Table 8.

Percentages of patients with notable values for potassium (low) and glucose (high), blood pressures, pulse, and QTc interval (prolonged) at any time postbaseline^a during the first 3 months of treatment

	IND 75 n = 449	IND 150 n = 2611	IND 300 n = 1157	IND 600 n = 547	FOR n = 556	SLM n = 895	TIO n = 1214	PBO n = 2012
Potassium <3.0 mmol/L	0.2	0.1s	0.2	0	0	0.2	0	0.2
Glucose >9.99 mmol/L	4.9	4.0	5.1	6.4	4.7	5.5	3.5	5.4
Systolic blood pressure – highb	0.5	0.6	0.9	2.0	1.1	0.5	1.0	1.1
Systolic blood pressure – lowc	0.9	0.5	1.4	1.1	1.1	0.9	0.6	1.1
Diastolic blood pressure – highd	1.6	0.6	0.6	0.9	0.5	0.7	1.6	1.0
Diastolic blood pressure – lowe	0.5	0.5	1.0	1.1	0.9	0.3	0.4	0.6
Pulse rate – highf	0.2	0.2	0.3	0.4	0.4	0.1	0.1	0.3
Pulse rate – lowg	1.3	0.6	0.5	0.2	0.4	0.3	0.7	1.1
QTc interval
>450 ms (males) or 470 ms (females)	4.0	2.7	4.0	4.6	3.4	1.0	3.4	2.7
>500 ms	0	0.1	0	0	0	0	0.2	0
Increase from baseline 30–60 ms	7.1	6.0	7.5	6.9	6.5	4.7	6.2	5.3
Increase from baseline >60 ms	0	0.1	0.1	0.2	0	0.3	0.1	0.3

Notes:

^aMeasured on Day 1 and after 12 weeks of treatment in one study, on Day 1 and after 2 and 12 weeks in five studies, on Day 1 and after 4 and 12 weeks in two studies, and on Day 1 and after 4, 8, and 12 weeks in two studies; one study measured ECG and vital signs on Day 1 and Weeks 2 and 12 and laboratory evaluations on Weeks 4 and 12;

^b≥180 mmHg and increase from baseline by ≥20 mmHg, or >200 mmHg;

^c<75 mmHg, or ≤90 mmHg and decrease from baseline by ≥20 mmHg;

^d≥105 mmHg and increase from baseline by ≥15 mmHg, or >115 mmHg;

^e<40 mmHg, or ≤50 mmHg and decrease from baseline by ≥15 mmHg;

^f≥120 bpm and increase from baseline by ≥15 bpm, or >130 bpm;

^g<40 bpm, or ≤50 bpm and decrease from baseline by ≥15 bpm.

Abbreviations: IND, indacaterol; FOR, formoterol; SLM, salmeterol; TIO, tiotropium; PBO, placebo; n, number.