protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02125461 | 13.3.2 | Paternal exposure | 13.3.2 Paternal exposure Information on the pregnancy of a patient's partner must be obtained directly from the patient's partner. Therefore, prior to obtaining information on the pregnancy, the Investigator must obtain the consent of the patient's partner. Male patients should refrain from fathering a child or donatin... | [] |
NCT02125461 | 14 | LIST OF REFERENCES | 14. LIST OF REFERENCES
Aaronson et al 1993 Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993 Mar 3;85(5):365-76.
Asa... | [
"Aaronson et al 1993",
"Asami et al 2013",
"Bayman et al 2014",
"Berger et al 2008",
"Bergman et al 1994",
"Berry et al 1991",
"Blank et al 2006",
"Brahmer et al 2010",
"Brahmer et al 2012",
"Brahmer et al 2013",
"Burman et al 2009",
"Butts et al 2014",
"Cockcroft and Gault 1976",
"Collett... |
NCT02125461 | A | GUIDE TO INTERPRETING THE CAUSALITY QUESTION | A GUIDE TO INTERPRETING THE CAUSALITY QUESTION 7KHIROORZLQJIDFWRUVVKRXOGEHFRQVLGHUHGZKHQGHFLGLQJLIWKHUHLVD³UHDVRQDEOH SRVVLELOLW\´WKDWDQ\$(PD\KDYHEHHQFDXVHGE\WKHGUXJ - x 7LPH&RXUVH([SRVXUHWRVXVSHFWGUXJ+DVWKHVXEMHFWDFWXDOO\UHFHLYHGWKH VXVSHFWGUXJ"'LGWKH\$(RFFXULQDUHDVRQDEOHWHPSRUDOUHODWLRQVKLSWRWKH DGPLQLVWUDWLRQRIWKHVX... | [
"LABELLING AND SHIPMENT OF BIOHAZARD SAMPLES",
"LIST OF ABBREVIATIONS AND DEFINITION OF TERMS",
"1. BACKGROUND AND RATIONALE",
"2. GENETIC RESEARCH OBJECTIVES",
"3. GENETIC RESEARCH PLAN AND PROCEDURES",
"3.1 Selection of genetic research population",
"3.1.1 Study selection record",
"3.1.2 Inclusion c... |
NCT02153073 | 1.0 | Background | 1.0 Background Lotriga Granular Capsules (the "Drug") is an oral capsule formulation containing the active ingredient omega-3 fatty acid ethyl esters (principally EPA-E and DHA-E). The Drug differs from general marine oil products, such as supplements, in containing a high concentration of omega-3 fatty acid ethyl este... | [] |
NCT02153073 | 2.0 | Objective | 2.0 Objective To evaluate the safety and efficacy of long-term use of the Drug in patients with hyperlipidemia in a routine clinical setting. | [] |
NCT02153073 | 3.0 | Target Sample Size and Rationale for Sample Size Setting | 3.0 Target Sample Size and Rationale for Sample Size Setting | [] |
NCT02153073 | 3.1 | Target Sample Size | 3.1 Target Sample Size 3,000 patients | [] |
NCT02153073 | 3.2 | Rationale for Sample Size Setting | 3.2 Rationale for Sample Size Setting Bleeding-related events are set as a priority survey item for the Drug. As postmarketing surveillance of EPA products in antihyperlipidemic therapy has reported that the incidence of bleeding-related ADRs was 0.4% and that the percentage of anticoagulant and antiplatelet concomitan... | [] |
NCT02153073 | 4.0 | Study Population | 4.0 Study Population Patients with hyperlipidemia will be eligible for this study; however, those who meet the following exclusion criteria were excluded from the study.
