^d**^b	-	-
	Somnolence	0.4%	4%	0.0061^d**^b	-	-	5%	0.0020^d**^b
Investigations	Blood pressure decreased	0.4%	4%	0.0061^d**^b	1%	0.3153^d	-	-
Infections and infestations	Nasopharyngitis	0.8%	-	-	-	-	-	-

Notes: Significance, *p<0.05, **p<0.01, ***p<0.001. ^aThe statistical significance is above expected to TBD. ^bThe statistical significance is below expected to TBD. ^cPearson Chi-square test. ^dFisher’s exact test.

Abbreviations: SOC, System Organ Class; PT, preferred term; TBD, timolol/brimonidine/dorzolamide fixed combination; T, timolol; B, brimonidine; D, dorzolamide.