Table 3.
Frequency and incidence of treatment‐emergent adverse events classified by Medra System Organ Class (SOC)
| Placebo (N = 7) | 150 M PLX‐PAD (N = 7) | 300 M PLX‐PAD (N = 6) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. event | No. subj. | % of subj. | No. event | No. subj. | % of subj. | no. event | No. subj. | % of subj. | ||
| System Organ Class | Preferred term | 42 | 6 | 85.7 | 45 | 7 | 100.0 | 28 | 6 | 100.0 |
| ‐ALL | ‐ALL | |||||||||
| Ear and labyrinth disorders | ‐ALL | 1 | 1 | 14.3 | 1 | 1 | 14.3 | 2 | 2 | 33.3 |
| Vertigo | 1 | 1 | 14.3 | 1 | 1 | 14.3 | 1 | 1 | 16.7 | |
| Vertigo positional | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Eye disorders | ‐ALL | 1 | 1 | 14.3 | 1 | 1 | 14.3 | . | . | . |
| Photophobia | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Vision blurred | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Gastrointestinal disorders | ‐ALL | 5 | 4 | 57.1 | 3 | 3 | 42.9 | 3 | 2 | 33.3 |
| Breath odour | 1 | 1 | 14.3 | 2 | 2 | 28.6 | 1 | 1 | 16.7 | |
| Constipation | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Flatulence | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Nausea | 2 | 2 | 28.6 | 1 | 1 | 14.3 | 1 | 1 | 16.7 | |
| Vomiting | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| General disorders and administration site conditions | ‐ALL | 3 | 3 | 42.9 | 2 | 2 | 28.6 | 2 | 2 | 33.3 |
| Fatigue | 1 | 1 | 14.3 | 1 | 1 | 14.3 | 1 | 1 | 16.7 | |
| Local swelling | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Pyrexia | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Pain | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Discomfort | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Immune system disorders | ‐ALL | 1 | 1 | 14.3 | . | . | . | . | . | . |
| Seasonal allergy | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Infections and infestations | ‐ALL | 1 | 1 | 14.3 | . | . | . | . | . | . |
| Gastrointestinal infection | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Injury, poisoning and procedural complications | ‐ALL | 14 | 4 | 57.1 | 18 | 7 | 100.0 | 9 | 6 | 100.0 |
| Anaemia post‐operative | 3 | 3 | 42.9 | 1 | 1 | 14.3 | . | . | . | |
| Post‐procedural haemorrhage | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Post‐procedural swelling | 4 | 2 | 28.6 | 3 | 3 | 42.9 | 4 | 3 | 50.0 | |
| Procedural hypotension | 2 | 2 | 28.6 | 3 | 2 | 28.6 | 1 | 1 | 16.7 | |
| Procedural pain | 4 | 3 | 42.9 | 7 | 5 | 71.4 | 3 | 3 | 50.0 | |
| Fall | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Muscle strain | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Suture‐related complication | . | . | . | 2 | 2 | 28.6 | . | . | . | |
| Procedural hypertension | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Musculoskeletal and connective tissue disorders | ‐ALL | 3 | 2 | 28.6 | 10 | 4 | 57.1 | 4 | 3 | 50.0 |
| Arthralgia | 1 | 1 | 14.3 | . | . | . | 2 | 1 | 16.7 | |
| Femur fracture | 1 | 1 | 14.3 | 1 | 1 | 14.3 | . | . | . | |
| Myalgia | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Extraskeletal ossification | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Humerus fracture | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Joint swelling | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Muscle spasms | . | . | . | 3 | 2 | 28.6 | 1 | 1 | 16.7 | |
| Muscle tightness | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Pain in extremity | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Sacroiliitis | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Limb asymmetry | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Nervous system disorders | ‐ALL | 4 | 4 | 57.1 | 7 | 3 | 42.9 | 1 | 1 | 16.7 |
| Dizziness postural | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Nerve compression | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Paraesthesia | 1 | 1 | 14.3 | 3 | 2 | 28.6 | . | . | . | |
| Somnolence | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Carpal tunnel syndrome | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Headache | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Hypoaesthesia | . | . | . | 1 | 1 | 14.3 | 1 | 1 | 16.7 | |
| Restless legs syndrome | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Psychiatric disorders | ‐ALL | 2 | 2 | 28.6 | 1 | 1 | 14.3 | 2 | 2 | 33.3 |
| Anxiety | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Restlessness | 1 | 1 | 14.3 | 1 | 1 | 14.3 | 1 | 1 | 16.7 | |
| Insomnia | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Renal and urinary disorders | ‐ALL | 2 | 1 | 14.3 | 1 | 1 | 14.3 | . | . | . |
| Urethral cyst | 2 | 1 | 14.3 | . | . | . | . | . | . | |
| Urinary tract infection | . | . | . | 1 | 1 | 14.3 | . | . | . | |
| Respiratory, thoracic, and mediastinal disorders | ‐ALL | 3 | 3 | 42.9 | . | . | . | 2 | 2 | 33.3 |
| Cough | 1 | 1 | 14.3 | . | . | . | . | . | . | |
| Nasopharyngitis | 2 | 2 | 28.6 | . | . | . | 2 | 2 | 33.3 | |
| Skin and subcutaneous tissue disorders | ‐ALL | 2 | 2 | 28.6 | . | . | . | 3 | 3 | 50.0 |
| Alopecia | 2 | 2 | 28.6 | . | . | . | . | . | . | |
| Erythema | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Heat rash | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Pruritus | . | . | . | . | . | . | 1 | 1 | 16.7 | |
| Reproductive system and breast disorders | ‐ALL | . | . | . | 1 | 1 | 14.3 | . | . | . |
| Breast pain | . | . | . | 1 | 1 | 14.3 | . | . | . | |