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])
Adverse event category | Days post treatment | Group | Severity | Probability |
|---|---|---|---|---|
Cardiac disorders | ||||
 Coronary artery disease | 21 | Cg | Mild | Not related |
 Myocardial infarction | 91 | Ug | Severe | Not related |
 Myocardial infarction | 126 | Ug | Severe | Not related |
Gastrointestinal disorders | ||||
 Abdominal discomfort | 86 | Ug | Mild | Not related |
 Abdominal pain | 0 | Ug | Mild | Possible |
 Abdominal pain | 0 | Ug | Mild | Possible |
 Dental necrosis | 35 | Ug | Moderate | Unlikely |
 Dysphagia | 242 | Ug | Moderate | Not related |
General disorders and administration site conditions | ||||
 Chest pain | 149 | Cg | Mild | Not related |
Infections and infestations | ||||
 Bronchitis | 231 | Ug | Moderate | Not related |
 Diverticulitis | 299 | Ug | Moderate | Not related |
 Pharyngitis | 4 | Cg | Mild | Unlikely |
 Pharyngitis | 133 | Ug | Mild | Not related |
Sinusitis | 49 | Ug | Mild | Not related |
 Staphylococcal infection | 141 | Ug | Mild | Not related |
 Viral upper respiratory tract infection | 14 | Ug | Mild | Possible |
Injury, poisoning and procedural complications | ||||
 Concussion | 40 | Ug | Moderate | Not related |
 Contusion | 29 | Ug | Mild | Not related |
 Ligament sprain | 35 | Cg | Mild | Not related |
 Tendon rupture | 30 | Cg | Moderate | Not related |
 Tooth fracture | 164 | Cg | Moderate | Not related |
Musculoskeletal and connective tissue disorders | ||||
 Arthralgia (knee) | 8 | Ug | Mild | Not related |
 Arthralgia (hip) | 114 | Cg | Mild | Not related |
 Back pain | 33 | Ug | Mild | Not related |
 Musculoskeletal pain | 22 | Ug | Mild | Unlikely |
 Musculoskeletal pain | 43 | Cg | Moderate | Possible |
 Musculoskeletal pain | 44 | Ug | Mild | Unlikely |
 Musculoskeletal pain | 49 | Cg | Moderate | Possible |
 Musculoskeletal pain | 64 | Cg | Mild | Unlikely |
 Musculoskeletal pain | 158 | Cg | Mild | Unlikely |
 Musculoskeletal pain | 168 | Ug | Mild | Not related |
 Musculoskeletal pain | 224 | Ug | Severe | Not related |
 Pain in extremity | 3 | Ug | Moderate | Possible |
 Pain in extremity | 120 | Ug | Mild | Not related |
 Pain in extremity | 208 | Ug | Mild | Not related |
 Progression of sPTRCT into sFTRCT | 114 | Cg | Severe | Definite |
 Tendonitis | 58 | Ug | Moderate | Not related |
 Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
 Seborrhoeic keratosis | 126 | Ug | Mild | Not related |
Psychiatric disorders | ||||
 Alcoholism | 139 | Ug | Mild | Not related |
Renal and urinary disorders | ||||
 Dysuria | 19 | Ug | Mild | Not related |
Respiratory, thoracic and mediastinal disorders | ||||
 Chronic obstructive pulmonary disease | 296 | Ug | Moderate | Not related |
 Cough | 147 | Cg | Mild | Not related |
 Dyspnea | 27 | Ug | Moderate | Unlikely |
 Dyspnea | 364 | Ug | Moderate | Not related |
 Rhinitis allergic | 65 | Ug | Mild | Not related |
Skin and subcutaneous tissue disorders | ||||
 Nail discoloration | 126 | Ug | Mild | Not related |
ascular disorders | ||||
 Essential hypertension | 129 | Ug | Mild | Not related |