Clinical Study Report - Calidad de Información CFR

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12.6.1. Brief summary of Adverse Event ................................................................82 12.6.2. Display of adverse events..........................................................................83 12.6.3. Analysis of adverse events ........................................................................92 12.6.4. Listing of adverse events by patient ...........................................................92 12.7. Serious adverse events, and other significant adverse events.................................92 12.8. <strong>Clinical</strong> laboratory evaluation...............................................................................97 12.8.1. Listing of indivisual laboratory measurements by patient..............................97 12.8.2. Evaluation of each laboratory parameter.....................................................97 12.9. Vital signs, physical findings and other observations related to safety.....................97 12.10. Safety conclusions............................................................................................98 13. Discussion and overall conclusions................................................................................99 14. Reference list............................................................................................................103 15. Tables referred to but not inclu<strong>de</strong>d in the text..............................................................106 CSR_Clotinab_II 14 Ver. 1.0_Eng
LIST OF IN-TEXT TABLES & FIGURE TABLE 6.1: 1 LIST OF ALL PARTICIPATING INVESTIGATORS AND PHARMACISTS........................................20 TABLE 10.1:1 DISPOSITION OF SUBJECTS...................................................................................43 FIGURE 10.1:1 DISPOSITION OF SUBJECTS .................................................................................44 TABLE 10.2:1 LISTING OF SUBJECTS WITH MAJOR PROTOCOL DEVIATION .............................................45 TABLE 11.2.1:1 DISTRIBUTION OF SUBJECTS BY DISEASES (CAN SELECT MORE THEN ONE ITEM)-ITT ..........47 TABLE 11.2.1:2 DISTRIBUTION OF SUBJECTS BY DISEASES (CAN SELECT MORE THEN ONE ITEM)-FAS .........47 TABLE 11.2.1:3 DISTRIBUTION OF SUBJECTS BY DISEASES (CAN SELECT MORE THEN ONE ITEM)-PP ...........48 TABLE 11.2.1:4 SUBJECT DEMOGRAPHICS (ITT, I)........................................................................48 TABLE 11.2.1:4 SUBJECT DEMOGRAPHICS (ITT, II).......................................................................50 TABLE 11.2.1:5 SUBJECT DEMOGRAPHICS (FAS, I) .......................................................................51 TABLE 11.2.1:5 SUBJECT DEMOGRAPHICS (FAS, II)......................................................................52 TABLE 11.2.1:6 SUBJECT DEMOGRAPHICS (PP, I) .........................................................................53 TABLE 11.2.1:6 SUBJECT DEMOGRAPHICS (PP, II)........................................................................54 TABLE 11.2.2:1 PRE-TRIAL INTERVIEW (ITT)..............................................................................55 TABLE 11.2.2:2 PRE-TRIAL INTERVIEW (FAS) .............................................................................56 TABLE 11.2.2:3 PRE-TRIAL INTERVIEW (PP) ...............................................................................57 TABLE 11.2.2:4 MEDICAL HISTORY (ITT) ..................................................................................58 TABLE 11.2.2:5 MEDICAL HISTORY (FAS)..................................................................................59 TABLE 11.2.2:6 MEDICAL HISTORY (PP) ...................................................................................60 TABLE 11.3.1:1 MAJOR ADVERSE CARDIAC EVENT (MACE)-PP .......................................................62 TABLE 11.3.1:2 MAJOR ADVERSE CARDIAC EVENT (MACE) IN THE SUBGROUPS-PP...............................63 TABLE 11.3.1:3 MAJOR ADVERSE CARDIAC EVENT (MACE)-ITT ......................................................63 TABLE 11.3.1:4 MAJOR ADVERSE CARDIAC EVENT (MACE) IN THE SUBGROUPS-ITT .............................64 TABLE 11.3.1:5 MAJOR ADVERSE CARDIAC EVENT (MACE)-FAS......................................................64 TABLE 11.3.1:6 MAJOR ADVERSE CARDIAC EVENT (MACE) IN THE SUBGROUPS-FAS.............................65 TABLE 11.3.2:1 NEW CHANGE IN ELECTROCARDIOGRAM WHICH INDICATES THE STATUS OF ISCHEMIA -PP.....66 TABLE 11.3.2:2 THE CHANGE ELECTROCARDIOGRAM BETWEEN PRE- AND POST- INJECTION OF THE INVESTIGATIONAL DRUG –PP ............................................................................................67 TABLE 11.3.2:3 NEW CHANGE IN ELECTROCARDIOGRAM WHICH INDICATES THE STATUS OF ISCHEMIA –ITT...68 TABLE 11.3.2:4 THE CHANGE ELECTROCARDIOGRAM BETWEEN PRE- AND POST- INJECTION OF THE INVESTIGATIONAL DRUG -ITT............................................................................................69 TABLE 11.3.2:5 NEW CHANGE IN ELECTROCARDIOGRAM WHICH INDICATES THE STATUS OF ISCHEMIA –FAS ..70 TABLE 11.3.2:6 THE CHANGE ELECTROCARDIOGRAM BETWEEN PRE- AND POST- INJECTION OF THE CSR_Clotinab_II 15 Ver. 1.0_Eng
Page 1 and 2: Clinical Study Report A multicentre
Page 3 and 4: 1.2. Signature page WRITER CSR Writ
Page 5 and 6: Sponsor: ISU ABXIS Co.,Ltd Study nu
Page 13: 9.5.1. Efficacy and safety measurem
Page 17 and 18: 4. List of abbreviations and defini
Page 19 and 20: Coordination investigator : Prof. Y
Page 21 and 22: Abciximab, one of platelet glycopro
Page 23 and 24: Test items Study flow chart * Women
Page 25 and 26: (3) Culprit lesion in the bypass gr
Page 27 and 28: Product Name Clotinab Generic Name
