Clinical Study Report - Calidad de Información CFR

7) Females aged over 65 with one type B lesion characteristic* 4 1 1.0000 b)
8) Diabetics with one lesion type B characteristic* 6 6 0.2018 b)
1)
2)
3)
4)
* The Coronary arteriostenosis ACC/AHA classification defined by angiography
a) P-value from Chi-square test b) Fisher’s exact test
Table 11.2.1:3 Distribution of Subjects by Diseases (can select more then one item)-PP
Items
Ischemic ST change in electrocardiogram plus being refractory to drug treatment in
resting phase orwith recurrent angina pectoris
Ischemic ST change in electrocardiogram among post-infarction angina patients within
7 days after myocardial infarction attack that is refractory to drug treatment
Acute Q-Wave myocardial infarction within 12 hours after the attack, which require
direct intervention procedure
Acute Q-Wave myocardial infarction within 12 hours after the attack, which require
another procedure after failure to thrombolytic therapy
Clotinab
(N= 76)
ReoPro ®
(N= 36)
CSR_Clotinab_II 48
Ver. 1.0_Eng
P-value
16 8 0.8880 a)
12 6 0.9060 a)
5 3 0.7103 b)
4 0 0.3034 b)
5) Two type B lesion characteristics* 27 9 0.2653 a)
6) One type C lesion characteristic* 41 20 0.8732 a)
7) Females aged over 65 with one type B lesion characteristic* 4 1 1.0000 b)
8) Diabetics with one lesion type B characteristic* 5 6 0.1700 b)
* The Coronary arteriostenosis ACC/AHA classification defined by angiography
a) P-value from Chi-square test b) Fisher’s exact test
Table 11.2.1:4 Subject demographics (ITT, I)
Demographic Variable Clotinab ReoPro ® Total P-value
N 84 40
Sex
124
Male 68 ( 81.0%) 30 ( 75.0%) 98 ( 79.0%) 0.4466 2)
Female 16 ( 19.0%) 10 ( 25.0%) 26 ( 21.0%)
Age (year)
N 84 40 124
Mean 58.7 59.0 58.8
Median 60.0 60.0 60.0 0.8931 1)
SD 10.57 10.47 10.50
Min 30.0 37.0 30.0