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Table 5 Number of treatment emergent adverse events (TEAEs) and number of subjects with TEAE by system organ class and preferred term (coded with the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.1 [45])

From: Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study

Adverse event categoryDays post treatmentGroupSeverityProbability
Cardiac disorders
 Coronary artery disease21CgMildNot related
 Myocardial infarction91UgSevereNot related
 Myocardial infarction126UgSevereNot related
Gastrointestinal disorders
 Abdominal discomfort86UgMildNot related
 Abdominal pain0UgMildPossible
 Abdominal pain0UgMildPossible
 Dental necrosis35UgModerateUnlikely
 Dysphagia242UgModerateNot related
General disorders and administration site conditions
 Chest pain149CgMildNot related
Infections and infestations
 Bronchitis231UgModerateNot related
 Diverticulitis299UgModerateNot related
 Pharyngitis133UgMildNot related
Sinusitis49UgMildNot related
 Staphylococcal infection141UgMildNot related
 Viral upper respiratory tract infection14UgMildPossible
Injury, poisoning and procedural complications
 Concussion40UgModerateNot related
 Contusion29UgMildNot related
 Ligament sprain35CgMildNot related
 Tendon rupture30CgModerateNot related
 Tooth fracture164CgModerateNot related
Musculoskeletal and connective tissue disorders
 Arthralgia (knee)8UgMildNot related
 Arthralgia (hip)114CgMildNot related
 Back pain33UgMildNot related
 Musculoskeletal pain22UgMildUnlikely
 Musculoskeletal pain43CgModeratePossible
 Musculoskeletal pain44UgMildUnlikely
 Musculoskeletal pain49CgModeratePossible
 Musculoskeletal pain64CgMildUnlikely
 Musculoskeletal pain158CgMildUnlikely
 Musculoskeletal pain168UgMildNot related
 Musculoskeletal pain224UgSevereNot related
 Pain in extremity3UgModeratePossible
 Pain in extremity120UgMildNot related
 Pain in extremity208UgMildNot related
 Progression of sPTRCT into sFTRCT114CgSevereDefinite
 Tendonitis58UgModerateNot related
 Neoplasms benign, malignant and unspecified (incl cysts and polyps)
 Seborrhoeic keratosis126UgMildNot related
Psychiatric disorders
 Alcoholism139UgMildNot related
Renal and urinary disorders
 Dysuria19UgMildNot related
Respiratory, thoracic and mediastinal disorders
 Chronic obstructive pulmonary disease296UgModerateNot related
 Cough147CgMildNot related
 Dyspnea364UgModerateNot related
 Rhinitis allergic65UgMildNot related
Skin and subcutaneous tissue disorders
 Nail discoloration126UgMildNot related
ascular disorders
 Essential hypertension129UgMildNot related
  1. Cg corticosteroid group, Ug UA-ADRCs group, sPTRCT symptomatic partial-thickness rotator cuff tear, sFTRCT symptomatic full-thickness rotator cuff tear