Clinical Study Report - Calidad de Información CFR

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Sponsor: ISU ABXIS Co.,Ltd Study number: Clotinab_II Version date: 08-MAR-2006 Name of finished drug : Name of activeingredient : Study period : Clotinab Abciximab 17-MAY-2005 ~ 01-DEC-2005 Safety results dropped significantly by about 24-27%, depending on the analysis population, from the baseline. Three ReoPro ® patients experienced major bleeding event. The major bleeding rate is signifcantly higher in the ReoPro ® group than in the Clotinab group. The intention of this clinical study is not designed to compare the efficacy or safety of Clotinab and ReoPro ® in patients undergoing the PCI procedure. Thus we do not make a statement about which treatment is more effective and safer. Nevertheless we can conclude that Clotinab is effective and safe in preventing the MACE in patients undergoing the PCI procedure. Based on TIMI criteria, no major bleeding occurred in Clotinab, but 3 subjects (7.50%) experienced major bleeding in ReoPro ® . The number of subjects with minor bleeding was 11(13.25%) for Clotinab and 5(12.50%) for ReoPro ® . The number of subjects with clinically insignificant bleeding was 11(13.25%) for Clotinab and 9(22.50%) for ReoPro ® . Number of patients with overall bleeding based on TIMI criteria showed no significant difference between Clotinab and ReoPro ® in each time point. (See Table 12.2:2) However number of patients with major bleeding showed significant difference(p=0.0326). No significant results were reported in thrombocytopenia, change in Hb/Hct, HACA, adverse event, laboratory data. Serious adverse events were occurred to 7 subjects[{Clotinab 3(3.61%), 95% exact C.I.(0.75%, 10.20%)}, {ReoPro ® 4(10.00%), 95% exact C.I.(2.79%, 23.66%)}] as follows. Prolongation of existing hospitalization: 2 patients, lifethreatening: 1 subject in Clotinab. Death: 2 subjects, life-threatening: 2 subjects in ReoPro ® . But Investigators concluded these 7 cases were not related to study drug, and there was no significant difference between Clotinab and ReoPro ® in SAE occurrence rate(P=0.1521). CSR_Clotinab_II 10 Ver. 1.0_Eng
Sponsor: ISU ABXIS Co.,Ltd Study number: Clotinab_II Version date: 08-MAR-2006 Name of finished drug : Name of activeingredient : Study period : Clotinab Abciximab 17-MAY-2005 ~ 01-DEC-2005 Conclusion Clotinab is expected to be effective to prevent ischemic heart complications for high-risk patients who undergo Percutaneous Coronary Intervention(PCI). The probability of MACE onset in Clotinab is estimated to be below 5%. There was no clinically significant result in safety variables. In conclusion, Clotinab will be a effective medicine to prevent ischemic cardiac complications for high-risk patients who undergo Percutaneous Coronary Intervention. CSR_Clotinab_II 11 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 7 and 8: Sponsor: ISU ABXIS Co.,Ltd Study nu
Page 9: Sponsor: ISU ABXIS Co.,Ltd Study nu
Page 13 and 14: 9.5.1. Efficacy and safety measurem
Page 15 and 16: LIST OF IN-TEXT TABLES & FIGURE TAB
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
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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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