Table 3.
Adverse events by age group
| Children (n = 230) | Adolescents (n = 138) | Adults (n = 433) | ||||
|---|---|---|---|---|---|---|
| Patients, n (%) | Events, n | Patients, n (%) | Events, n | Patients, n (%) | Events, n | |
| Total | 13 (5.7) | 15 | 5 (3.6)a | 6 | 36 (8.3) | 47 |
| Gastrointestinal disorders | 10 (4.3) | 10 | 4 (2.9) | 5 | 30 (6.9) | 36 |
| Oral pruritus | 4 (1.7) | 4 | 3 (2.2) | 3 | 15 (3.5) | 15 |
| Pruritus of tongue | 0 | 0 | 1 (0.7) | 1 | 7 (1.6) | 7 |
| Abdominal pain | 4 (1.7) | 4 | 0 | 0 | 1 (0.2) | 1 |
| Glossodynia | 2 (0.9) | 2 | 1 (0.7) | 1 | 1 (0.2) | 1 |
| Upper abdominal pain | 0 | 0 | 0 | 0 | 3 (0.7) | 3 |
| Swollen tongue | 0 | 0 | 0 | 0 | 2 (0.5) | 2 |
| Pruritus of the lips | 0 | 0 | 0 | 0 | 2 (0.5) | 2 |
| Gastrointestinal disorder | 0 | 0 | 0 | 0 | 2 (0.5) | 2 |
| Diarrhoea | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Gastroesophageal reflux disease | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Gastric reflux | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Skin and skin structure disorders | 2 (0.9) | 2 | 1 (0.7) | 1 | 5 (1.2) | 5 |
| Angioedema | 0 | 0 | 0 | 0 | 3 (0.7) | 3 |
| Pruritus | 1 (0.4) | 1 | 1 (0.7) | 1 | 1 (0.2) | 1 |
| Urticaria | 1 (0.4) | 1 | 0 | 0 | 1 (0.2) | 1 |
| Nervous system disorders | 1 (0.4) | 1 | 0 | 0 | 1 (0.2) | 1 |
| Headache | 1 (0.4) | 1 | 0 | 0 | 1 (0.2) | 1 |
| Respiratory, thoracic and mediastinal disorders | 1 (0.4) | 1 | 0 | 0 | 1 (0.2) | 1 |
| Dyspnoea | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Irritated throat | 1 (0.4) | 1 | 0 | 0 | 0 | 0 |
| Infections and infestations | 1 (0.4) | 1 | 0 | 0 | 0 | 0 |
| Rhinitis | 1 (0.4) | 1 | 0 | 0 | 0 | 0 |
| Ear and labyrinth disorders | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Pruritus in the ear | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| General disorders and changes in administration site | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Poorly defined disorder | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Ocular disorders | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Pruritus in the eye | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Psychiatric disorders | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
| Anxiety | 0 | 0 | 0 | 0 | 1 (0.2) | 1 |
The list of adverse events is presented using the system organ class and preferred terms of the Medical Dictionary for Regulatory Activities
aNo differences were identified between age groups (p > 0.05), except for the total number of cases in adolescents, significantly lower than in the adult group (p = 0.0012)