Table 6.
New signals unmasked by stratification for age
| Drug | Reaction HLT | Overall PRR (95% CI) | Age group, years | Reports in age group | PRR in age group (95% CI) |
|---|---|---|---|---|---|
| Salbutamol, inhaled | Perception disturbances | 1.5 (0.9–2.6) | 0–2 | 6 | 14.8 (6.6–33.0) |
| Salbutamol, inhaled | Cardiac septal defects congenital | 2.0 (0.8–4.7) | 0–2 | 5 | 2.8 (1.2–6.6) |
| Budesonide | Neutropenias | 1.8 (1.0–3.3) | 0–2 | 5 | 3.6 (1.5–8.5) |
| Theophylline | Febrile disorders | 1.1 (0.7–1.7) | 3–11 | 13 | 2.3 (1.4–3.6) |
| Montelukast | Diabetes mellitus (including subtypes) | 1.6 (0.9–3.0) | 3–11 | 11 | 2.3 (1.3–4.2) |
| Omalizumab | Cardiac signs and symptoms NEC | 1.2 (0.7–2.1) | 3–11 | 5 | 2.8 (1.2–6.6) |
| Montelukast | Gastrointestinal atonic and hypomotility disorders NEC | 1.2 (0.7–2.1) | 12–17 | 5 | 2.8 (1.2–6.6) |
CI confidence interval, HLT high-level term, NEC not elsewhere classified, PRR proportional reporting ratio