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Table 5 Incidence of the most frequent (> 5%) adverse events occurring in the ALZ2002 and the ALZ2004 double-blind and open-label periods

From: Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer’s disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study

Body system/preferred termTreatment group
ALZ2002 (double-blind)PlaceboAta 10 mgAta 50 mgTotal
N393738114
Diarrhea2 (5.1%)3 (8.1%)7 (18.4%)12 (10.5%)
Nasopharyngitis5 (12.8%)3 (8.1%)3 (7.9%)11 (9.6%)
Headache4 (10.3%)2 (5.4%)2 (5.3%)8 (7.0%)
Back pain2 (5.1%)2 (5.4%)2 (5.3%)6 (5.3%)
Hypertension3 (7.7%)2 (5.4%)1 (2.6%)6 (5.3%)
Transaminases increased02 (5.4%)3 (7.9%)5 (4.4%)
Urinary tract infection4 (10.3%)1 (2.7%)05 (4.4%)
Influenza1 (2.6%)02 (5.3%)3 (2.6%)
Syncope3 (7.7%)003 (2.6%)
Vomiting3 (7.7%)002 (2.6%)
Cataract2 (5.1%)002 (1.8%)
Gastroesophageal reflux disease002 (5.3%)2 (1.8%)
Alanine aminotransferase increased02 (5.4%)3 (7.9%)5 (4.4%)
Vitamin B12decreased2 (5.1%)002 (1.8%)
ALZ2004, double-blind periodPlaceboAta 10 mgAta 25 mgTotal
N35292690
Cataract6 (17.1%)02 (7.7%)8 (8.9%)
Nasopharyngitis2 (5.7%)2 (6.9%)2 (7.7%)6 (6.7%)
Bronchitis1 (2.9%)1 (3.4%)3 (11.5%)5 (5.6%)
Fall2 (5.7%)2 (6.9%)04 (4.4%)
Diarrhea1 (2.9%)1 (3.4%)1 (3.8%)3 (3.3%)
Depressive symptom02 (6.9%)02 (2.2%)
Insomnia002 (7.7%)2 (2.2)
Malaise02 (6.9%)02 (2.2%)
ALZ2004 open-label periodPlacebo/Ata 5 mgPlacebo/Ata 25 mgAta 5 mgAta 25 mgTotal
N1514282277
Nasopharyngitis1 (6.7%)3 (21.4%)3 (11.5%)1 (4.5%)8 (10.4%)
Headache02 (14.3%)3 (11.5%)1 (4.5%)6 (7.8%)
Back pain1 (6.7%)003 (13.6%)4 (5.2%)
Pneumonia02 (14.3%)2 (7.7%)04 (5.2%)
Cataract002 (7.7%)1 (4.5%)3 (3.9%)
Macular fibrosis0002 (9.1%)2 (2.6%)
Depression2 (13.3%)001 (4.5%)3 (3.9%)
Nightmare2 (13.3%)1 (7.1%)003 (3.9%)
Insomnia0002 (9.1%)2 (2.6%)
Confusional state01 (7.1%)001 (1.3%)
Delirium1 (6.7%)0001 (1.3%)
Psychotic disorder01 (7.1%)001 (1.3%)