Table 4.

Subjects Required per Arm to Detect a 0.6 Hazard Ratio in a 6-Month Controlled Study using Either Treatment with “Any” or IV Antibiotics for Exacerbation as an Endpoint

							FEV1 Range (% predicted)
	All Patients		Age < 6 yrs		≥ 100		70 to <100		40 to <70		<40
	“Any”	IV	“Any”	IV	“Any”	IV	“Any”	IV	“Any”	IV	“Any”	IV
All Patients	202	355	360	745	332	959	212	450	129	195	105	138
Age Group
6-12 yrs	239	473	-	-	377	1,031	248	556	143	213	103	139
13-17 yrs	161	288	-	-	261	851	188	401	121	183	95	121
18-24 yrs	127	191	-	-	214	630	157	288	119	175	102	127
≥ 25 yrs	134	204	-	-	197	686	193	389	136	216	112	152
Sex
Male	217	398	374	754	348	1,101	234	535	139	217	111	152
Female	188	320	347	736	315	833	193	386	121	179	99	124
WFA Percentilea
<25th	175	283	315	572	317	868	211	429	123	183	103	131
≥25th	231	455	399	939	339	1010	214	469	138	214	113	159
Signs and Symptomsa
Daily Cough	151	241	260	480	242	666	175	336	121	180	103	134
Daily Sputum	132	198	206	352	207	514	164	298	119	174	103	132
Clubbing	160	263	272	528	305	887	192	392	123	185	103	134
Crackles	123	177	192	279	273	615	163	299	114	168	102	132
Wheeze	165	264	315	557	324	912	197	376	126	190	116	163
Pulmonary Exacerbation Historyb
None	305	778	471	1258	406	1529	282	807	185	370	152	267
One	155	260	251	436	204	439	155	294	126	200	111	154
Two	109	150	181	268	133	252	113	173	94	124	96	120
Three or more	86	103	135	188	117	168	88	111	81	96	78	87
P. aeruginosa Culture Historyc
All negative	327	608	458	901	496	1321	302	620	162	241	127	166
Any positive	150	257	243	535	229	708	170	362	120	179	101	131
Indeterminated	176	358	271	679	240	740	190	482	140	244	120	170
Intermittente	198	374	273	643	290	825	197	418	131	199	99	121
Chronicf	130	207	187	355	199	639	154	309	112	162	97	125

^aAs recorded at the index visit

^bNumber of pulmonary exacerbations treated with IV antibiotics in the 12 months prior to the index visit

^cRecorded in the 12 months prior to the index visit

^dOnly one culture result reported

^e≤50% of cultures positive

^f>50% of cultures positive