Clinical Study Report - Calidad de Información CFR

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source data document, If there were any discrepancies, they were noted on the CRF, and investigators took corrective actions. All the medical records were made avaible for review and clarification.. The pharmacist was delegated IP management by the principal investigator. The pharemacit received IP, checked the quantity, and managed IP in general. IP adminstration followed the protocol and instruction. Unused IP was retrieved by Sponsor; every unused drug, used/unused vials, labels, and copies of IP management document were sent to the monitor at the end of the trial. During the trial, monitors visited study centers regularly to mointor whether the trial was following the protocol, standard operation procedures, KGCP, and related regulations and guidliens. The source document was made to monitors, auditors, and IRB. Monitors could always access the entire source documents including CRFs, copies of laboratory result, and medical test results, and verified CRF entries and signed consents against the source document. The investigator collected and recorded all the AEs. The investigator reported SAEs to IRBs and the sponsor according to the “Chapter 17. Guidelines for adverse events” of the protocol. The SAE recporting procedure is consistent with the LSK SOP and related regulations. Data were transferred into database using DMSys 4.0, SigmaSoft International, Florida USA, by two entry persons. File comparison was performed. Medical Dictionary for Drug Regulatory Affairs(MedDRA) and Drug Reference list (Anatomic Therapeutic Chemical code:ATC code) were used to perform the medical coding of adverse events and medications. Data clarification forms (DCFs) were issued to query CRF entries. Consistency between essential documents for trial master files and essential documents for investigator site files was maintained. Corrections of CRF entries were reviewed and approved by the investigators. The datebase was locked on Februaty 08 th , 2006. 9.7. Statistical methods planned in the protocol and determination of sample size CSR_Clotinab_II 36 Ver. 1.0_Eng
9.7.1. Statistical and Analytical Plans 9.7.1.1. General principle for statistical analysis 1) A one-sided significance test was applied to the primary efficacy endpoint at α = 0.05. All other significance tests was two-sided at α = 0.05. 2) The efficacy analysis was the per protocol (PP) analysis. 3) All statistical analysis was carried out by SAS ® Version 9.1, SAS institute, Cary, NC, USA. Exact confidence interval was computed by StatXact version 4.0, Cytel software corp. 4) All confidence interval was presented by 95% exact confidence interval. 9.7.1.2. Analysis of Demographic and Baseline characteristics Demographic variables (age, height, weight, sex) and baseline variables (medical history, concomitant medication) were summarized by treatment group. Descriptive statistics were produced for baseline demographic variables. Mean, standard deviation, median, and maximum and minimum were presented for continuous variables, and frequencies and proportions were generated for categorical variables. Continuous variables were compared using t-test or Wilcoxon rank sum test by treatment group. Categorical variables were compared using chi-square test or Fisher’s exact test. 9.7.1.3. Efficacy Analysis Primary efficacy endpoint and analysis (1) Primary Efficacy Endpoint The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30(+7) days from the study drug administration following the PCI procedure. The MACE included the death related to heart disease, the recurrence of myocardial infarction (MI) and the emergency revascularization. (2) Analysis methods The number and proportion of subjects experiencing the MACE were presented. The frequency, proportion and its exact 95% C.I. for subjects by MACE types were 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. CSR_Clotinab_II 37 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 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: v) None: AE occurs independently fr
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
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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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