TABLE 6.
The incidence of serious adverse events for revefenacin.
| Serious adverse events | Events | Total | Incidence (%) |
|---|---|---|---|
| Cardiac disorders | — | — | — |
| Myocardial infarction | 6 | 2,450 | 0.24 |
| Acute myocardial infarction | 6 | 2,450 | 0.24 |
| Angina unstable | 3 | 2,450 | 0.12 |
| Coronary artery occlusion | 2 | 2,450 | 0.08 |
| Cardiac failure congestive | 2 | 2,450 | 0.08 |
| Coronary Artery Insufficiency | 1 | 2,450 | 0.04 |
| Atrial fibrillation | 1 | 2,450 | 0.04 |
| Silent myocardial infarction | 1 | 2,450 | 0.04 |
| Acute coronary syndrome | 1 | 2,450 | 0.04 |
| Cardiac arrest | 1 | 2,450 | 0.04 |
| Angina pectoris | 1 | 2,450 | 0.04 |
| Bradycardia | 1 | 2,450 | 0.04 |
| Coronary artery disease | 1 | 2,450 | 0.04 |
| Tachycardia | 1 | 2,450 | 0.04 |
| Gastrointestinal disorders | — | — | — |
| Small intestinal obstruction | 3 | 2,450 | 0.12 |
| Upper gastrointestinal hemorrhage | 3 | 2,450 | 0.12 |
| Colitis | 2 | 2,450 | 0.08 |
| Diverticulum intestinal hemorrhagic | 2 | 2,450 | 0.08 |
| Pancreatitis acute | 2 | 2,450 | 0.08 |
| Intestinal obstruction | 1 | 2,450 | 0.04 |
| Gastric volvulus | 1 | 2,450 | 0.04 |
| Abdominal pain | 1 | 2,450 | 0.04 |
| Gastrointestinal hemorrhage | 1 | 2,450 | 0.04 |
| Nausea | 1 | 2,450 | 0.04 |
| Pancreatic mass | 1 | 2,450 | 0.04 |
| Rectal hemorrhage | 1 | 2,450 | 0.04 |
| Vascular disorders | |||
| Hypertension | 1 | 2,450 | 0.04 |
| Hypotension | 1 | 2,450 | 0.04 |
| Accelerated hypertension | 1 | 2,450 | 0.04 |
| Aortic aneurysm | 1 | 2,450 | 0.04 |
| Circulatory collapse | 1 | 2,450 | 0.04 |
| Peripheral arterial occlusive disease | 1 | 2,450 | 0.04 |
| Endocrine disorders | |||
| Goitre | 1 | 2,450 | 0.04 |
| General disorders | — | — | — |
| Non-cardiac chest pain | 5 | 2,450 | 0.20 |
| Chest pain | 5 | 2,450 | 0.20 |
| Impaired healing | 1 | 2,450 | 0.04 |
| Cardiac death | 1 | 2,450 | 0.04 |
| Systemic inflammatory response syndrome | 1 | 2,450 | 0.04 |
| Hepatobiliary disorders | |||
| Jaundice | 1 | 2,450 | 0.04 |
| Infections and infestations | — | — | — |
| Pneumonia | 12 | 2,450 | 0.49 |
| Cellulitis | 4 | 2,450 | 0.16 |
| Bronchitis | 3 | 2,450 | 0.12 |
| Appendicitis | 2 | 2,450 | 0.08 |
| Bronchitis bacterial | 1 | 2,450 | 0.04 |
| Pneumonia para-influenzae viral | 1 | 2,450 | 0.04 |
| Diverticulitis | 1 | 2,450 | 0.04 |
| Pneumonia bacterial | 1 | 2,450 | 0.04 |
| Abscess neck | 1 | 2,450 | 0.04 |
| Infected skin ulcer | 1 | 2,450 | 0.04 |
| Ludwig angina | 1 | 2,450 | 0.04 |
| Osteomyelitis | 1 | 2,450 | 0.04 |
| Post procedural infection | 1 | 2,450 | 0.04 |
| Sepsis | 1 | 2,450 | 0.04 |
