TABLE VII.
Adverse Events in the Safety Population (N = 124) Coded According to MedDRA Terminology*
| System Organ Class or Preferred Term | Autologous Iliac Bone-Graft Group† | CBVF Group† | Total† | |||
| Patients (N = 62) | Patients with Adverse Events (N = 58) | Patients (N = 62) | Patients with Adverse Events (N = 52) | Patients (N = 124) | Patients with Adverse Events (N = 110) | |
| Subjects with any adverse event | 32 (51.6%) | 58 (100.0%) | 28 (45.2%) | 52 (100.0%) | 60 (48.4%) | 110 (100.0%) |
| Gastrointestinal disorders | 8 (12.9%) | 11 (19.0%) | 4 (6.5%) | 6 (11.5%) | 12 (9.7%) | 17 (15.5%) |
| Constipation | 4 (6.5%) | 4 (6.9%) | 1 (1.6%) | 1 (1.9%) | 5 (4.0%) | 5 (4.5%) |
| Flatulence | 1 (1.6%) | 1 (1.7%) | 2 (3.2%) | 2 (3.8%) | 3 (2.4%) | 3 (2.7%) |
| Lip blister | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Nausea | 4 (6.4%) | 4 (6.9%) | 2 (3.2%) | 3 (5.8%) | 6 (4.8%) | 7 (6.4%) |
| Vomiting | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Injury, poisoning, and procedural complications | 7 (11.3%) | 8 (13.8%) | 8 (12.9%) | 8 (15.4%) | 15 (12.1%) | 16 (14.5%) |
| Bone comminution | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Fall | 2 (3.2%) | 2 (3.4%) | 1 (1.6%) | 1 (1.9%) | 3 (2.4%) | 3 (2.7%) |
| Fracture displacement | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Fracture nonunion | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Joint dislocation | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Postprocedural hematoma | 1 (1.6%) | 1 (1.7%) | 1 (1.6%) | 1 (1.9%) | 2 (1.6%) | 2 (1.8%) |
| Procedural complication | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Procedural nausea | 1 (1.6%) | 1 (1.7%) | 1 (1.6%) | 1 (1.9%) | 2 (1.6%) | 2 (1.8%) |
| Procedural vomiting | 1 (1.6%) | 1 (1.7%) | 1 (1.6%) | 1 (1.9%) | 2 (1.6%) | 2 (1.8%) |
| Seroma | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Prolonged wound-healing | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Musculoskeletal and connective tissue disorders | 7 (11.3%) | 7 (12.1%) | 6 (9.7%) | 9 (17.3%) | 13 (10.5%) | 16 (14.5%) |
| Arthralgia | 1 (1.6%) | 1 (1.7%) | 1 (1.6%) | 2 (3.8%) | 2 (1.6%) | 3 (2.7%) |
| Arthrofibrosis | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Compartment syndrome | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Joint swelling | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Musculoskeletal pain | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Musculoskeletal stiffness | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Osteoarthritis | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Osteopenia | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Pain in extremity | 4 (6.4%) | 4 (6.9%) | 0 (0.0%) | 0 (0.0%) | 4 (3.2%) | 4 (3.6%) |
| Synovitis | 0 (0.0%) | 0 (0.0%) | 2 (3.2%) | 2 (3.8%) | 2 (1.6%) | 2 (1.8%) |
| General disorders and administration site conditions | 5 (8.1%) | 6 (10.3%) | 6 (9.7%) | 7 (13.5%) | 11 (8.9%) | 13 (11.8%) |
| Catheter site pain | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Feeling abnormal | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Impaired healing | 1 (1.6%) | 1 (1.7%) | 2 (3.2%) | 2 (3.8%) | 3 (2.4%) | 3 (2.7%) |
| Implant site inflammation | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Edema | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Pyrexia | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Secretion discharge | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Swelling | 3 (4.8%) | 3 (5.2%) | 0 (0.0%) | 0 (0.0%) | 3 (2.4%) | 3 (2.7%) |
| Tenderness | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Infections and infestations | 5 (8.1%) | 6 (10.3%) | 3 (4.8%) | 3 (5.7%) | 8 (6.5%) | 9 (8.2%) |
| Diverticulitis | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Gastrointestinal infection | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Infected bite | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Nasopharyngitis | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Upper respiratory tract infection | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Urinary tract infection | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Wound infection | 1 (1.6%) | 2 (3.4%) | 1 (1.6%) | 1 (1.9%) | 2 (1.6%) | 3 (2.7%) |
