Table 4. Incidence of adverse events by treatment group and total in randomized double-blind, placebo-controlled study.
| System Organ Class | P60.4Ac | Placebo | Total |
|---|---|---|---|
| Preferred Term | n (%) | n (%) | n (%) |
| Cardiac disorders | 1 (6%) | 0 (0%) | 1 (3%) |
| Arrhythmia | 1 (6%)a | 0 (0%) | 1 (3%) |
| Ear and labyrinth disorders | 1 (6%) | 4 (25%) | 5 (15%) |
| Ear canal stenosis | 0 (0%) | 1 (6%)b | 1 (3%) |
| Otolgia (ear pain) | 1 (6%) | 2 (13%) | 3 (9%) |
| Tinitis | 0 (0%) | 1 (6%) | 1 (3%) |
| Eye disorders | 1 (6%) | 1 (6%) | 2 (6%) |
| Conjunctivitis | 0 (0%) | 1 (6%) | 1 (3%) |
| Eye inflammation | 1 (6%) | 0 (0%) | 1 (3%) |
| Gastrointestinal disorders | 0 (0%) | 1 (6%) | 1 (3%) |
| Food poisoning | 1 (6%) | 1 (6%)a | 1 (3%) |
| Infections and infestations | 8 (47%) | 3 (19%) | 11 (33%) |
| Bronchitis viral | 1 (6%) | 0 (0%) | 1 (3%) |
| Erysipelas | 0 (0%) | 1 (6%) | 1 (3%) |
| Gastroenteritis viral | 1 (6%) | 0 (0%) | 1 (3%) |
| Nasopharyngitis | 1 (6%) | 0 (0%) | 1 (3%) |
| Otitis externa | 2 (12%) | 0 (0%) | 2 (6%) |
| Otitis media | 2 (12%)b | 1 (6%)b | 3 (9%) |
| Otitis media acute | 0 (0%) | 1 (6%)b | 1 (3%) |
| Sinusitis | 1 (6%) | 0 (0%) | 1 (3%) |
| Investigations | 2 (12%) | 2 (13%) | 4 (12%) |
| Biopsy | 1 (6%) | 0 (0%) | 1 (3%) |
| Blood bilirubin increased | 0 (0%) | 1 (6%) | 1 (3%) |
| Red blood cell sedimentation rate increased | 1 (6%) | 1 (6%) | 2 (6%) |
| Nervous system disorders | 2 (12%) | 3 (19%) | 5 (15%) |
| Convulsion | 0 (0%) | 1 (6%) | 1 (3%) |
| Headache | 2 (12%) | 1 (6%)b | 3 (9%) |
| Transient ischaemic attack | 0 (0%) | 1 (6%)a | 1 (6%) |
| Respiratory disorders | 2 (12%) | 0 (0%) | 2 (6%) |
| Dyspnoea | 1 (6%) | 0 (0%) | 1 (3%) |
| Pharyngolaryngeal pain | 1 (6%) | 0 (0%) | 1 (3%) |
| Skin and subcutaneous disorders | 0 (0%) | 2 (13%) | 2 (6%) |
| Erythema | 0 (0%) | 1 (6%) | 1 (3%) |
| Excessive granulation tissue | 0 (0%) | 1 (6%) | 1 (3%) |
| Total | 17 | 16 | 33 |
| Any subject with AE | 10 (59%) | 13 (81%) | 23 (70%) |
a Event reported as serious adverse event (SAE)
b Event reported as treatment-related event
Totals per system organ class are presented in bold