Table 6.
Patients with serious adverse events (other than lower respiratory tract disorders) before and after the first exacerbation in summer and winter—incidence RRs (after/before) adjusted for time at risk by SOC
| SOC | Summer (N = 1,535) | Winter (N = 2,425) |
|---|---|---|
| All | 1.39 (1.17–1.64) | 1.75 (1.52–2.02) |
| Cardiac | 2.12 (1.46–3.08) | 2.06 (1.55–2.74) |
| Gastrointestinal | 0.95 (0.63–1.43) | 1.76 (1.20–2.58) |
| General and administration sitea | 1.46 (0.81–2.65) | 2.62 (1.57–4.39) |
| Infections and infestationsb | 1.92 (1.06–3.51) | 2.12 (1.33–3.40) |
| Injury, poisoning, procedural | 2.37 (1.17–4.81) | 1.63 (1.02–2.58) |
| Metabolism and nutrition | 1.25 (0.56–2.78) | 1.51 (0.68–3.32) |
| Neoplasms (not lung)b | 1.45 (0.94–2.24) | 1.34 (0.94–1.91) |
| Nervous system | 1.10 (0.67–1.82) | 1.75 (1.13–2.72) |
| Renal and urinary | 3.64 (1.30–10.3) | 1.60 (0.85–3.04) |
| Respiratory system (other)c | 2.35 (1.24–4.47) | 3.58 (2.19–5.84) |
| Respiratory system (upper)c | 1.41 (0.52–3.83) | 2.02 (0.94–4.34) |
| Vascular | 2.44 (1.15–5.17) | 2.05 (1.25–3.36) |
Values are incidence RR (95% CI)
RR rate ratio (after/before), SOC system organ class, CI confidence interval, MedDRA Medical Dictionary for Regulatory Activities
aSOC “General disorders and administration site conditions” includes the cardiac preferred terms chest discomfort, chest pain, edema peripheral, sudden death, edema due to cardiac disease, and cardiac death
bPreferred terms with a secondary relationship to MedDRA SOC respiratory, thoracic, and mediastinal disorders are not included
cAll primary system organ classes are defined by MedDRA with the exception of “Respiratory, thoracic, and mediastinal disorders,” which has been divided into separate classes of respiratory system disorders: Lower, Upper, and Other