Table 4:
Adverse events between month 12 and 24 in the extension study by system organ class, preferred term, and treatment group.
| Treatment | |||||
|---|---|---|---|---|---|
| Active 22 people | Placebo 21 people | ||||
| System Organ Class | Preferred Term | N | Per 100 people | N | Per 100 people |
| Total | 19 | 86.4 | 11 | 52.4 | |
| EAR AND LABYRINTH DISORDERS | VERTIGO | 1 | 4.5 | -- | -- |
| EYE DISORDERS | CONJUNCTIVAL HAEMORRHAGE | 1 | 4.5 | -- | -- |
| CONJUNCTIVAL IRRITATION | -- | -- | 1 | 4.8 | |
| PHOTOPHOBIA | -- | -- | 1 | 4.8 | |
| PHOTOPSIA | 1 | 4.5 | -- | -- | |
| GASTROINTESTINAL DISORDERS | DYSPEPSIA | 1 | 4.5 | -- | -- |
| HEPATOBILIARY DISORDERS | HEPATOMEGALY | 1 | 4.5 | -- | -- |
| INFECTIONS AND INFESTATIONS | BRONCHITIS | 1 | 4.5 | -- | -- |
| GINGIVAL INFECTION | -- | -- | 1 | 4.8 | |
| INFECTION | 1 | 4.5 | -- | -- | |
| LUNG INFECTION | 1 | 4.5 | -- | -- | |
| NASAL ABSCESS | 1 | 4.5 | -- | -- | |
| NASOPHARYNGITIS | 1 | 4.5 | -- | -- | |
| TOOTH INFECTION | 1 | 4.5 | -- | -- | |
| URINARY TRACT INFECTION | 1 | 4.5 | -- | -- | |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | ARTHROPOD BITE | 1 | 4.5 | -- | -- |
| EPICONDYLITIS | -- | -- | 1 | 4.8 | |
| FRACTURE | 1 | 4.5 | -- | -- | |
| INVESTIGATIONS | BLOOD CALCIUM INCREASED | 1 | 4.5 | -- | -- |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | BACK PAIN | 1 | 4.5 | 1 | 4.8 |
| NECK PAIN | -- | -- | 1 | 4.8 | |
| TRIGGER FINGER | 1 | 4.5 | -- | -- | |
| NERVOUS SYSTEM DISORDERS | DIZZINESS | -- | -- | 1 | 4.8 |
| SCIATICA | -- | -- | 1 | 4.8 | |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | ALLERGIC COUGH | 1 | 4.5 | -- | -- |
| COUGH | 1 | 4.5 | -- | -- | |
| SURGICAL AND MEDICAL PROCEDURES | CATARACT OPERATION | -- | -- | 2 | 9.5 |
| VASCULAR DISORDERS | BLOOD PRESSURE FLUCTUATION | -- | -- | 1 | 4.8 |