Table 3.
Other symptoms/events reported captured as free-text events and presented as MedDRA® preferred term (% of total other events reported)
| System organ class (SOC) | PT | n (%) |
|---|---|---|
| Infections and infestations | Nasopharyngitis | 2 (5.7) |
| Tonsillitis | 1 (2.9) | |
| Urinary tract infection | 1 (2.9) | |
| Hordeolum | 1 (2.9) | |
| Influenza | 1 (2.9) | |
| Psychiatric disorders | Mood altered | 1 (2.9) |
| Nervous system disorders | Dizziness | 1 (2.9) |
| Lethargy | 1 (2.9) | |
| Migraine | 1 (2.9) | |
| Ear and labyrinth disorders | Cerumen impaction | 1 (2.9) |
| Ear pain | 1 (2.9) | |
| Gastrointestinal disorders | Diarrhoea | 4 (11.4) |
| Mouth ulceration | 2 (5.7) | |
| Abdominal pain upper | 1 (2.9) | |
| Anal inflammation | 1 (2.9) | |
| Chapped lips | 1 (2.9) | |
| Dysphagia | 1 (2.9) | |
| Skin and subcutaneous tissue disorders | Pruritus | 1 (2.9) |
| Blister | 1 (2.9) | |
| Musculoskeletal and connective tissue disorders | Growing pains | 1 (2.9) |
| Reproductive system and breast disorders | Vulvovaginal rash | 1 (2.9) |
| General disorders and administration site conditions | Fatigue | 7 (20.0) |
| Irritability | 1 (2.9) | |
| Adverse drug reaction | 1 (2.9) | |
| Total | 35 (100.0) |
PT preferred term