Exclusion criteria: - (1) Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptys... | [
"Exclusion criteria:"
] |
NCT02153073 | 5.0 | Dosage and Administration for Study Population | 5.0 Dosage and Administration for Study Population The usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. However, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the patient's triglyceride level. | [] |
NCT02153073 | 6.0 | Number of Study Sites by Clinical Department About 200 sites (clinical departments not specified) | 6.0 Number of Study Sites by Clinical Department About 200 sites (clinical departments not specified) | [] |
NCT02153073 | 7.0 | Study Method | 7.0 Study Method | [] |
NCT02153073 | 7.1 | Observation Period | 7.1 Observation Period 12 months | [] |
NCT02153073 | 7.2 | Request and Contract to Study Sites | 7.2 Request and Contract to Study Sites The Study will be requested and contracted using a web-based electronic data collection system . Takeda Pharmaceutical's staffs (hereinafter "Takeda staffs") will adequately explain to investigators about the purpose and description of the Study, 's operating procedure, electroni... | [] |
NCT02153073 | 7.3 | Patient Enrollment Method | 7.3 Patient Enrollment Method Patients will be "centrally" enrolled using . The investigator will enter into patient enrollment information (see Section 9.1) of patients for whom the Drug has been prescribed since the start date of the period of contract with the study site, within 14 days after the prescription date o... | [] |
NCT02153073 | 7.4 | Data Entry and Electronic Signature to Electronic Case Report Form (eCRF) | 7.4 Data Entry and Electronic Signature to Electronic Case Report Form (eCRF) The investigator will enter patient data including demographics and treatment into and electronically sign the eCRF in 12 months after the start of treatment with the Drug (baseline). CCI If a patient discontinues the treatment with the Drug ... | [] |
NCT02153073 | 7.5 | Action Taken at Onset of Serious Adverse Event | 7.5 Action Taken at Onset of Serious Adverse Event The investigator will immediately contact the Takeda staff if a serious AE occurs during the observation period. The investigator will also separately provide detailed information thereof upon request, if any, from the Takeda staff. | [] |
NCT02153073 | 8.0 | Expected Duration of Study | 8.0 Expected Duration of Study Surveillance period: May 2013 to May 31, 2017 Patient enrollment period: May 2013 to May 31, 2015\ | [] |
NCT02153073 | 9.0 | Survey Items | 9.0 Survey Items The investigator will enter the information of the following items into . The schedule for the Study is provided in the Appendix. CCI | [] |
NCT02153073 | 9.1 | Patient Enrollment | 9.1 Patient Enrollment 1) Survey items Prescription date of the Date, patient ID number, patient initials, sex, birth date, determination with inclusion criteria, and determination with exclusion criteria 2) Survey timing The time of patient enrollment | [] |
NCT02153073 | 9.2 | Patient Demographics | 9.2 Patient Demographics 1) Survey items Height, weight, time of hyperlipidemia diagnosis, treatment category, menopausal status (only for female), complications (presence or absence and details), medical history (presence or absence and details), hypersensitivity disposition (presence or absence and details), drinking... | [] |
NCT02153073 | 9.3 | Treatment Information | 9.3 Treatment Information 1) Survey items \ Enrollment may be closed before the end of the enrollment period if the total number of patients enrolled in the Study reaches the target sample size. Administration of the Drug (daily dose, treatment duration, and status of completion of treatment with the Drug), administrat... | [] |
NCT02153073 | 9.4 | Testing/Observation Items | 9.4 Testing/Observation Items 1) Survey items Triglyceride (TG), total cholesterol (TC), LDL cholesterol\ (LDL-C), HDL cholesterol (HDL-C), VLDL cholesterol (VLDL-C), Apo-AI, Apo-B, Apo-CIII, lipoprotein (a), remnant lipoprotein cholesterol (RLP-C), fasting blood glucose (FBG), HbA1c - \: When tested by direct measurem... | [] |
NCT02153073 | 9.5 | Other Observation Items | 9.5 Other Observation Items 1) Survey items Pregnancy status If the patient is found to be pregnant during the observation period, the investigator will report the Takeda staff. The investigator will, upon request from the Takeda staff, use a sheet for pregnant women to provide detailed information (including informati... | [] |
