Table 3.
Pooled Edratide doses (N=253) | 0.5 mg Edratide (N=84) |
1 mg Edratide (N=87) |
2.5 mg Edratide (N=82) |
Placebo (N=87) | ||
---|---|---|---|---|---|---|
Preferred term | Percentage of subjects | Percentage of subjects | Percentage of subjects | Percentage of subjects | Percentage of subjects | Risk ratio of Pooled Edratide versus Placebo |
Oedema peripheral | 4.3 | 6.0 | 5.7 | 1.2 | 1.1 | 3.8 |
Liver function analyses | 3.6 | 3.6 | 3.4 | 3.7 | 1.1 | 3.3 |
Weight increased | 3.2 | 1.2 | 5.7 | 2.4 | 1.1 | 2.8 |
Hypertension (HTN)/labile HTN/blood pressure (BP) Increased/hypertensive crisis/hypertensive encephalopathy | 7.5 | 9.5 | 2.3 | 12.2 | 3.4 | 2.2 |
Fungal vaginal infection | 2.4 | 4.8 | 1.1 | 1.2 | 1.1 | 2.2 |
International normalised ratio (INR)/INR increased | 2.4 | 2.4 | 4.6 | – | 1.1 | 2.2 |
Hypoaesthesia | 2.4 | 2.4 | 3.4 | 1.2 | 1.1 | 2.1 |
Urticarias | 2.0 | 3.6 | 2.3 | – | 1.1 | 1.8 |
Back pain | 7.9 | 7.1 | 5.7 | 11.0 | 4.6 | 1.7 |
Diarrhoea | 5.9 | 3.6 | 6.9 | 7.3 | 3.4 | 1.7 |
Dizziness | 4.0 | 2.4 | 5.7 | 3.7 | 2.3 | 1.7 |
Depression | 2.0 | 1.2 | 1.1 | 3.7 | 1.1 | 1.7 |
Dyspnoea | 2.0 | 1.2 | 3.4 | 1.2 | 1.1 | 1.7 |
Palpitations | 2.0 | 2.4 | 2.3 | 1.2 | 1.1 | 1.7 |
Nausea and vomiting symptoms | 11.9 | 14.3 | 9.2 | 12.2 | 8.0 | 1.5 |
Injection site reactions | 17.8 | 17.9 | 16.1 | 19.5 | 12.6 | 1.4 |
Insomnia | 3.2 | 4.8 | 2.3 | 2.4 | 2.3 | 1.4 |
Seasonal allergy | 1.6 | 1.2 | – | 3.7 | 1.1 | 1.4 |
Arthralgia/musculoskeletal pain | 5.9 | 8.4 | 4.6 | 4.9 | 4.6 | 1.3 |
Cough | 4.3 | 3.6 | 6.9 | 2.4 | 4.6 | 0.9 |
Dermatitis and eczema | 2.0 | – | 1.1 | 4.9 | 2.3 | 0.9 |
Herpes viral infections | 4.3 | 2.4 | 8.0 | 2.4 | 0 | 0 |
Vertigo/vertigo positional | 4.0 | 4.8 | 4.6 | 2.4 | 0 | 0 |
Migraine | 3.2 | 1.2 | 6.9 | 1.2 | 0 | 0 |
Tachycardia/tachycardia paroxysmal | 3.2 | 3.6 | 4.6 | 1.2 | 0 | 0 |
Pharyngitis | 2.4 | 3.6 | 1.1 | 2.4 | 0 | 0 |
Sciatica | 2.0 | 1.2 | 3.4 | 1.2 | −0 | 0 |
Dysgeusia | 2.0 | 0 | – | 6.1 | 0 | 0 |
Abdominal pain upper | 2.0 | 0 | 3.4 | 2.4 | 0 | 0 |