Table 2.
Treatment-emergent adverse events
| MedDRA preferred term | Placebo (n = 6) |
Praliciguat 40 mg | ||
|---|---|---|---|---|
| Twice daily / once dailya (n = 10) |
Once daily / once dailyb (n = 10) |
Overall (n = 20) |
||
| Any TEAE | 5 (83) | 6 (60) | 8 (80) | 14 (70) |
| Headache | 2 (33) | 2 (20) | 3 (30) | 5 (25) |
| Hypoglycaemia | 2 (33) | 2 (20) | 3 (30) | 5 (25) |
| Nausea | 0 | 2 (20) | 3 (30) | 5 (25) |
| Diarrhoea | 1 (17) | 0 | 3 (30) | 3 (15) |
| Abdominal pain | 0 | 0 | 2 (20) | 2 (10) |
| Dyspepsia | 0 | 1 (10) | 1 (10) | 2 (10) |
| Injection site haemorrhage | 3 (50) | 0 | 1 (10) | 1 (5) |
| Cough | 0 | 0 | 1 (10) | 1 (5) |
| Dry throat | 0 | 0 | 1 (10) | 1 (5) |
| Oropharyngeal pain | 0 | 0 | 1 (10) | 1 (5) |
| Alopecia | 0 | 0 | 1 (10) | 1 (5) |
| Gastrointestinal sounds abnormal | 0 | 0 | 1 (10) | 1 (5) |
| Costochondritis | 0 | 0 | 1 (10) | 1 (5) |
| Paronychia | 0 | 0 | 1 (10) | 1 (5) |
| Dizziness | 1 (17) | 1 (10) | 0 | 1 (5) |
| Anaemia | 0 | 1 (10) | 0 | 1 (5) |
| Eye irritation | 0 | 1 (10) | 0 | 1 (5) |
| Dry mouth | 0 | 1 (10) | 0 | 1 (5) |
| Eructation | 0 | 1 (10) | 0 | 1 (5) |
| Gastroesophageal reflux disease | 0 | 1 (10) | 0 | 1 (5) |
| Oesophagitis | 0 | 1 (10) | 0 | 1 (5) |
| Upper gastrointestinal haemorrhage | 0 | 1 (10) | 0 | 1 (5) |
| Vomiting | 0 | 1 (10) | 0 | 1 (5) |
| Muscle spasms | 0 | 1 (10) | 0 | 1 (5) |
| Pain in extremity | 0 | 1 (10) | 0 | 1 (5) |
| Injection site injury | 0 | 1 (10) | 0 | 1 (5) |
| Dermatitis contact | 0 | 1 (10) | 0 | 1 (5) |
| Pseudohypoglycaemia | 1 (17) | 0 | 0 | 0 |
| Limb discomfort | 1 (17) | 0 | 0 | 0 |
| Tremor | 1 (17) | 0 | 0 | 0 |
| Nephrolithiasis | 1 (17) | 0 | 0 | 0 |
| Nocturia | 1 (17) | 0 | 0 | 0 |
Data are presented as n (%)
a20 mg twice daily for 7 days, then 40 mg once daily for 7 days
b40 mg once daily for 14 days
MedDRA, Medical Dictionary for Regulatory Activities