Table 4.

Event Counts for Outcomes

Outcomes		Days Meeting Criteria	Events Detected	Event Rate/Year
Report*	= Telephone report of exacerbation	3	3	0.42
A1	= Exacerbation detected by Anthonisen Class 1 criteria (event = at least 2 consecutive days of positive Anthonisen Class 1 criteria)	29	13	1.81
A2	= Exacerbation detected by Anthonisen Class 2 criteria (event = at least 2 consecutive days of positive Anthonisen Class 2 criteria)	160	48	6.69
MA	= Exacerbation detected by Modified Anthonisen criteria (event = at least 2 consecutive days of positive Modified Anthonisen criteria)	314	63	8.79
Antibiotic	= Reported antibiotic use	4	4	0.56
Steroid	= Reported systemic corticosteroid use	4	4	0.56

Notes: *Telephone report of exacerbation with estimated number of exacerbation days. One subject withdrew from the study on the first day of one of these exacerbation events. The event rate was based on 7.17 patient-years of monitoring. A1, A2, MA based on event count using symptom score > (7-day average score + 1.645*SD). A1: Exacerbation detected by Anthonisen Class 1 criteria (increased 3 of 3: dyspnea, sputum volume, sputum purulence). A2: Exacerbation detected by Anthonisen Class 1 criteria (increased at least 2 of 3: dyspnea, sputum volume, sputum purulence). MA: Modified Anthonisen criteria, if at least 2 major symptoms positive (dyspnea, sputum volume, sputum purulence) or at least 1 major and 1 minor symptom (wheezing or coughing).