Table 2. Primary and secondary trial endpoints.

Parameter	All patients (n  =  494) 1	Gatifloxacin (n  =  249) 1	Ciprofloxacin (n  =  245) 1	Comparison:Estimate (95% CI) 2	p-value 3
Primary endpoint
Overall Treatment Failure	57 (11.5%)	30 (12.0%)	27 (11.0%)	1.0 (−4.7 to 6.7)	0.72
b) Clinical Failure	45 (9.1%)	26 (10.4%)	19 (7.8%)	2.7 (−2.5 to 7.8)	0.30
Symptom > 5 days failure	13 (2.6%)	8 (3.2%)	5 (2.0%)	1.2 (−1.8 to 4.2)	0.42
Fever failure	4 (0.8%)	0 (0%)	4 (1.6%)	−1.6 (3.5 to 0.3)	0.06
b) Microbiological Failure	15 (3.0%)	6 (2.4%)	9 (3.7%)	−1.3 (−4.5 to 1.9)	0.41
Secondary endpoints 4
Fever clearance time (hrs)	12 (0–30)	12 (0–30)	12 (0–28)	1.00 (0.84 to 1.20)	0.98
Bloody diarrhea clearance time (hrs)	24 (17–48)	24 (17–47)	25 (17–48)	1.11 (0.93 to 1.32)	0.26
Diarrhea clearance time (hrs)	61 (40–90)	61 (41–92)	61 (38–90)	0.98 (0.82 to 1.17)	0.84
Total time of illness from study enrolment (hrs)	64 (42–92)	64 (42–93)	64 (41–90)	0.99 (0.83 to 1.18)	0.90
Total time of illness from illness onset (hrs)	95 (66–123)	95 (66–126)	93 (68–120)	0.98 (0.82 to 1.17)	0.83
Follow up
Patients attending follow up (n)	432 (87.4%)	217 (87.1%)	215 (88.8%)	-	-
Diarrhea on follow up (n)	15 (3.5%)	8 (3.7%)	7 (3.3%)	0.4 (−3.2 to 4.1)	0.81
Other symptom on follow up (n)	2 (0.5%)	2 (0.9%)	0 (0%)	0.9 (−0.9 to 2.7)	0.51
Failure on follow up (n)	17 (3.9%)	10 (4. 6%)	7 (3.3%)	1.4 (−2.5 to 5.2)	0.47

¹Summarized as n (%) for proportion data and median (IQR) for time-to event data.

²Estimate corresponds to the absolute risk difference (in%) for proportion data and a hazard ratio for time-to-event data.

³ p-values calculated by chi-squared test for proportional data and by Cox Regression models for time-to-event data.

⁴Time-to-event endpoints calculated from study enrolment (i.e. the first dose of study treatment) unless mentioned otherwise.