Page 29 and 30: Biostatisitician Kyoung-A Kim, Byeo
Page 31 and 32: The primary efficacy endpoint is th
Page 33 and 34: 9.5.1.2. Safety measurement assesse
Page 35 and 36: v) None: AE occurs independently fr
Page 37 and 38: 9.7.1. Statistical and Analytical P
Page 39 and 40: lood cell (RBC) infused within 48 h
Page 41 and 42: H0 : p ≥ 0.2 versus HA : p < 0.2
Page 43 and 44: Table 10.1:1 Disposition of Subject
Page 45 and 46: Table 10.2:1 Listing of subjects wi
Page 47 and 48: 1) 2) 3) 4) next 53 patients with r
Page 49 and 50: Max 77.0 77.0 77.0 Height (cm) N 82
Page 51 and 52: Table 11.2.1:5 Subject demographics
Page 53 and 54: Table 11.2.1:6 Subject demographics
Page 55 and 56: Medical history data are summarized
Page 57 and 58: Table 11.2.2:3 Pre-trial interview
Page 59 and 60: Table 11.2.2:5 Medical History (FAS
Page 61 and 62: 11.3. Efficacy results, tabulations
Page 63 and 64: Angina (%) Table 11.3.1:2 Major Adv
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Angina (%) Emergency revascularizat
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Visit 12hr Baseline C.I. : confiden
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Visit 12hr Baseline Table 11.3.2:4
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Visit 12hr Table 11.3.2:6 The chang
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12. Safety evaluation Eighty-three
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Bleeding Number of Patients Table 1
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Table 12.2:5 Number of patients wit
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Hb Hct Table 12.4:1 Hb/Hct - Clotin
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egion-specific) or C region (consta
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Clotinab (N=83) ReoPro ® (N=40) Ta
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Body system Blood and lymphatic sys
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Body system CSR_Clotinab_II 87 Ver.
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Table 12.6.2:2 Number observed and
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Body system CSR_Clotinab_II 91 Ver.
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The subject Y056 (KMC, male, 57 yea
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Subject ID Table 12.7:2 Subjects wi
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12.8. Clinical laboratory evaluatio
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13. Discussion and overall conclusi
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The intention of this clinical stud
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14. Reference list (1) 혈소판
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(28) Willerson JT, Golino P, Eidt J
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Table 15. 1 Medication administered
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Table 15. 2 Concomitant medication
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Table 15. 3 Medication - administer
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Table 15. 5 Medication - administer
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Table 15. 7 Disposition of subjects
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Table 15. 9 The rate of adverse eve
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Body system/Preferred term Number o
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Table 15. 10 Number observed and ra
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Body system Gastrointestinal disord
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General disorders and administratio
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General disorders and administratio
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Body system Hypoaesthesia 3(3.61%)
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Body system Vascular disorders Ging
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Body system Gastrointestinal disord
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Body system Face oedema 1(2.50%) Y0
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Body system Psychiatric disorders S
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Subject list of all adverse events
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Table 15. 13 Laboratory Data WBC RB
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PLT Neutro. (seg) Table 15. 13 Labo
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Table 15.13 Laboratory Data (Contin
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Table 15. 13 Laboratory Data (Conti
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SGOT (AST) SGPT (ALT) Table 15. 13
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Table 15. 14 Cardiac Marker Clotina
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Table 15. 15 Urinalysis-Clotinab IT
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Table 15. 16 Urinalysis-ReoPro ® I
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Table 15. 17 Coagulation ITEM(APTT
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Table 15. 18 Vital sign (continued)
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Table 15. 19 Physical examination-C
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Table 15. 20 Physical examination -
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Table 15. 21 Listing of subjects wi
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NO. Subject ID Group Comment 54 Y03
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Deviation type N : no ACT measureme
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Clinical Study Report - Calidad de Información CFR

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