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. Author manuscript; available in PMC: 2014 Jul 24.
Published in final edited form as: JAMA. 2014 Jan 1;311(1):33–44. doi: 10.1001/jama.2013.282834

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)
a

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

b

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

c

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

d

More than 1 event type permitted for serious adverse events.

e

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

f

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

g

Infections or infestations are based on the organ class system used in MedDRA; χ32 test of a difference across treatment groups P = .01; χ12 test for vitamin E vs placebo P = .12, for memantine vs placebo P = .03, and for vitamin E + memantine vs placebo P = .001.