Table 3. Adverse Events and Serious Adverse Events.

Event	Vitamin E (n = 152)	Memantine (n = 155)	Vitamin E + Memantine (n = 154)	Placebo (n = 152)
Adverse events
Patients with event, No. (%)	91 (60)	97 (63)	90 (58)	89 (59)
Adverse event, No. of events	198	196	211	202
Event attributed to study medications, No. of eventsa	35	29	33	24
Adverse event >5% and ≥placebo, No. of events (% of patients with event)b
Falls	58 (20)	38 (17)	64 (23)	48 (20)
Bleedingc	6 (4)	5 (3)	11 (6)	5 (3)
Serious adverse events
Patients with event, No. (%)	82 (54)	84 (54)	83 (54)	95 (63)
Serious adverse event, No. of events	180	187	179	170
Event attributed to study medications, No. of eventsa	19	18	13	19
Type of event, No. of eventsd
Hospitalization	152	143	146	128
Other	14	20	41	28
Death	26	39	32	31
Annual mortality rate, %e	7.3	11.3	9.0	9.4
Cause of deathf
Cardiac disorders	5	10	8	10
Nervous system disorders	4	6	6	5
Infections or infestations	4	4	3	2
Neoplasms	4	5	3	1
Respiratory disorders	2	4	5	3
Other	5	6	6	8
Unknown	2	4	1	2
Serious adverse event >5% and ≥placebo, No. of events (% of patients with an event)b
Falls	16 (10)	16 (10)	14 (8)	18 (10)
Bleedingc	7 (5)	10 (5)	7 (5)	10 (5)
Pneumonia	11 (5)	9 (5)	15 (10)	5 (3)
Urinary tract infection	8 (5)	8 (5)	13 (5)	5 (3)
All infections or infestationsg	29 (13)	31 (15)	44 (20)	13 (7)

^aThe principal investigator at each clinical site determined whether an adverse event or serious adverse event was attributed to study therapy.

^bAdverse events and serious adverse events are listed according to the preferred term used in the Medical Dictionary for Regulatory Activities (MedDRA).

^cBleeding events are calculated by combining preferred terms from MedDRA and other events that involved bleeding.

^dMore than 1 event type permitted for serious adverse events.

^eCox proportional hazard ratio for vitamin E relative to placebo = 0.87; 95% CI, 0.67-1.13; P = .31.

^fCause of death is based on the organ class system used in MedDRA.

^gInfections or infestations are based on the organ class system used in MedDRA; ${\mathrm{\chi }}_3^2$ test of a difference across treatment groups P = .01; ${\mathrm{\chi }}_1^2$ test for vitamin E vs placebo P = .12, for memantine vs placebo P = .03, and for vitamin E + memantine vs placebo P = .001.