NCT02153073 | 9.6 | Adverse Events (AEs) | 9.6 Adverse Events (AEs) 1) Survey items Presence or absence of AE (see Table 1), AE name, date of onset, seriousness and reason for seriousness (see Table 2), action taken to the Drug, date of determination of outcome, outcome, and causal relationship to the Drug\ (see Table 3) If the outcome is not resolved or unknow... | [
"Table 1 Definition of Adverse Event",
"Table 2 Seriousness Criteria",
"Takeda Medically Significant AE List"
] |
NCT02153073 | 10.0 | Analysis Items and Method | 10.0 Analysis Items and Method | [] |
NCT02153073 | 10.1 | Patient Disposition Items | 10.1 Patient Disposition Items Compile information including the number of enrolled patients, number of patients with eCRFs collected, numbers of safety- and efficacy-evaluable patients, and the number of patients excluded from analysis and reasons for exclusion. | [] |
NCT02153073 | 10.2 | Patient Demographics | 10.2 Patient Demographics Compile patient demographic information including sex, age, hypersensitivity disposition, and complications. | [] |
NCT02153073 | 10.3 | Treatment Details | 10.3 Treatment Details Compile information on administration of the Drug and of concomitant medications. | [] |
NCT02153073 | 10.4 | Safety Items | 10.4 Safety Items Compile the following regarding the safety-evaluable population. AEs, coded using MedDRA, will be summarized by preferred term (PT) and by system organ class (SOC). | [] |
NCT02153073 | 10.4.1 | Onset Status of Adverse Events | 10.4.1 Onset Status of Adverse Events Compile the incidence of AEs occurring during the observation period, in terms of, e.g., causal relationship with the Drug, type, seriousness. Note that bleeding-related events should be separately compiled because such events are set as a priority survey item. | [] |
NCT02153073 | 10.4.2 | Factors Likely to Affect Safety | 10.4.2 Factors Likely to Affect Safety Compile the incidence of ADRs occurring during the observation period, by stratification variables: patient baseline characteristics (sex, age, presence or absence of renal dysfunction, presence or absence of hepatic dysfunction, etc.) and treatment regimen (administration of the ... | [] |
NCT02153073 | 10.5 | Efficacy Items | 10.5 Efficacy Items Compile the following regarding the efficacy-evaluable population. 10.5.1 Changes in Lipid Parameters: TG, TC, LDL-C, HDL-C, Non-HDL-C, etc. Tabulate observed values and changes (observed value at each observational timepoint after baseline minus observed value at baseline) at each observational tim... | [] |
NCT02153073 | 10.5.2 | Factors Likely to Affect Efficacy | 10.5.2 Factors Likely to Affect Efficacy Compile TG values by stratification variables: patient baseline characteristics (sex and age) and treatment regimen (administration of the Drug, administration of concomitant medications, etc.). | [] |
NCT02153073 | 11.0 | Organizational Structure for Conducting the Study | 11.0 Organizational Structure for Conducting the Study Study Chair Takeda Pharmaceutical Co., Ltd. Post Marketing Surveillance Manager 12.0 Service Contractor's Name and Address and Scope of Contract Work (1) Scope of work: Data management (2) PPD PPD Scope of work: Data management and statistical analysis (3) PPD Scop... | [] |
NCT02153073 | 13.0 | Other Necessary Items | 13.0 Other Necessary Items | [] |
NCT02153073 | 13.1 | Protocol Revision | 13.1 Protocol Revision During the surveillance period, keep track of, e.g., the progress of the Study, the onset of unexpected ADRs or serious ADRs based on the precautions, presence or absence of increased incidence of specified ADRs, the appropriateness of survey items. If needed, review and revise this protocol. If ... | [] |
NCT02153073 | 13.2 | Action Taken in Case of Problem or Question | 13.2 Action Taken in Case of Problem or Question If any problem is found in the safety or efficacy of the Drug, carefully review the data and examine what needs to be done. | | Survey and Data Entry Timing | | | Observation Period | | | | | | | |--------------------------|-----------------------------------------------... | [
"Special Drug Use Surveillance Protocol Lotriga Granular Capsules Special Drug Use Surveillance",
"1.0 Background",
"2.0 Objective",
"3.0 Target Sample Size and Rationale for Sample Size Setting",
"3.1 Target Sample Size",
"3.2 Rationale for Sample Size Setting",
"4.0 Study Population",
"Exclusion cri... |
NCT02153073 | 13.0 | Other Necessary Items | 13.0 Other Necessary Items | [] |
