Table 5 Incidence of the most frequent (> 5%) adverse events occurring in the ALZ2002 and the ALZ2004 double-blind and open-label periods
Body system/preferred term | Treatment group | ||||
|---|---|---|---|---|---|
ALZ2002 (double-blind) | Placebo | Ata 10 mg | Ata 50 mg | Total | |
N | 39 | 37 | 38 | 114 | |
Diarrhea | 2 (5.1%) | 3 (8.1%) | 7 (18.4%) | 12 (10.5%) | |
Nasopharyngitis | 5 (12.8%) | 3 (8.1%) | 3 (7.9%) | 11 (9.6%) | |
Headache | 4 (10.3%) | 2 (5.4%) | 2 (5.3%) | 8 (7.0%) | |
Back pain | 2 (5.1%) | 2 (5.4%) | 2 (5.3%) | 6 (5.3%) | |
Hypertension | 3 (7.7%) | 2 (5.4%) | 1 (2.6%) | 6 (5.3%) | |
Transaminases increased | 0 | 2 (5.4%) | 3 (7.9%) | 5 (4.4%) | |
Urinary tract infection | 4 (10.3%) | 1 (2.7%) | 0 | 5 (4.4%) | |
Influenza | 1 (2.6%) | 0 | 2 (5.3%) | 3 (2.6%) | |
Syncope | 3 (7.7%) | 0 | 0 | 3 (2.6%) | |
Vomiting | 3 (7.7%) | 0 | 0 | 2 (2.6%) | |
Cataract | 2 (5.1%) | 0 | 0 | 2 (1.8%) | |
Gastroesophageal reflux disease | 0 | 0 | 2 (5.3%) | 2 (1.8%) | |
Alanine aminotransferase increased | 0 | 2 (5.4%) | 3 (7.9%) | 5 (4.4%) | |
Vitamin B12decreased | 2 (5.1%) | 0 | 0 | 2 (1.8%) | |
ALZ2004, double-blind period | Placebo | Ata 10 mg | Ata 25 mg | Total | |
N | 35 | 29 | 26 | 90 | |
Cataract | 6 (17.1%) | 0 | 2 (7.7%) | 8 (8.9%) | |
Nasopharyngitis | 2 (5.7%) | 2 (6.9%) | 2 (7.7%) | 6 (6.7%) | |
Bronchitis | 1 (2.9%) | 1 (3.4%) | 3 (11.5%) | 5 (5.6%) | |
Fall | 2 (5.7%) | 2 (6.9%) | 0 | 4 (4.4%) | |
Diarrhea | 1 (2.9%) | 1 (3.4%) | 1 (3.8%) | 3 (3.3%) | |
Depressive symptom | 0 | 2 (6.9%) | 0 | 2 (2.2%) | |
Insomnia | 0 | 0 | 2 (7.7%) | 2 (2.2) | |
Malaise | 0 | 2 (6.9%) | 0 | 2 (2.2%) | |
ALZ2004 open-label period | Placebo/Ata 5 mg | Placebo/Ata 25 mg | Ata 5 mg | Ata 25 mg | Total |
N | 15 | 14 | 28 | 22 | 77 |
Nasopharyngitis | 1 (6.7%) | 3 (21.4%) | 3 (11.5%) | 1 (4.5%) | 8 (10.4%) |
Headache | 0 | 2 (14.3%) | 3 (11.5%) | 1 (4.5%) | 6 (7.8%) |
Back pain | 1 (6.7%) | 0 | 0 | 3 (13.6%) | 4 (5.2%) |
Pneumonia | 0 | 2 (14.3%) | 2 (7.7%) | 0 | 4 (5.2%) |
Cataract | 0 | 0 | 2 (7.7%) | 1 (4.5%) | 3 (3.9%) |
Macular fibrosis | 0 | 0 | 0 | 2 (9.1%) | 2 (2.6%) |
Depression | 2 (13.3%) | 0 | 0 | 1 (4.5%) | 3 (3.9%) |
Nightmare | 2 (13.3%) | 1 (7.1%) | 0 | 0 | 3 (3.9%) |
Insomnia | 0 | 0 | 0 | 2 (9.1%) | 2 (2.6%) |
Confusional state | 0 | 1 (7.1%) | 0 | 0 | 1 (1.3%) |
Delirium | 1 (6.7%) | 0 | 0 | 0 | 1 (1.3%) |
Psychotic disorder | 0 | 1 (7.1%) | 0 | 0 | 1 (1.3%) |