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. 2015 Aug 11;2(1):e000104. doi: 10.1136/lupus-2015-000104

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 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