NCT02153073 | 13.1 | Protocol Revision | 13.1 Protocol Revision During the surveillance period, keep track of, e.g., the progress of the Study, the onset of unexpected ADRs or serious ADRs based on the precautions, presence or absence of increased incidence of specified ADRs, the appropriateness of survey items. If needed, review and revise this protocol. If ... | [] |
NCT02153073 | 13.2 | Action Taken in Case of Problem or Question | 13.2 Action Taken in Case of Problem or Question If any problem is found in the safety or efficacy of the Drug, carefully review the data and examine what needs to be done. | | Survey and Data Entry Timing | | | Observation Period | | | | | | | |--------------------------|-----------------------------------------------... | [
"Special Drug Use Surveillance Protocol Lotriga Granular Capsules Special Drug Use Surveillance",
"1.0 Background",
"2.0 Objective",
"3.0 Target Sample Size and Rationale for Sample Size Setting",
"3.1 Target Sample Size",
"3.2 Rationale for Sample Size Setting",
"4.0 Study Population",
"Exclusion cri... |
NCT02153073 | 13.0 | Other Necessary Items | 13.0 Other Necessary Items | [] |
NCT02153073 | 13.1 | Protocol Revision | 13.1 Protocol Revision During the surveillance period, keep track of, e.g., the progress of the Study, the onset of unexpected ADRs or serious ADRs based on the precautions, presence or absence of increased incidence of specified ADRs, the appropriateness of survey items. If needed, review and revise this protocol. If ... | [] |
NCT02153073 | 13.2 | Action Taken in Case of Problem or Question | 13.2 Action Taken in Case of Problem or Question If any problem is found in the safety or efficacy of the Drug, carefully review the data and examine what needs to be done. | Survey and Data Entry TimingenrollmeBaselinePatientMonth3ntSurvey Item | Month6 | Observation PeriodMonth9 | | | |-------------------------------... | [
"Special Drug Use Surveillance Protocol Lotriga Granular Capsules Special Drug Use Surveillance",
"1.0 Background",
"2.0 Objective",
"3.0 Target Sample Size and Rationale for Sample Size Setting",
"3.1 Target Sample Size",
"3.2 Rationale for Sample Size Setting",
"4.0 Study Population",
"Exclusion cri... |
NCT02153073 | 13.0 | Other Necessary Items | 13.0 Other Necessary Items | [] |
NCT02153073 | 13.1 | Protocol Revision | 13.1 Protocol Revision During the surveillance period, keep track of, e.g., the progress of the Study, the onset of unexpected ADRs or serious ADRs based on the precautions, presence or absence of increased incidence of specified ADRs, the appropriateness of survey items. If needed, review and revise this protocol. If ... | [] |
NCT02153073 | 13.2 | Action Taken in Case of Problem or Question | 13.2 Action Taken in Case of Problem or Question If any problem is found in the safety or efficacy of the Drug, carefully review the data and examine what needs to be done. | Survey and Data Entry TimingenrollmeBaselinePatientMonth3ntSurvey Item | Month6 | Observation PeriodMonth9 | | | |-------------------------------... | [
"Special Drug Use Surveillance Protocol Lotriga Granular Capsules Special Drug Use Surveillance",
"1.0 Background",
"2.0 Objective",
"3.0 Target Sample Size and Rationale for Sample Size Setting",
"3.1 Target Sample Size",
"3.2 Rationale for Sample Size Setting",
"4.0 Study Population",
"Exclusion cri... |
NCT02153073 | 13.0 | Other Necessary Items | 13.0 Other Necessary Items | [] |
NCT02153073 | 13.1 | Protocol Revision | 13.1 Protocol Revision During the surveillance period, keep track of, e.g., the progress of the Study, the onset of unexpected ADRs or serious ADRs based on the precautions, presence or absence of increased incidence of specified ADRs, the appropriateness of survey items. If needed, review and revise this protocol. If ... | [] |
NCT02153073 | 13.2 | Action Taken in Case of Problem or Question | 13.2 Action Taken in Case of Problem or Question If any problem is found in the safety or efficacy of the Drug, carefully review the data and examine what needs to be done. | | Survey and Data Entry Timing | Observation Period | | | | | | | |--------------------------|---------------------------------------------------... | [
"Special Drug Use Surveillance Protocol Lotriga Granular Capsules Special Drug Use Surveillance",
"1.0 Background",
"2.0 Objective",
"3.0 Target Sample Size and Rationale for Sample Size Setting",
"3.1 Target Sample Size",
"3.2 Rationale for Sample Size Setting",
"4.0 Study Population",
"Exclusion cri... |
NCT02153073 | 13.0 | Other Necessary Items | 13.0 Other Necessary Items | [] |
