Table 7.

Incidence (events per patient-year) of acute respiratory-related serious adverse events,^a adjusted for length of time on treatment

	IND 75 n = 543	IND 150 n = 2745	IND 300 n = 1422	IND 600 n = 584	IND DPIb n = 6615	FOR n = 556	SLM n = 1010	TIO n = 842	PBO n = 2484
Total patient-years	108.98	865.25	747.38	395.23	2381.78	396.21	279.64	179.39	940.98
Acute respiratory-related events	0.06	0.05	0.07	0.04	0.06	0.10	0.04	0.04	0.06
COPD-related	0.05	0.05	0.06	0.03	0.05	0.09	0.04	0.03	0.06
Pneumonia-related	0.03	0.01	0.02	0.01	0.01	0.02	0.01	0.02	0.01
Hazard ratio (95% CI) vs placebo for time to first acute respiratory event	1.37 (0.49, 3.78)	0.84 (0.51, 1.40)	1.05 (0.70, 1.59)	0.61 (0.33, 1.13)	0.93 (0.69, 1.24)	1.28 (0.78, 2.09)	0.94 (0.41, 2.12)	0.64 (0.20, 2.07)

Notes: Data from randomized, blinded treatment arms in studies of 7 days’ duration or longer in patients with COPD; events were categorized by an independent adjudication committee who reviewed narratives for each event but who were blinded to treatment;

^adefined as events due to acute worsening of underlying condition and involving hospitalization (admission or emergency room visit >24 h in duration), intubation (endotracheal intubation for mechanical ventilation for treatment of acute hypoxemic or hypercapneic respiratory failure) or death; acute events could be classified as related to COPD or pneumonia (as shown) or asthma (no events classified as such);

^ball patients receiving indacaterol via single-dose dry powder inhaler (includes 179 patients receiving indacaterol doses of 18.75 and 37.5 μg in dose-ranging studies).

Abbreviations: IND, indacaterol; FOR, formoterol; SLM, salmeterol; TIO, tiotropium; PBO, placebo; COPD, chronic obstructive pulmonary disease; CI, confidence interval; n, number.