Table 2 Overview of (potentially cholinergically mediated) AEs reported by elderly subjects
MedDRA-preferred term | Placebo n=14 | 15 mg n=9 | 20 mg n=9 | 25 mg n=9 | 35 mg n=2 | 35 mg + up-titration n=7 | All HTL0018318 n=36 |
|---|---|---|---|---|---|---|---|
All AEs | 8 (57.1) | 7 (77.8) | 7 (77.8) | 9 (100.0) | 2 (100.0) | 7 (100.0) | 32 (88.9) |
All cholinergic AEs | 2 (14.3) | 1 (11.1) | 5 (55.6) | 7 (77.8) | 2 (100) | 7 (100) | 22 (61.1) |
Hypertension | 0 | 0 | 0 | 1 | 1 | 1 | 3 (8.3) |
Nausea | 0 | 1 (11.1) | 1 (11.1) | 2 (22.2) | 0 | 0 | 4 (11.1) |
Diarrhoea | 0 | 0 | 0 | 1 (11.1) | 0 | 0 | 1 (2.8) |
Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Constipation | 1 (7.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Hypersalivation | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hyperhidrosis | 0 | 0 | 3 (33.3) | 5 (55.6) | 0 | 2 (28.6) | 10 (27.8) |
Chills | 0 | 0 | 0 | 1 (11.1) | 0 | 4 (57.1) | 5 (13.9) |
Cold sweat | 0 | 0 | 0 | 0 | 1 (50.0) | 2 (28.6) | 3 (8.3) |
Feeling cold | 1 (7.1) | 0 | 1 (11.1) | 2 (22.2) | 1 (50.0) | 2 (28.6) | 6 (16.7) |
Feeling hot | 0 | 0 | 0 | 2 (22.2) | 0 | 0 | 2 (5.6) |
Feeling of body temperature change | 0 | 0 | 0 | 1 (11.1) | 0 | 0 | 1 (2.8) |
Hot flush | 0 | 0 | 2 (22.2) | 1 (11.1) | 0 | 2 (28.6) | 5 (13.9) |
Peripheral coldness | 0 | 0 | 0 | 0 | 1 (50.0) | 0 | 1 (2.8) |
Piloerection | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Insomnia | 0 | 0 | 1 | 0 | 0 | 0 | 1 (2.8) |
Dizziness | 1 | 0 | 0 | 3 | 0 | 0 | 3 (8.3) |
Muscle spasm | 0 | 0 | 1 | 0 | 0 | 0 | 1 (2.8) |