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Table 3 Summary of reported AEs from the pooled analysis

From: Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer’s disease

n (%) BI 409306
10 mg QD
(n = 77)
BI 409306
25 mg QD
(n = 74)
BI 409306
50 mg QD
(n = 76)
BI 409306
25 mg BID
(n = 76)
Placebo
(n = 149)
Patients with any AE 34 (44.2) 30 (40.5) 45 (59.2) 37 (48.7) 67 (45.0)
Patients with severe AEs* 2 (2.6) 1 (1.4) 1 (1.3) 1 (1.3) 1 (0.7)
Patients with investigator-defined, drug-related AEs 5 (6.5) 5 (6.8) 15 (19.7) 8 (10.5) 12 (8.1)
Patients with AEs leading to discontinuation of trial drug 1 (1.3) 1 (1.4) 2 (2.6) 1 (1.3) 5 (3.4)
Patients with AEs of special interest 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Patients with SAEs 1 (1.3) 3 (4.1) 1 (1.3) 4 (5.3) 9 (6.0)
 Resulted in death 1 (1.3) 0 (0) 0 (0) 0 (0) 0 (0)
 Was life-threatening 0 (0) 0 (0) 1 (1.3) 0 (0) 0 (0)
 Persisted or caused significant disability/incapacity 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Required, or prolonged, hospitalisation 1 (1.3) 2 (2.7) 0 (0) 4 (5.3) 7 (4.7)
 Congenital anomaly or birth defect 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Other medically important serious event 0 (0) 1 (1.4) 0 (0) 1 (1.3) 2 (1.3)
Patients with other significant AEs (according to ICH E3) 0 (0) 0 (0) 1 (1.3) 0 (0) 4 (2.7)
  1. *There was one subject with AEs leading to death (BI 409306 10 mg group). AE adverse event, BID twice daily, ICH E3 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline E3, QD once daily, SAE serious adverse event