Summary of treatment emergent adverse events occurring in two or more participants in OHS and participants with T2DM
| Number of events | |||||
|---|---|---|---|---|---|
| OHS | T2DM | ||||
| System organ class | Adverse event | Placebo (n=24) | SRT2104 (n=24) | Placebo (n=14) | SRT2104 n=15) |
| Any event | 18 | 18 | 11 | 14 | |
| Nervous system disorders | Any event | 6 (25%) | 11 (46%) | 1 (7%) | 7 (47%) |
| Headache | 4 | 6 | 1 | 5 | |
| Paraesthesia | 0 | 2 | 0 | 1 | |
| Hypoaesthesia | 1 | 2 | 0 | 0 | |
| Presyncope | 1 | 1 | 0 | 0 | |
| Respiratory, thoracic and mediastinal disorders | Any event | 1 (4%) | 3 (13%) | 0 | 3 (20%) |
| Oropharyngeal pain | 1 | 2 | 0 | 0 | |
| Rhinorrhoea | 0 | 1 | 0 | 1 | |
| Gastrointestinal disorders | Any event | 3 (13%) | 1 (4%) | 4 (29%) | 8 (53%) |
| Diarrhoea | 0 | 0 | 2 | 4 | |
| Nausea | 0 | 0 | 1 | 2 | |
| Abdominal pain upper | 1 | 0 | 0 | 1 | |
| Dyspepsia | 0 | 0 | 0 | 2 | |
| Reproductive system and breast disorders | Any event | 3 (13%) | 1 (4%) | 0 | 0 |
| Dysmenorrhea | 3 | 1 | 0 | 0 | |
| Musculoskeletal and connective tissue disorders | Any event | 4 (17%) | 1 (4%) | 0 | 2 (13%) |
| Back pain | 2 | 0 | 0 | 0 | |
| Investigational | Any event | 2 (8%) | 1 (4%) | 1 (7%) | 1 (7) |
| Blood bilirubin increased | 1 | 1 | 0 | 0 | |
| Alanine amino transferase increased | 0 | 0 | 1 | 0 | |
| Abnormal liver function test | 0 | 0 | 0 | 1 | |
| General disorders and administration site conditions | Any event | 4 (17%) | 4 (17%) | 2 (14%) | 3 (20%) |
| Influenza like illness | 1 | 0 | 0 | 1 | |
| Fatigue | 1 | 0 | 1 | 1 | |
| Infections and infestations | Any event | 3 (13%) | 5 (21%) | 3 (21%) | 1 (7%) |
| Nasopharyngitis | 0 | 1 | 3 | 0 | |
| Rhinitis | 2 | 2 | 0 | 0 | |
| Upper respiratory tract infection | 1 | 0 | 0 | 1 | |
| Injury, poisoning and procedural complications | Any event | 4 (17%) | 2 (8%) | 3 (21%) | 1 (7%) |
| Contusion | 1 | 0 | 1 | 0 | |
| Excoriation | 1 | 1 | 0 | 0 | |
| Skin and subcutaneous tissue | Any event | 1 (4%) | 0 | 1 (7%) | 3 (20%) |
| Pruritus | 0 | 0 | 0 | 2 | |
| Metabolism and nutrition disorders | Any event | 0 | 1 (4%) | 2 (14%) | 2 (13%) |
| Hypoglycaemia | 0 | 0 | 1 | 2 | |
| Vascular disorders | Any event | 0 | 1 (4%) | 0 | 2 (13%) |
| Flushing | 0 | 0 | 0 | 2 | |
OHS, otherwise healthy cigarette smokers; T2DM, type 2 diabetes mellitus.