Clinical Study Report - Calidad de Información CFR

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ITT subjects to whom the study drug had been administered make up the FAS. All the FAS subjects who had completed the trial without serious protocol violation became the PP set. The safety population consisted of the study participants to whom the study drug was administered even partially. The analysis was done according to the drugs actually received. Of 124 subjects including 31 Clotinab patients from the stage 1, 84 subjects received Clotinab, and 40 received ReoPro ® . The ITT set consisited of all 124 patients. The FAS consisted of 123, 83 Clotinab patients and 40 ReoPro ® patients. The PP set consisted of 112 patients, 76 Clotinab patients and 36 ReoPro ® patients. The FAS population was the safety analysis set. Details are shown in Appendix 16.2.2. 11.2. Demographic and other baseline characteristics 11.2.1. Demographic characteristics The distribution of subjects by diseases based on the coronary arteriostenosis ACC/AHA criteria <strong>de</strong>fined by angiography is as follows: 67 patients had one type C lesion characteristic,; 40 patients had two type B lesion characteristics; 26 patients were refractory to drug treatmentin resting phase and with recurrent angina pectoris, and showed ischemic ST change in electrocardiogram; and 22 post-infarction angina patients were within 7 days after myocardial infarction attack that is refractory to drug treatment, and showed ischemic ST change in electrocardiogram. There was no significant difference in the distribution of disease status between two drug groups (Tables 11.2.1.1-3). Demographic characteristics of study participants were summarized in Table 11.2.1:4. There were 98 male patients and 26 female patients. The mean age was 58.8±10.50, the mean height 165.2±7.82cm and 165.1±8.00cm, and the mean weight was 68.7±12.09kg. There was no significant difference in these variables between two treatment groups. Demographic characteristics for the FAS population and the PP population were summarized in Table 11.2.1:5 and Table 11.2.1.6. There was no significant difference between two different groups in the FAS population or in the PP population. The Clotinab group was recruited in two stages, first 31 patients without randomization and CSR_Clotinab_II 46 Ver. 1.0_Eng
1) 2) 3) 4) next 53 patients with randomization. Characteristics of the first stage patients and the second stage patients are summarized in Table 11.2.1:4. and Table 11.2.1:5 These two groups and the ReoPro ® group do not show any statistically significant difference. Table 11.2.1:1 Distribution of Subjects by Diseases (can select more then one item)-ITT Items Ischemic ST change in electrocardiogram plus being refractory to drug treatment in resting phase or with recurrent angina pectoris Ischemic ST change in electrocardiogram plus post-infarction angina patients within 7 days after myocardial infarction attack that is refractory to drug treatment Acute Q-Wave myocardial infarction within 12 hours after the attack, which require direct intervention procedure Acute Q-Wave myocardial infarction within 12 hours after the attack, which require another procedure after failure to thrombolytic therapy Clotinab (N= 84) ReoPro ® (N= 40) CSR_Clotinab_II 47 Ver. 1.0_Eng P-value 18 8 0.8551 a) 16 6 0.5813 a) 6 4 0.7258 b) 4 2 1.0000 b) 5) Two type B lesion characteristics* 29 11 0.4341 a) 6) One type C lesion characteristic* 45 22 0.8814 a) 7) Females aged over 65 with one type B lesion characteristic* 4 1 1.0000 b) 8) Diabetics with one lesion type B characteristic* 6 6 0.1990 b) 1) 2) 3) 4) * The Coronary arteriostenosis ACC/AHA classification <strong>de</strong>fined by angiography a) P-value from Chi-square test b) Fisher’s exact test Table 11.2.1:2 Distribution of Subjects by Diseases (can select more then one item)-FAS Items Ischemic ST change in electrocardiogram plus being refractory to drug treatment in resting phase or with recurrent angina pectoris Ischemic ST change in electrocardiogram plus post-infarction angina patients within 7 days after myocardial infarction attack that is refractory to drug treatment Acute Q-Wave myocardial infarction within 12 hours after the attack, which require direct intervention procedure Acute Q-Wave myocardial infarction within 12 hours after the attack, which require another procedure after failure to thrombolytic therapy Clotinab (N= 83) ReoPro ® (N= 40) P-value 17 8 0.9504 a) 16 6 0.5620 a) 6 4 0.7266 b) 4 2 1.0000 b) 5) Two type B lesion characteristics* 29 11 0.4093 a) 6) One Type C lesion characteristic* 45 22 0.9349 a)
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 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: Table 10.2:1 Listing of subjects wi
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
Page 65 and 66: Angina (%) Emergency revascularizat
Page 67 and 68: Visit 12hr Baseline C.I. : confiden
Page 69 and 70: Visit 12hr Baseline Table 11.3.2:4
Page 71 and 72: Visit 12hr Table 11.3.2:6 The chang
Page 73 and 74: 12. Safety evaluation Eighty-three
Page 75 and 76: Bleeding Number of Patients Table 1
Page 77 and 78: Table 12.2:5 Number of patients wit
Page 79 and 80: Hb Hct Table 12.4:1 Hb/Hct - Clotin
Page 81 and 82: egion-specific) or C region (consta
Page 83 and 84: Clotinab (N=83) ReoPro ® (N=40) Ta
Page 85 and 86: Body system Blood and lymphatic sys
Page 87 and 88: Body system CSR_Clotinab_II 87 Ver.
Page 89 and 90: Table 12.6.2:2 Number observed and
Page 91 and 92: Body system CSR_Clotinab_II 91 Ver.
Page 93 and 94: The subject Y056 (KMC, male, 57 yea
Page 95 and 96: 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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