TABLE 6.

Exploratory subgroup analyses of relative change in forced expiratory volume in 1 s (FEV₁) from baseline to 56 days

	Subjects n	Estimate	FEV1# %	se	p-value
Modified ITT	56	0.0331	3.3	0.0259	0.2074
Modified ITT with study drug compliance ≥100%	29	−0.0137	−1.4	0.0250	0.5869
Modified ITT with study drug compliance <100%	27	0.0854	8.5	0.0449	0.0690
Modified ITT age ≤25 years	13	0.0953	9.5	0.0718	0.2115
Modified ITT age >25 years	43	−0.0072	−0.7	0.0259	0.7827
Modified ITT on tobramycin	15	0.1585	15.8	0.0522	0.0095
Modified ITT not on tobramycin	41	−0.0058	−0.6	0.0271	0.8330
Modified ITT on aztreonam	13	0.0836	8.4	0.0505	0.1264
Modified ITT not on aztreonam	43	0.0361	3.6	0.0306	0.2447
Modified ITT on antibiotics and with study drug compliance <100%	24	0.1101	11.0	0.0460	0.0257
Modified ITT on continuous inhaled antibiotics	40	0.0591	5.9	0.0295	0.0521
Modified ITT on continuous inhaled antibiotics and with study drug compliance <100%	19	0.1282	12.8	0.0501	0.0204
Modified ITT on tobramycin and with study drug compliance <100%	9	0.1996	20.0	0.0850	0.0512
Modified ITT with BMI <20 kg·m−2 at screening	16	0.1214	12.0	0.0646	0.0810
Modified ITT with BMI ≥20 kg·m−2 at screening	40	0.0169	1.7	0.0258	0.5171
Modified ITT with FEV1 <55% predicted at screening	21	0.0398	4.0	0.0469	0.4066
Modified ITT with FEV1 55–70% predicted at screening	19	0.0166	1.7	0.0332	0.6230
Modified ITT with FEV1 >70% predicted at screening	16	0.0621	6.2	0.0576	0.2992

Estimates of treatment differences from mixed models. ITT: intention-to-treat population; BMI: body mass index. ^#: percentage change in FEV₁ compared to placebo. Tobramycin treatment was always synchronised in the off-cycle.