Table 6.
Breakdown of adverse events (SAS).
| MedDRA version 24.0 | |||
|---|---|---|---|
| System organ class (SOC), Preferred term (PT) | (N = 23) |
||
| n | (%) | Number of events | |
| Any adverse event | 20 | (86.96) | 46 |
| Infections and infestations | 16 | (69.57) | 26 |
| Upper respiratory tract infection | 10 | (43.48) | 13 |
| Nasopharyngitis | 4 | (17.39) | 7 |
| Gastroenteritis | 2 | (8.70) | 2 |
| Bronchitis | 1 | (4.35) | 1 |
| Otitis media acute | 1 | (4.35) | 1 |
| Pneumonia bacterial | 1 | (4.35) | 1 |
| Sinusitis | 1 | (4.35) | 1 |
| Skin and subcutaneous tissue disorders | 9 | (39.13) | 11 |
| Eczema infantile | 4 | (17.39) | 4 |
| Eczema | 3 | (13.04) | 4 |
| Dermatitis diaper | 2 | (8.70) | 2 |
| Eczema asteatotic | 1 | (4.35) | 1 |
| Gastrointestinal disorders | 3 | (13.04) | 4 |
| Diarrhoea | 2 | (8.70) | 2 |
| Gastroesophageal reflux disease | 1 | (4.35) | 1 |
| Vomiting | 1 | (4.35) | 1 |
| Respiratory, thoracic and mediastinal disorders | 2 | (8.70) | 2 |
| Rhinitis allergic | 1 | (4.35) | 1 |
| Chronic respiratory failure | 1 | (4.35) | 1 |
| General disorders and administration site conditions | 1 | (4.35) | 1 |
| Pyrexia | 1 | (4.35) | 1 |
| Injury, poisoning and procedural complications | 1 | (4.35) | 1 |
| Thermal burn | 1 | (4.35) | 1 |
| Nervous system disorders | 1 | (4.35) | 1 |
| Seizure | 1 | (4.35) | 1 |
SAS, safety analysis set; MedDRA, medical dictionary for regulatory activities.