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. 2011 Mar 8;7(1):102–111. doi: 10.5114/aoms.2011.20612

Table IV.

Most common adverse events (> 5%) and serious adverse events (> 1%) in any treatment group, all causalities, safety population

Preferred term (PT) Placebo BID (N= 353) n(%) 100 mg BID (N= 352) n(%) 150 mg BID (N= 347) n(%)
Adverse events
 Fall 51 (14.4) 58 (16.5) 45 (13.0)
 Depression 43 (12.2) 29 (8.2) 33 (9.5)
 Nausea 42 (11.9) 58 (16.5) 75 (21.6)
 Diarrhoea 41 (11.6) 41 (11.6) 49 (14.1)
 Dizziness 39 (11.0) 50 (14.2) 38 (11.0)
 Urinary tract infection 39 (11.0) 38 (10.8) 32 (9.2)
 Upper respiratory tract infection 34 (9.6) 27 (7.7) 32 (9.2)
 Agitation 31 (8.8) 34 (9.7) 26 (7.5)
 Headache 29 (8.2) 25 (7.1) 28 (8.1)
 Vomiting 28 (7.9) 33 (9.4) 47 (13.5)
 Fatigue 25 (7.1) 26 (7.4) 23 (6.6)
 Back Pain 25 (7.1) 23 (6.5) 23 (6.6)
 Weight decrease 24 (6.8) 38 (10.8) 52 (15.0)
 Insomnia 23 (6.5) 18 (5.1) 16 (4.6)
 Cough 22 (6.2) 16 (4.5) 16 (4.6)
 Nasopharyngitis 21 (5.9) 22 (6.3) 18 (5.2)
 Anxiety 20 (5.7) 21 (6.0) 17 (4.9)
 Syncope fainting 13 (3.7) 19 (5.4) 25 (7.2)
Serious adverse events
 Syncope 9 (2.5) 10 (2.9) 13 (3.8)
 Congestive cardiac failure 7 (2.0) 4 (1.1) 1 (0.3)
 Fall 4 (1.1) 5 (1.4) 1 (0.3)
 Myocardial infarction 4 (1.1) 2 (0.6) 0 (0.0)
 Pneumonia 2 (0.6) 4 (1.1) 8 (2.3)

MedDRA (Version 9.0) was used. PT presented in decreasing order of incidence in the placebo group. Patients are counted once per PT using the most severe level for that event. For some PT, incidence may be derived from more than one System Organ Class

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