| Injury, poisoning and procedural complications | — | — | — |
| Femur fracture | 1 | 2,450 | 0.04 |
| Hip fracture | 1 | 2,450 | 0.04 |
| Lower limb fracture | 1 | 2,450 | 0.04 |
| Multiple fractures | 1 | 2,450 | 0.04 |
| Road traffic accident | 1 | 2,450 | 0.04 |
| Upper limb fracture | 1 | 2,450 | 0.04 |
| Musculoskeletal and connective tissue disorders | — | — | — |
| Osteoarthritis | 4 | 2,450 | 0.16 |
| Cervical spinal stenosis | 2 | 2,450 | 0.08 |
| Musculoskeletal chest pain | 2 | 2,450 | 0.08 |
| Rheumatoid arthritis | 1 | 2,450 | 0.04 |
| Muscular weakness | 1 | 2,450 | 0.04 |
| Spinal column stenosis | 1 | 2,450 | 0.04 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Lung neoplasm malignant | 2 | 2,450 | 0.08 |
| Small cell lung cancer | 2 | 2,450 | 0.08 |
| Colon cancer | 2 | 2,450 | 0.08 |
| Lung adenocarcinoma | 2 | 2,450 | 0.08 |
| Uterine leiomyoma | 1 | 2,450 | 0.04 |
| Brain cancer metastatic | 1 | 2,450 | 0.04 |
| Colon cancer stage 0 | 1 | 2,450 | 0.04 |
| Hepatic cancer | 1 | 2,450 | 0.04 |
| Lung carcinoma cell type unspecified stage IV | 1 | 2,450 | 0.04 |
| Ovarian cancer | 1 | 2,450 | 0.04 |
| Prostate cancer | 1 | 2,450 | 0.04 |
| Pancreatic carcinoma | 1 | 2,450 | 0.04 |
| Squamous cell carcinoma | 1 | 2,450 | 0.04 |
| Breast cancer | 1 | 2,450 | 0.04 |
| Nervous system disorders | — | — | — |
| Transient ischemic attack | 1 | 2,450 | 0.04 |
| Migraine | 1 | 2,450 | 0.04 |
| Carotid artery stenosis | 1 | 2,450 | 0.04 |
| Depressed level of consciousness | 1 | 2,450 | 0.04 |
| Syncope | 1 | 2,450 | 0.04 |
| Renal and urinary disorders | — | — | — |
| Renal artery stenosis | 1 | 2,450 | 0.04 |
| Reproductive system and breast disorders | — | — | — |
| Benign prostatic hyperplasia | 1 | 2,450 | 0.04 |
| Respiratory, thoracic and mediastinal disorders | — | — | — |
| Chronic obstructive pulmonary disease | 34 | 2,450 | 1.39 |
| Acute respiratory failure | 8 | 2,450 | 0.33 |
| Dyspnea | 2 | 2,450 | 0.08 |
| Pulmonary embolism | 2 | 2,450 | 0.08 |
| Respiratory failure | 2 | 2,450 | 0.08 |
| Bronchiectasis | 1 | 2,450 | 0.04 |
| Pleural effusion | 1 | 2,450 | 0.04 |
| Pulmonary granuloma | 1 | 2,450 | 0.04 |
| Pulmonary mass | 1 | 2,450 | 0.04 |
| Pneumothorax | 1 | 2,450 | 0.04 |
| Hypoxia | 1 | 2,450 | 0.04 |
| Skin and subcutaneous tissue disorders | — | — | — |
| Hyperhidrosis | 1 | 2,450 | 0.04 |
| Subcutaneous emphysema | 1 | 2,450 | 0.04 |
| Psychiatric disorders | — | — | — |
| Panic attack | 1 | 2,450 | 0.04 |
| Bipolar disorder | 1 | 2,450 | 0.04 |
| Metabolism and nutrition disorders | — | — | — |
| Lactic acidosis | 1 | 2,450 | 0.04 |