Clinical Study Report - Calidad de Información CFR

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events whose causal reations to the study drug cannot be excluded are defined as adverse drug reactions (ADRs). 2) Observation period The observation period in this study starts when the subject signs the informed consent form is signed, and ends 14 days after the last protocol visit is made. 3) Method i) The principal investigator and the sub-investigator have a responsibility for recording all AEs observed during the clnical trial. AEs should be recorded in medical terms if possible. If it is not possible, then signs or symptoms should be described based on observations by the principal investigator/sub-investigator or reported by the subject. ii) Regardless of causal relationship to the study drug, all AEs should be thoroughly monitored until they are resolved. Thair outcomes have to be evaluated. iii) Symptoms, signs, onset and termination dates, severity, actions taken, and serious AEs should be recorded in CRF. AEs’ causal relationships to the study drug have to be assessed. 4) Severity of AE i) Mild: An AE is considered mild if it does not infere with everyday activities. The subject may not recognize a mild AE. Most mild AEs do not require treatment. ii) Moderate: An AE is considered moderate if it interferes with normal daily activities. A moderate AE may make the subject uncomfortable. The subject may keep participating in the trial, but may need treatment. iii) Severe: An AE is considered severe if it prevents the subjects from normal daily activities. A severe AE makes the subject very uncomfortable. The subject may stop the treatment,. The subject may be treated for the AE or may even have to be hospitalized. 5) Causal Relationship to Study Drug i) Definite: Onset of AE is associated with administrating time of the study drug. The study drug explains onset of AE most directly than other factors. ii) Probable: Therer is association between onset of AE and administrating time of the study drug. The study drug explains onset of AE more than other factors. iii) Possible: Therer is association between onset of AE and administrating time of the study drug, however other possible factors explain onset of AE as much as the study drug does. iv) Improbable: Therer is no reasonable relationship between onset of AE and administrating time or type of the study drug, or there exists other probable cause. CSR_Clotinab_II 34 Ver. 1.0_Eng
v) None: AE occurs independently from administrating time of the study drug. vi) Unknown: Impossible to evaluate 6) Treatment for AE All the patients experiencing AEs should be monitored until AE-related symptoms disappear and observed changes are satisfactorily explained. All observed outcomes of AEs are recorded in the AE section of CRF. 9.5.2. Appropriateness of measurements The MACE occurrence rate in the high-risk patient group is commonly used as an efficacy endpoint(variable) and well-established in the clinical trial of abxicimab. 9.5.3. Primary efficacy variable The primary efficacy endpoints is the onset of major adverse cardiac event (MACE) within 30 (+7) days from the study drug administration following the PCI procedure. 9.6. Data quality assurance Clinical laboratory tests and electrocardiogram readings were carried at participating medical centers, not at a central laboratory. All centers were certified by the quality control program of Korea Society of Clinical Pathologists. Investigational products, protocol, monitoring procedures and others were reviewed and discussed at the investigators’ meeting before activating the clinical trial. Also , at the initiation meeting of each institution, detailed information about the protocol, CRF, ICH-GCP was provided to the involved staff. The Sponsor supplied case report form(CRF)s to clinical trial centers. A copy would be kept at the cetner, and the original was sent to the sponsor. The clinical trial data were recorded in the CRF. All the records were written with a black ball point pen. When correction was needed, a single line was drawn, correction was made without erasing or whiting-out the record, and investigator’s signature and date of correction were entered. Investigators verified and signed CRF entries. CRF entries were verified against CSR_Clotinab_II 35 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: 9.5.1.2. Safety measurement assesse
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
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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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