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Table 4 Summary of the overall treatment-mergent adverse events by the treatment group for parent study ALZ2002 and extension study ALZ2004 (safety analysis set)

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

Safety analysis setTreatment group at start ALZ2002Treatment group in ALZ2004
Double-blind parentDouble-blind periodOpen-label period
Placebo10 mg50 mgTotalPlacebo10 mg25 mgTotalAtabecestat
PBO→5 mgPBO→25 mg10 mg → 5 mg25 mgTotal
N393738114352926901514262277
Total patients with TEAEs,n(%)27 (69.2)23 (62.6)31 (81.6)81 (71.1)22 (62.9)15 (51.7)21 (80.8)58 (64.4)10 (66.7)11 (78.6)19 (73.1)16 (72.7)56 (72.7)
Serious TEAEs,n(%)4 (10.3)2 (5.4)8 (21.1)14 (12.3)3 (8.6)4 (13.8)4 (15.4)11 (12.2)2 (13.3)4 (28.6)0 (0)1 (4.5)7 (9.1)
TEAEs leading to death,n(%)0 (0)1 (2.7)0 (0)1 (0.9)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
Any AE leading to discontinuation or withdrawal (%)1 (2.6)2 (5.4)5 (13.2)8 (7.0)0 (0)2 (6.9)1 (3.8)3 (3.3)2 (13.3)2 (14.3)0 (0)0 (0)4 (5.2)
  1. TEAE treatment-emergent adverse events, coded using MedDRA version 21.0
  2. Adverse events (AEs) with onset on or after the first dose of study drug in ALZ2004 through the last dose in period 1 are included. For a participant who withdrew during period 1, adverse events through the day of the last dose plus 7 days are included
  3. AEs with onset on or after the first dose of study drug in period 2 of ALZ2004 through the day of the last dose in period 2 plus 7 days are included