Clinical Study Report - Calidad de Información CFR

Case A1. PP population
If nine or fewer patients among seventy six subjects treated with Clotinab experience MACE,
then the MACE onset rate is estimated to be below 20% and Clotinab is considered to be
effective..
Case A2. ITT population
If ten or fewer patients among eighty four subjects treated with Clotinab experience MACE,
then the MACE onset rate is estimated to be below 20% and Clotinab is considered to be
effective
Case A3. FAS population
If ten or fewer patients among eighty three subjects treated with Clotinab experience MACE,
then the MACE onset rate is estimated to be below 20% and Clotinab is considered to be
effective.
Case B
If the number of MACE patients is over the defined number in each population, efficacy of
Clotinab is evaluated after adjusting the critical value based on the MACE onset rate in ReoPro ® .
Secondary efficacy endpoint and analysis
(1) Endpoint
New change in electrocardiogram that indicates the status of ischemia.
(2) Analysis methods
Frequency, proportion and 95% exact C.I. of new changes from pre-administration to postadministration
in electrocardiogram (yes/no) were presented. Fisher’s exact test was performed
to find the differences between two groups. Frequency was presented and McNemar’s test was
applied to determine if the changes in electrocardiogram from pre- to post-administration is
significant.
9.7.1.4. Safety endpoint and analysis
Safety endpoints
(1) Bleeding
According to the TIMI criteria, bleeding is categorized into ‘major bleeding’, ‘minor bleeding’,
or ‘insignificant bleeding’. To measure the quantity of bleeding, the quantity of change in
hemoglobin and hematocrit was adjusted according to whole blood and concentrated red
CSR_Clotinab_II 38
Ver. 1.0_Eng