Clinical Study Report - Calidad de Información CFR

More documents

Recommendations

Info

1.1. Principal investigator’s signature page PRINCIPAL OR COORDINATING INVESTIGATORS SIGNATURES OR SPONSOR’S RESPONSIBLE MEDICAL OFFICER STUDY TITLE: A multicentre, open-label, therapeutic and exploratory trial to evaluate the safety and efficacy of platelet glycoprotein (GP) IIb/IIIa receptor blocker (Clotinab) in high-risk patients with Percutaneous Coronary Intervention (PCI) STUDY AUTHOR(S): Yang-Soo, Jang; Young-Hak, Kim; Myung-Ho, Jeong I have read this report and confirm that to the best of my knowledge it accurately describes the conduct and results of the study INVESTIGATOR: DATE: Name Signature CSR_Clotinab_II 2 Ver. 1.0_Eng
1.2. Signature page WRITER CSR Writer Biostatistician REVIEWER Study Manager CR Manager Stat Manager APPROVAL Clinical Operation Director Biostatistics Director Sponsor Ae-Jin, Lim LSK Ik-Seong, Choi Date Signature LSK Date Signature Sook-Hyun, Im LSK Ji-Hoon, Hwang LSK Hee-Jeong, Shim Date Signature Date Signature LSK Date Signature Yong-Kwan, Jun LSK Sung-Jae, Kim LSK Mook, Kim Date Signature Date Signature ISU ABXIS Co., Ltd. Date Signature CSR_Clotinab_II 3 Ver. 1.0_Eng
Page 1: Clinical Study Report A multicentre
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 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
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
Page 97 and 98:
12.8. Clinical laboratory evaluatio
Page 99 and 100:
13. Discussion and overall conclusi
Page 101 and 102:
The intention of this clinical stud
Page 103 and 104:
14. Reference list (1) 혈소판
Page 105 and 106:
(28) Willerson JT, Golino P, Eidt J
Page 107 and 108:
Table 15. 1 Medication administered
Page 109 and 110:
Table 15. 2 Concomitant medication
Page 111 and 112:
Table 15. 3 Medication - administer
Page 113 and 114:
Page 115 and 116:
Table 15. 5 Medication - administer
Page 117 and 118:
Page 119 and 120:
Table 15. 7 Disposition of subjects
Page 121 and 122:
Table 15. 9 The rate of adverse eve
Page 123 and 124:
Body system/Preferred term Number o
Page 125 and 126:
Table 15. 10 Number observed and ra
Page 127 and 128:
Body system Gastrointestinal disord
Page 129 and 130:
General disorders and administratio
Page 131 and 132:
General disorders and administratio
Page 133 and 134:
Body system Hypoaesthesia 3(3.61%)
Page 135 and 136:
Body system Vascular disorders Ging
Page 137 and 138:
Body system Gastrointestinal disord
Page 139 and 140:
Body system Face oedema 1(2.50%) Y0
Page 141 and 142:
Body system Psychiatric disorders S
Page 143 and 144:
Subject list of all adverse events
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175 and 176:
Page 177 and 178:
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Table 15. 13 Laboratory Data WBC RB
Page 185 and 186:
PLT Neutro. (seg) Table 15. 13 Labo
Page 187 and 188:
Table 15.13 Laboratory Data (Contin
Page 189 and 190:
Table 15. 13 Laboratory Data (Conti
Page 191 and 192:
SGOT (AST) SGPT (ALT) Table 15. 13
Page 193 and 194:
Page 195 and 196:
Page 197 and 198:
Table 15. 14 Cardiac Marker Clotina
Page 199 and 200:
Table 15. 15 Urinalysis-Clotinab IT
Page 201 and 202:
Table 15. 16 Urinalysis-ReoPro ® I
Page 203 and 204:
Table 15. 17 Coagulation ITEM(APTT
Page 205 and 206:
Table 15. 18 Vital sign (continued)
Page 207 and 208:
Table 15. 19 Physical examination-C
Page 209 and 210:
Table 15. 20 Physical examination -
Page 211 and 212:
Table 15. 21 Listing of subjects wi
Page 213 and 214:
NO. Subject ID Group Comment 54 Y03
Page 215:
Deviation type N : no ACT measureme
show all

Clinical Study Report - Calidad de Información CFR

Create successful ePaper yourself

Delete template?

Save as template?