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