Clinical Study Report - Calidad de Información CFR

Figure 10.1:1 Disposition of subjects
N=1
PCI failure
N=31
Patients ISU301 treated
N=30
Completed
N=76(ISU301)
PP
DISPOSITION OF PATIENTS
N=51
Completed
N=124
Patients screened
N=52
ISU301
treated
N=53
ISU301
N=1
Withdrawal
N=52) N=1
N=8, Major violation
1) N=23) 10.2. Protocol deviations
N=93
Patients randomized
N=1
Withdrawal
(SF but RDZ)
N=40
ReoPro
N=40
Completed
N=36(ReoPro)
PP
N=4, Major violation 4)
Protocol deviations were reviewed at a blind meeting (08-Feb-2006) after database lock(08-
Feb-2006). Details of protocol deviations related to the efficacy endpoint were recorded in the
minutes of “Protocol Deviation Meeting” (See Appendix 16.2.2).
There were 12 subject with major protocol deviation, one 1) was for CABG treatment after PCI
failure, Five Clotinab patients 2) who completed the trial were considered to be major protocol
deviations; of the five, 4 patients did not clear ‘exclusion criteria No.17’ , and 1 patient made
the study-completion return visit on Day10. rather than on Day 30. Two 3) patients dropped out
of the study: 1 subject withdrew the consent on Day 2, 1 randomized subject was dropped out
who should have been a screening-failure. Four ReoPro ® patients 4) were considered major
protocol violations; 3 subjects did not clear ‘exclusion criteria No.17’, and 1 subject was given a
deviant amount of the drug because of an accidental disconnection of IV line during IP
administration. Details are shown in Figure 10.1:1 and Table 10.2:1.
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