Table 4.

Characteristics of Published Phase-4 Clinical Trials of Moxifloxacin^a

First author	Journal	No. subjects (% women)	Age	Research focus	Objective	Limiting omission
Grassi et al.175 USA	J Chemother (2002)	423 (21.3)	69.3±8.4	AECB	To compare the efficacy and tolerability of a 5-day treatment course with oral MXF vs a 7-day course with intramuscular ceftriaxone in 476 patients with acute exacerbations of chronic bronchitis, and to conduct a cost minimization analysis of the two treatments from the perspectives of both the Italian National Health Service and society	Sex not included in the design Not enough women
Miratvilles et al.176 Spain	Int J Clin Pract (2001)	5,736 (35.4)	66	AECB	To examine the clinical effect of oral MXF on patients' signs and symptoms of AECB	Sex not included in the design Not enough women
Lorenz et al.177 USA	J Int Med Res (2001)	332 (46.1)	16–93	AECB	To compare with the macrolides azithromycin, clarithromycin and roxithromycin in a cohort study to assess clinical, safety, and health-related outcomes of these antimicrobials in general practice settings	Enough women, sex was not considered in the design or data analysis
Koch et al.178 USA	Clin Drug Investig (2004)	1,146 (47.3)	54.3±18.2	CAP	To assess the efficacy, safety and tolerability of oral MXF in outpatients with respiratory tract infections treated in general practices in Germany with the focus on CAP	Sex analysis was performed Sex not considered in the design
Landen et al.179 Germany	J Int Med Res (2001)	15,959 (48.7)	14–60	CAP	To study of the speed, efficacy and tolerability of MXF when used in clinical practice for the treatment of CAP or AECB	Enough women, sex was not considered in the design or data analysis
Barth et al.180 Germany	Clinical Drug Investigation (2005)	1,749 (43.5)	43.4±14.3	Pneumonia	To investigate the efficacy, safety, and tolerability of sequential i.v./o.p. therapy with MXF in pneumonia under general hospital treatment conditions.	Enough women, sex was not considered in the design or data analysis
Liu et al.181 China	Int J Clin Pract (2007)	3,184 (41.0)	20–79	Respiratory tract infections	To assess the efficacy and tolerability of MXF post marketing	Sex analysis performed Sex not considered in the design.
Chen et al.182 China	Clin Drug Investig (2006)	855 (41.1)	50.4±18.5	Respiratory tract infections	To assess the efficacy, safety and tolerability of oral MXF in patients with respiratory tract infections treated by attending physicians in routine clinical practice in China	Sex analysis performed Sex not considered in the design
Faich et al.183 USA	Ann Pharmacother (2004)	18,299 (61.9)	6–97	Respiratory tract infections	To further investigate MXF's general and cardiac safety and evaluate its efficacy in the community practice setting in a large surveillance study	Enough women, sex was not considered in the design or data analysis
Elies et al.184 Germany	Clin Drug Investig (2004)	2,405 (56.8)	43.4±14.3	Sinusitis	To assess the efficacy, safety and tolerability of MXF in patients with respiratory tract infections treated in general practice in Germany	Enough women, sex was not considered in the design or data analysis

^aOrdered by research focus and percentage of women participating in the clinical trials.

Phase 4: postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use.