NCT02153073 | 13.1 | Protocol Revision | 13.1 Protocol Revision During the surveillance period, keep track of, e.g., the progress of the Study, the onset of unexpected ADRs or serious ADRs based on the precautions, presence or absence of increased incidence of specified ADRs, the appropriateness of survey items. If needed, review and revise this protocol. If ... | [] |
NCT02153073 | 13.2 | Action Taken in Case of Problem or Question | 13.2 Action Taken in Case of Problem or Question If any problem is found in the safety or efficacy of the Drug, carefully review the data and examine what needs to be done. | | Survey and Data Entry Timing | Observation Period | | | | | | | |--------------------------|---------------------------------------------------... | [
"Special Drug Use Surveillance Protocol Lotriga Granular Capsules Special Drug Use Surveillance",
"1.0 Background",
"2.0 Objective",
"3.0 Target Sample Size and Rationale for Sample Size Setting",
"3.1 Target Sample Size",
"3.2 Rationale for Sample Size Setting",
"4.0 Study Population",
"Exclusion cri... |
NCT02153073 | 13.0 | Other Necessary Items | 13.0 Other Necessary Items | [] |
NCT02153073 | 13.1 | Protocol Revision | 13.1 Protocol Revision During the surveillance period, keep track of, e.g., the progress of the Study, the onset of unexpected ADRs or serious ADRs based on the precautions, presence or absence of increased incidence of specified ADRs, the appropriateness of survey items. If needed, review and revise this protocol. If ... | [] |
NCT02153073 | 13.2 | Action Taken in Case of Problem or Question | 13.2 Action Taken in Case of Problem or Question If any problem is found in the safety or efficacy of the Drug, carefully review the data and examine what needs to be done. | Survey and Data Entry Timing | | Observation Period | | | | | | | |--------------------------------|---------------------------------------------... | [] |
NCT02161406 | A | phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial | A phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial
ASSET [IM101-344] Principal Investigator: Dinesh Khanna, MD, MS Associate Professor of Medicine Director, Scleroderma Program University of Michigan Rh... | [
"ASSET",
"PROTOCOL SYNOPSIS",
"1 INTRODUCTION",
"1.1 Summary of Results of Investigational Program",
"1.1.1 Pharmacology of Abatacept",
"1.1.2 Human Pharmacokinetics of Abatacept",
"1.1.3 Clinical Safety with Abatacept SC Formulation",
"1.1.4 Drug-Related Adverse Events",
"Injection Site Reactions i... |
NCT02164513 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT02164513 | 1.1 | Background | 1.1. Background Chronic obstructive pulmonary disease (COPD) is a progressive disease characterised by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. In 2011, the Global Initiative for Chronic Obstruct... | [] |
NCT02164513 | 1.2 | Rationale | 1.2. Rationale COPD guidelines advocate the use of one or more long-acting bronchodilators (LAMA or LABA) in addition to inhaled corticosteroids (ICS) as second line therapy for the most advanced patients with significant symptoms and a high risk of exacerbations. Regular treatment with ICS has been reported to improve... | [] |
NCT02164513 | 1.3 | Benefit:Risk Assessment | 1.3. Benefit:Risk Assessment Summaries of findings from both clinical and non-clinical studies conducted with GSK2834425 can be found in the Investigator's Brochure. The following section outlines the risk assessment and mitigation strategy for this protocol: | [] |
NCT02164513 | 1.3.1 | Risk Assessment | 1.3.1. Risk Assessment | Potential Risk of | | Mitigation Strategy | |----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------... | [] |
NCT02164513 | 1.3.2 | Benefit Assessment | 1.3.2. Benefit Assessment In a disease where polypharmacy is common, the 'closed' triple, once-daily combination of FF/UMEC/VI (100mcg/62.5mcg/25mcg), has the potential to optimise bronchodilator therapy, improve patient adherence to therapy and, as a result, improve overall disease management in COPD patients. Publish... | [] |
NCT02164513 | 1.3.3 | Overall Benefit: Risk Conclusion | 1.3.3. Overall Benefit: Risk Conclusion Current risks that have been identified for the FF/UMEC/VI (100mcg/62.5 mcg/25mcg) combination are based on the known pharmacology of the individual components FF, UMEC and VI. These include key risks of pneumonia and bone disorders/fractures from ICS-containing combinations, and... | [] |
NCT02164513 | 2 | OBJECTIVES | 2. OBJECTIVES
Primary Objective To evaluate the efficacy of FF/UMEC/VI to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD.
