Table 5.
DIASAFE adverse events relating to nasal irritation
| Classification type | Severity* | Age group 2–11 years (N=191) Patients (%) |
Age group 12-<16 years (N=35) Patients (%) |
Overall (N=226) Patients (%) |
|---|---|---|---|---|
| Patients with any nasal irritation TEAE | Overall | 38 (19.9) | 8 (22.9) | 46 (20.4) |
| Mild | 36 (18.8) | 8 (22.9) | 44 (19.5) | |
| Moderate | 1 (0.5) | 0 | 1 (0.4) | |
| Severe | 0 | 0 | 0 | |
| Unknown | 1 (0.5) | 0 | 1 (0.4) | |
| Persistent and troublesome Sneezing | Overall | 5 (2.6) | 4 (11.4) | 9 (4.0) |
| Mild | 5 (2.6) | 4 (11.4) | 9 (4.0) | |
| Redness | Overall | 1 (0.5) | 0 | 1 (0.4) |
| Mild | 1 (0.5) | 0 | 1 (0.4) | |
| Itching | Overall | 20 (10.5) | 2 (5.7) | 22 (9.7) |
| Mild | 19 (9.9) | 2 (5.7) | 21 (9.3) | |
| Moderate | 1 (0.5) | 0 | 1 (0.4) | |
| Nasal discharge | Overall | 0 | 1 (2.9) | 1 (0.4) |
| Mild | 0 | 1 (2.9) | 1 (0.4) | |
| Other—nasal discomfort | Overall | 4 (2.1) | 1 (2.9) | 5 (2.2) |
| Mild | 3 (1.6) | 1 (2.9) | 4 (1.8) | |
| Unknown | 1 (0.5) | 0 | 1 (0.4)† | |
| Other—sneezing | Overall | 11 (5.8) | 3 (8.6) | 14 (6.2) |
| Mild | 11 (5.8) | 3 (8.6) | 14 (6.2) | |
| Local tenderness | Overall | 0 | 0 | 0 |
| Swelling | Overall | 0 | 0 | 0 |
Treatment emergent adverse events (TEAEs) are defined as adverse events that started or worsened after first administration of the investigational medicinal product.
TEAEs relating to nasal irritation were identified and classification type assigned to each event prior to database lock.
If a patient experienced more than one TEAE relating to nasal irritation, the patient is counted once for each classification type, at the highest severity. MedDRA dictionary V.13.0 was used for coding adverse events. N=the number of patients in the population.
(%)=patients/N×100.
*Severity only displayed when an event was seen at that severity.
†Patient reported ‘nasal irritation’ with no classification or severity noted.