Table 4. Summary of Adverse Events (AEs).
| Placebo (N=47) |
LD (N=48) |
SD (N=46) |
HD (N=45) |
BZN (N=45) |
|
|---|---|---|---|---|---|
| Any Treatment Emergent Adverse Events (TEAEs) | 38 (8·9%) [95] | 37 (77·1%) [116] | 40 (87..%) [116] | 33 (73·3%) [131] | 39 (86·7%) [165] |
| Any TEAEs judged ‘related’ to treatment | 14 (29·8%) [17] | 15 (31·3%) [28] | 24 (52·2%) [39] | 20 (44·4%) [48] | 29 (64·4%) [89] |
| Any TEAEs resulting in treatment discontinuation | 0 (0·0%) [0] | 0 (0·0%) [0] | 0 (0·0%) [0] | 5 (11·1%) [8] a | 4 (8·9%) [6] b |
| Any Treatment Emergent Serious Adverse Events (SAEs) | 0 (0·0%) [0] | 0 (0·0%) [0] | 1 (2·2%) [1] | 3 (6·7%) [3] | 2 (4·4%) [2] |
| Any Treatment Emergent SAEs judged ‘related’ to treatment | 0 (0·0%) [0] | 0 (0·0%) [0] | 0 (0·0%) [0] | 2 (4·4%) [2] | 0 (0·0%) [0] |
| Any Deaths | 0 (0·0%) [0] | 0 (0·0%) [0] | 0 (0·0%) [0] | 0 (0·0%) [0] | 0 (0·0%) [0] |
Presented: number of patients (percent of patients) [number of events]
a
TEAEs leading to drug discontinuation: one with infective cholecystitis that showed also increased ALT, AST and GGT). Two patients presented increased ALT and two patients presented increased AST.
b
TEAEs leading to drug discontinuation: four with hypersensitivity, and one among them with ALT increased