TABLE 5.
The incidence of non-serious adverse events for revefenacin.
| Non-serious adverse events | Events | Total | Incidence (%) |
|---|---|---|---|
| Infections and infestations | — | — | — |
| Nasopharyngitis | 83 | 2,450 | 3.39 |
| Upper respiratory tract infection | 75 | 2,450 | 3.06 |
| Bronchitis | 34 | 2,450 | 1.39 |
| Urinary tract infection | 31 | 2,450 | 1.27 |
| Sinusitis | 31 | 2,450 | 1.27 |
| Tooth infection | 1 | 2,450 | 0.04 |
| Viral infection | 1 | 2,450 | 0.04 |
| Acute sinusitis | 1 | 2,450 | 0.04 |
| Ear Infection | 1 | 2,450 | 0.04 |
| Furuncle | 1 | 2,450 | 0.04 |
| Investigations | — | — | — |
| Electrocardiogram T wave peaked | 3 | 2,450 | 0.12 |
| Metabolism and nutrition disorders | — | — | — |
| Gout | 2 | 2,450 | 0.08 |
| Nervous system disorders | — | — | — |
| Headache | 103 | 2,450 | 4.20 |
| Dizziness | 1 | 2,450 | 0.04 |
| Tremor | 1 | 2,450 | 0.04 |
| Respiratory, thoracic and mediastinal disorders | — | — | — |
| Chronic obstructive pulmonary disease exacerbation | 273 | 2,450 | 11.14 |
| Cough | 95 | 2,450 | 3.88 |
| Dyspnea | 90 | 2,450 | 3.67 |
| Pneumonia | 21 | 2,450 | 0.86 |
| Dysphonia | 1 | 2,450 | 0.04 |
| Chest Discomfort | 2 | 2,450 | 0.08 |
| Rhinorrhea | 3 | 2,450 | 0.12 |
| Oropharyngeal pain | 6 | 2,450 | 0.24 |
| Rhonchi | 1 | 2,450 | 0.04 |
| Sputum increased | 1 | 2,450 | 0.04 |
| Gastrointestinal disorders | — | — | — |
| Diarrhea | 27 | 2,450 | 1.10 |
| Gastroesophageal reflux disease | 16 | 2,450 | 0.65 |
| Nausea | 16 | 2,450 | 0.65 |
| Dry mouth | 3 | 2,450 | 0.12 |
| Oral discomfort | 1 | 2,450 | 0.04 |
| Inguinal hernia | 1 | 2,450 | 0.04 |
| Vomiting | 1 | 2,450 | 0.04 |
| General disorders | — | 2,450 | — |
| Fatigue | 4 | 2,450 | 0.16 |
| Oedema | 2 | 2,450 | 0.08 |
| Injury, poisoning and procedural complications | — | — | — |
| Contusion | 6 | 2,450 | 0.24 |
| Muscle contusion | 1 | 2,450 | 0.04 |
| Eye swelling | 1 | 2,450 | 0.04 |
| Eye contusion | 1 | 2,450 | 0.04 |
| Procedural pain | 1 | 2,450 | 0.04 |
| Musculoskeletal and connective tissue disorders | — | — | — |
| Back pain | 37 | 2,450 | 1.51 |
| Arthralgia | 15 | 2,450 | 0.61 |
| Pain in extremity | 1 | 2,450 | 0.04 |
| Muscle spasms | 1 | 2,450 | 0.04 |
| Musculoskeletal pain | 1 | 2,450 | 0.04 |
| Neck pain | 1 | 2,450 | 0.04 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Basal cell carcinoma | 1 | 2,450 | 0.04 |
| Skin and subcutaneous tissue disorders | — | 2,450 | — |
| Rash | 6 | 2,450 | 0.24 |
| Dermatitis contact | 2 | 2,450 | 0.08 |
| Skin lesion | 1 | 2,450 | 0.04 |
| Vascular disorders | 2,450 | ||
| Hypertension | 27 | 2,450 | 1.10 |
| Hematoma | 2 | 2,450 | 0.08 |
| Blood pressure increased | 1 | 2,450 | 0.04 |
| Hypotension | 1 | 2,450 | 0.04 |
| Coronary artery insufficiency | 1 | 2,450 | 0.04 |
| Psychiatric disorders | — | — | — |
| Insomnia | 1 | 2,450 | 0.04 |