Table 1 Overview of (potentially cholinergically mediated) AEs reported by younger adult subjects
MedDRA-preferred term | Placebo n=9 | 15 mg n=9 | 20 mg n=9 | 25 mg n=9 | All HTL0018318 n=27 |
|---|---|---|---|---|---|
All AEs | 5 (55.6) | 8 (88.9) | 6 (66.7) | 6 (66.7) | 20 (74.1) |
All cholinergic AEs | 1 (11.1) | 5 (55.6) | 5 (55.6) | 6 (66.7) | 16 (59.3) |
Hypertension | 0 | 0 | 0 | 0 | 0 |
Nausea | 0 | 3 (33.3) | 2 (22.2) | 4 (44.4) | 9 (33.3) |
Diarrhoea | 0 | 1 (11.1) | 1 (11.1) | 0 | 2 (7.4) |
Vomiting | 0 | 0 | 0 | 1 (11.1) | 1 (3.7) |
Hypersalivation | 0 | 0 | 0 | 1 (11.1) | 1 (3.7) |
Hyperhidrosis | 0 | 1 (11.1) | 4 (44.4) | 3 (33.3) | 8 (29.6) |
Constipation | 0 | 0 | 0 | 0 | 0 |
Chills | 0 | 1 (11.1) | 0 | 0 | 1 (3.7) |
Cold sweat | 0 | 0 | 0 | 0 | 0 |
Feeling cold | 0 | 0 | 1 (11.1) | 0 | 1 (3.7) |
Feeling hot | 0 | 0 | 1 (11.1) | 0 | 1 (3.7) |
Feeling of body temperature change | 0 | 0 | 0 | 0 | 0 |
Hot flush | 0 | 0 | 1 (11.1) | 2 (22.2) | 3 (11.1) |
Piloerection | 0 | 0 | 2 (22.2) | 0 | 2 (7.4) |
Peripheral coldness | 0 | 0 | 0 | 0 | 0 |
Insomnia | 1 (11.1) | 0 | 0 | 0 | 0 |
Dizziness | 0 | 0 | 1 (11.1) | 1 (11.1) | 2 (7.4) |
Muscle spasm | 0 | 1 (11.1) | 0 | 0 | 1 (3.7) |