| Nervous system disorders | 3 (4.8%) | 3 (5.2%) | 6 (9.7%) | 6 (11.5%) | 9 (7.3%) | 9 (8.2%) |
| Dizziness | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Dysesthesia | 1 (1.6%) | 1 (1.7%) | 1 (1.6%) | 1 (1.9%) | 2 (1.6%) | 2 (1.8%) |
| Ischemic cerebral infarction | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Paresthesia | 2 (3.2%) | 2 (3.4%) | 1 (1.6%) | 1 (1.9%) | 3 (2.4%) | 3 (2.7%) |
| Sensory disturbance | 0 (0.0%) | 0 (0.0%) | 2 (3.2%) | 2 (3.8%) | 2 (1.6%) | 2 (1.8%) |
| Psychiatric disorders | 5 (8.1%) | 5 (8.6%) | 3 (4.8%) | 3 (5.7%) | 8 (6.5%) | 8 (7.3%) |
| Depression | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Insomnia | 1 (1.6%) | 1 (1.7%) | 2 (3.2%) | 2 (3.8%) | 3 (2.4%) | 3 (2.7%) |
| Sleep disorder | 3 (4.8%) | 3 (5.2%) | 1 (1.6%) | 1 (1.9%) | 4 (3.2%) | 4 (3.6%) |
| Vascular disorders | 3 (4.8%) | 3 (5.2%) | 3 (4.8%) | 4 (7.7%) | 6 (4.8%) | 7 (6.4%) |
| Circulatory collapse | 2 (3.2%) | 2 (3.4%) | 0 (0.0%) | 0 (0.0%) | 2 (1.6%) | 2 (1.8%) |
| Deep vein thrombosis | 1 (1.6%) | 1 (1.7%) | 2 (3.2%) | 2 (3.8%) | 3 (2.4%) | 3 (2.7%) |
| Hypertension | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Peripheral artery aneurysm | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Skin and subcutaneous tissue disorders | 2 (3.2%) | 2 (3.4%) | 2 (3.2%) | 2 (3.8%) | 4 (3.2%) | 4 (3.6%) |
| Erythema | 1 (1.6%) | 1 (1.7%) | 1 (1.6%) | 1 (1.9%) | 2 (1.6%) | 2 (1.8%) |
| Rash | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Skin warmth | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Neoplasms: benign, malignant, and unspecified (including cysts and polyps) | 2 (3.2%) | 2 (3.4%) | 1 (1.6%) | 1 (1.9%) | 3 (2.4%) | 3 (2.7%) |
| Basal cell carcinoma | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Invasive ductal breast carcinoma | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Laryngeal cancer | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Metabolism and nutrition disorders | 2 (3.2%) | 2 (3.4%) | 0 (0.0%) | 0 (0.0%) | 2 (1.6%) | 2 (1.8%) |
| Hypokalemia | 2 (3.2%) | 2 (3.4%) | 0 (0.0%) | 0 (0.0%) | 2 (1.6%) | 2 (1.8%) |
| Blood and lymphatic system disorders | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Hemorrhagic anemia | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Cardiac disorders | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Cardiovascular disorder | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Immune system disorders | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Drug hypersensitivity | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Investigations | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Body temperature increased | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Respiratory, thoracic, and mediastinal disorders | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Oropharyngeal pain | 0 (0.0%) | 0 (0.0%) | 1 (1.6%) | 1 (1.9%) | 1 (0.8%) | 1 (0.9%) |
| Surgical and medical procedures | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
| Open reduction of fracture | 1 (1.6%) | 1 (1.7%) | 0 (0.0%) | 0 (0.0%) | 1 (0.8%) | 1 (0.9%) |
*
MedDRA® the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). MedDRA® trademark is registered by IFPMA (the International Federation of Pharmaceutical Manufacturers & Associations) on behalf of ICH. With use of MedDRA terminology, clinical signs and symptoms associated with possible complications of the surgical intervention were assessed at every study visit. All other adverse events were reported freely and were documented using a standard adverse event form together with intensity, relationship to study treatment, required actions, and outcome. Laboratory tests and vital signs were not included in the standard case report form. However, if they were considered abnormal by the treating surgeon, they had to be documented as an adverse event.
†
The values are given as the number of patients, with the percentage in parentheses.