Table 3.

Incidence of on-treatment AEs (ITT population).

	FF/UMEC/VI		TIO
	N = 400		N = 400
	n (%)	Rate [#]	n (%)	Rate [#]
Total treatment exposure, patient-years	90.5		92.0
AEs
Any	127 (32)	2609.2 [236]	115 (29)	2695.2 [248]
Drug related	11 (3)	199.0 [18]	4 (1)	228.2 [21]
Leading to permanent discontinuation or study withdrawala	7 (2)	110.6 [10]	3 (<1)	32.6 [3]
SAEs
Any	13 (3)	187.9 [17]	10 (3)	130.4 [12]
Drug related	0	–	0	–
Leading to permanent discontinuation or study withdrawal	4 (1)	44.2 [4]	3 (<1)	32.6 [3]
Fatal	2 (<1)	22.1 [2]	1 (<1)	10.9 [1]
AESIs
Cardiovascular effects	11 (3)	143.7 [13]	11 (3)	195.6 [18]
Decreased BMD and associated fractures	2 (<1)	22.1 [2]	0	–
LRTI excluding pneumonia	0	–	1 (<1)	10.9 [1]
Pneumonia	3 (<1)	33.2 [3]	3 (<1)	32.6 [3]

Rate is the number of events per 1000 patient-years, calculated as the number of events × 1000 divided by the total treatment exposure.

# number of events, AE adverse event, AESI adverse event of special interest, BMD bone mineral density, COPD chronic obstructive pulmonary disease, FF fluticasone furoate, ITT intent-to-treat, LRTI lower respiratory tract infection, SAE serious adverse event, TIO tiotropium, UMEC umeclidinium, VI vilanterol.

^aAEs leading to permanent discontinuation or study withdrawal included pneumonia (FF/UMEC/VI n = 1 [<1%]; TIO n = 1 [<1%]), oral fungal infection (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), postoperative wound infection (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), hemorrhagic stroke (FF/UMEC/VI n = 0; TIO n = 1 [<1%]), ischemic stroke (FF/UMEC/VI n = 0; TIO n = 1 [<1%]), tremor (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), cardiac arrest (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), palpitations (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), asthenia (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), insomnia (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), COPD (FF/UMEC/VI n = 1 [<1%]; TIO n = 0), and hyperhidrosis (FF/UMEC/VI n = 1 [<1%]; TIO n = 0).