Table 3.

Completeness/quality of case reports: literature versus FDA MedWatch database

Type of information	Literature case reports (n = 27) % reporting	FDA AERS cases (n = 27) % reporting	Completeness ratio	Pa
HBV statusb	100	15	6.67	<0.0001
NHL subtype	93	78	1.19	0.145
Age and gender	93	81	1.15	0.226
Prior/current immunosuppressive therapy	100	63	1.59	0.001
Number of doses of rituximab received	93	59	1.58	0.011
Time from last dose of rituximab	100	74	1.35	0.008
Liver outcome	96	52	1.85	0.001
Treatment of reactivation	89	19	4.68	0.000
Survival	96	89	1.08	0.312
Overall completeness	96 (232/242)	59 (143/242)	1.63	<0.0001

^aTwo-sided Fisher P value.

^bHBcAb(+) or HBsAg(+).

HBV, hepatitis B virus; NHL, non-Hodgkin's lymphoma; FDA, Food and Drug Administration; AERS, Adverse Event Reporting System.