Table 3

Edratide common adverse events (AEs)—incidence presented by preferred/high-level term and dose and sorted by the risk ratio of pooled Edratide doses versus placebo

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 termPercentage of subjectsPercentage of subjectsPercentage of subjectsPercentage of subjectsPercentage of subjectsRisk ratio of Pooled Edratide versus Placebo
Oedema peripheral4.36.05.71.21.13.8
Liver function analyses3.63.63.43.71.13.3
Weight increased3.21.25.72.41.12.8
Hypertension (HTN)/labile HTN/blood pressure (BP) Increased/hypertensive crisis/hypertensive encephalopathy7.59.52.312.23.42.2
Fungal vaginal infection2.44.81.11.21.12.2
International normalised ratio (INR)/INR increased2.42.44.61.12.2
Hypoaesthesia2.42.43.41.21.12.1
Urticarias2.03.62.31.11.8
Back pain7.97.15.711.04.61.7
Diarrhoea5.93.66.97.33.41.7
Dizziness4.02.45.73.72.31.7
Depression2.01.21.13.71.11.7
Dyspnoea2.01.23.41.21.11.7
Palpitations2.02.42.31.21.11.7
Nausea and vomiting symptoms11.914.39.212.28.01.5
Injection site reactions17.817.916.119.512.61.4
Insomnia3.24.82.32.42.31.4
Seasonal allergy1.61.23.71.11.4
Arthralgia/musculoskeletal pain5.98.44.64.94.61.3
Cough4.33.66.92.44.60.9
Dermatitis and eczema2.01.14.92.30.9
Herpes viral infections4.32.48.02.400
Vertigo/vertigo positional4.04.84.62.400
Migraine3.21.26.91.200
Tachycardia/tachycardia paroxysmal3.23.64.61.200
Pharyngitis2.43.61.12.400
Sciatica2.01.23.41.2−00
Dysgeusia2.006.100
Abdominal pain upper2.003.42.400