Clinical Study Report - Calidad de Información CFR

More documents

Recommendations

Info

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 calculated. Frequency and proportion of MACE onset were summarized by MI (Myocardial infarction) and ACC/AHA classification. Chi-square test or Fisher’s exact test was performed to compare Clotinab and ReoPro ® . The efficacy interpretation followed the decision rule below. Case A1. PP population If nine or fewer patients among seventy six subjects treated with Clotinab experience MACE, then the MACE onset rate is estimated to be below 20% and Clotinab is considered to be effective. Case A2. ITT population If ten or fewer patients among eighty four subjects treated with Clotinab experience MACE, then the MACE onset rate is estimated to be below 20% and Clotinab is considered to be effective. Case A3. FAS population If ten or fewer patients among eighty three subjects treated with Clotinab experience MACE, then the MACE onset rate is estimated to be below 20% and Clotinab is considered to be effective. Case B If the number of MACE patients is over the defined number in each population, efficacy of Clotinab is evaluated after adjusting the critical value based on the MACE onset rate in ReoPro ® . Secondary efficacy endpoint -New change in electrocardiogram that indicates the status of ischemia Frequency, proportion and 95% exact C.I. of new changes from pre-administration to post-administration in electrocardiogram (yes/no) were presented. Fisher’s exact test was performed to find the differences between two groups. Frequency was CSR_Clotinab_II 8 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 Efficacy results presented and McNemar’s test was applied to determine if the changes in electrocardiogram from pre- to post-administration is significant. Safety endpoints – Bleeding, thrombocytopenia, change in Hb/Hct, adverse event Frequency, proportion and 95% exact C.I. for each endpoint were presented. The primary efficacy endpoint is the onset of MACE within 30(+7) days from the study drug administration following the PCI procedure. The MACE includes the death related to heart disease, the recurrence of myocardial infarction (MI) and the emergency revascularization. No patient among 84 patients in the Clotinab group experienced the primary efficacy measure, the MACE. Whether we analyze the PP population, ITT population, or FAS population, the same conclusion is reached. Clotinab is effecitve in preventing the MACE event. The upper bound of 95% confidence interval is all below 5% regardless of the analysis population, indicating that the MACE rate among patients undergoing the PCI procedure will be less than 5% if also treated with Clotinab. Only one Clotinab patient experienced a new change in electrocardiogram. The rate of the status of ischemia indicated by electrocardiogram in the Clotinab patients at day 30(+7) dropped significantly by about 17-21%, depending on the analysis population, from the baseline. No Clotinab patient experienced major bleeding event. We can conclude that Clotinab is effective and safe in preventing the MACE in patients undergoing the PCI procedure. Two patient among 40 patients in the ReoPro ® group experienced the MACE. The upper bound of 95% confidence interval is about 16.9-18.7% depending on the analysis population. This indicates that less than 20% of the patients undergoing the PCI proceudre will experience the MACE if also treated with ReoPro ® . Only one patient experienced a new change in electrocardiogram. The rate of the status of ischemia indicated by electrocardiogram in the ReoPro ® group at dqy 30(+7) CSR_Clotinab_II 9 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: Sponsor: ISU ABXIS Co.,Ltd Study nu
Page 11 and 12: 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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?