Clinical Study Report - Calidad de Información CFR

(5) Adverse Event
The table summarized for the adverse events which occurred after the administration of the
investigational drug or comparator drug. Other adverse events were reported in the listing. All
adverse event were coded by system organ class (SOC) and preferred term(PT) using
MedDRA(Medical Dictionary for Regulatory Activities)8.0 ® . Frequency and proportion by these
codes were generated in two groups. For the relationship with the study drug, frequency was
calculated by group for adverse events which were related to the study drug (Definite, Probable,
Possible) and were not related to the study drug (Improbable, None, Unknown). Frequency,
proportion (95% exact C.I.) were presented for the number of adverse event and the number
of subjects with adverse events occurred at least once. Serious adverse events were
summarized using the following category: adverse event results in death or stopping of study
drug.
(6) Laboratory data
The descriptive statistics (mean, standard deviation, median, minimum, maximum) were
presented by group and visit for continuous variables such as hematology, serum chemistry and
vital sign. Frequency and proportion of status (normal/clinically insignificant abnormal/clinically
significant abnormal) in each visit compared to screening or baseline were described for
categorical variables such as urine test status.
9.7.1.5. Missing data
If a subject terminated the trial early or did not make the final visit, the efficacy and safety data
should be collected as much as possible. If the efficacy data could not be obtained, they were
treated as missind data.
9.7.2. Determination of sample size
ReoPro ® developed abroad was approved in the country and is currently on the domestic
market. Clotinab, a platelet IIb/IIIa inhibitor, which was developed by ISUABXIX Ltd. has same
active ingredient as ReoPro ® and is expected to have a similar efficacy to ReoPro ® .
The clinical trial is designed to prove that event rate of the primary efficacy endpoint of Clotinab
is below 20%. The followings are the statistical null hypothesis and alternative hypothesis in the
phase Ⅱ of the clinical trial on Clotinab.
CSR_Clotinab_II 40
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