Incidence of adverse events by disease or event category
| Disorders | Adverse events [number of events (number of participants)] | |
|---|---|---|
| Etanercept (n = 7) | Placebo (n = 6) | |
| All disorders | 38 events | 67 events |
| Blood and lymphatic disorders [bruising of arm, bruising (2)] | 0 (0) | 3 (1) |
| Cardiac disorders (chest tightness, bundle branch block right) | 0 (0) | 2 (1) |
| Congenital, familial, and genetic disorders | 0 (0) | 0 (0) |
| Ear and labyrinth disorders | 0 (0) | 0 (0) |
| Endocrine disorders | 0 (0) | 0 (0) |
| Eye disorders (retinal tear, vision disorder) | 2 (2) | 0 (0) |
| Gastrointestinal disorders (dyspepsia, diarrhoea, constipation) | 6 (4) | 1 (1) |
| General disorders and administration site injections [pain (3), hay fever (2), feeling cold, blister, injection site discomfort, injection site bruising, giddiness, haematoma] | 5 (3) | 10 (4) |
| Hepatobiliary disorders (hypertension) | 1 (1) | 0 (0) |
| Immune system disorders | 0 (0) | 0 (0) |
| Infections and infestations [cellulitis, skin bacterial infection (2)] | 2 (2) | 1 (1) |
| Injury, poisoning, and procedural complications [falls (5), skin abrasion, corneal abrasion, vitreous detachment, injury, tooth fracture] | 4 (3) | 6 (4) |
| Investigations (itching, irregular pulse, irritable mood) | 1 (1) | 2 (2) |
| Metabolism and nutrition disorders (mouth ulcer, muscle pain) | 0 (0) | 2 (1) |
| Musculoskeletal and connective tissue disorders [neck pain, back pain (4), musculoskeletal stiffness] | 1(1) | 6 (3) |
| Neoplasms, benign, and malignant [squamous cell carcinoma (2)] | 2 (2) | 0 (0) |
| Nervous system disorders [insomnia (2), headache (3), migraine, diplopia, numbness localised, dizziness (2), anxiety, transient cerebrovascular event] | 5 (4) | 7 (5) |
| Pregnancy, puerperium, and perinatal conditions | 0 (0) | 0 (0) |
| Psychiatric disorders [Alzheimer’s dementia (2), low mood, Raynaud’s disease] | 2 (2) | 2 (2) |
| Renal and urinary disorders [urinary tract infection (5), nocturia] | 1 (1) | 5 (3) |
| Reproductive system and breast disorders | 0 (0) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders [viral upper respiratory tract infection (6), upper respiratory tract infection (2), lower respiratory tract infection, coughing, and associated symptoms (3), shortness of breath)] | 3 (1) | 10 (5) |
| Skin and s.c. tissue disorders [herpes simplex (2), rash papular, rash erythematous, acne, dry skin, skin tear] | 2 (2) | 5 (3) |
| Social circumstances | 0 (0) | 0 (0) |
| Surgical and medical procedures (eye laser surgery, carpal tunnel syndrome surgery, tooth pain, tooth extraction, toe surgery) | 1 (1) | 5 (3) |
| Vascular disorders | 0 (0) | 0 (0) |
Adverse events include definitely, probably, possibly, unlikely, and not thought to be related to the study intervention. Participants could report multiple events in any category. Adverse drug reactions are coded by the Medical Dictionary for Regulatory Activities (MedDRA) preferred term (MedDRA 15.0)