Secondary Objectives - To evaluate the long term safety and other efficacy assessments of FF/UMEC/VI compared with... | [
"Primary Objective",
"Secondary Objectives",
"Other Objectives"
] |
NCT02164513 | 3 | INVESTIGATIONAL PLAN | 3. INVESTIGATIONAL PLAN | [] |
NCT02164513 | 3.1 | Study Design | 3.1. Study Design Protocol waivers or exemptions are not allowed with the exception of immediate safety concerns. Therefore, adherence to the study design requirements, including those specified in the Time and Events Table, are essential and required for study conduct. Supplementary study conduct information not manda... | [] |
NCT02164513 | 3.2 | Discussion of Design | 3.2. Discussion of Design This study will use a multicenter, randomized, double-blind, parallel-group design. This is a well-established design to evaluate the efficacy and safety of an investigational drug. A placebo arm is not included because the comparisons of primary interest are FF/UMEC/VI versus FF/VI and versus... | [] |
NCT02164513 | 4 | SUBJECT SELECTION AND WITHDRAWAL CRITERIA | 4. SUBJECT SELECTION AND WITHDRAWAL CRITERIA | [] |
NCT02164513 | 4.1 | Number of Subjects | 4.1. Number of Subjects Approximately 16,000 subjects will be screened in order to randomize approximately 10,000 subjects. All randomized subjects are considered evaluable. Approximately 1,200 centers globally will be required to recruit the study. | [] |
NCT02164513 | 4.2 | Inclusion Criteria | 4.2. Inclusion Criteria Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the IB/IB supplements. Deviations from inclusion criteria are no... | [
"OR",
"OR"
] |
NCT02164513 | 11 | Liver function tests: | 11. Liver function tests: - alanine aminotransferase (ALT) 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - 12. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
4.3. Exclusio... | [
"4.3. Exclusion Criteria",
"4.4. Investigational Product (IP) Discontinuation Criteria",
"4.4.1. Protocol defined stopping IP criteria",
"4.4.2. Permanent Discontinuation of Investigational Product (IP)",
"4.4.3. IP Discontinuation Study Assessments",
"4.4.4. Reasons for Permanent Discontinuation of IP",
... |
NCT02164513 | 11 | APPENDICES | 11. APPENDICES | [] |
NCT02164513 | 11.1 | Appendix 1: Genetic research | 11.1. Appendix 1: Genetic research
Genetic Research Objectives and Analyses The objectives of the genetic research are to investigate the relationship between genetic variants and: - Response to medicine, including Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI); Umeclidinium (UMEC)/Vilanterol (VI); and F... | [
"Genetic Research Objectives and Analyses",
"Study Population",
"Study Assessments and Procedures",
"Informed Consent",
"Subject Withdrawal from Study",
"Screen and Baseline Failures",
"Provision of Study Results and Confidentiality of Subject's Data"
] |
NCT02164513 | 11.2 | Appendix 2: Country Specific Requirements | 11.2. Appendix 2: Country Specific Requirements In China only, Serious AEs will be recorded from the time the consent form is signed until the 7-day safety follow-up visit/telephone contact has been completed, or until Visit 7(telephone contact) for subjects who have discontinued IP but continue in the study. No study ... | [] |
NCT02164513 | 11.2.1 | China-specific sub-study: Collection of unit-cost data for healthcare utilization among COPD subjects recruited to Study CTT116855 in China | 11.2.1. China-specific sub-study: Collection of unit-cost data for healthcare utilization among COPD subjects recruited to Study CTT116855 in China | [] |
NCT02164513 | 11.2.1.1 | Introduction | 11.2.1.1. Introduction Globally, health economic (HE) evidence is becoming more and more critical to ensure that the value of new medicines is demonstrated and that patients with unmet need have access to these new medicines. In China, recent high-profile meetings, including Healthcare State Council meetings have highl... | [] |
NCT02164513 | 11.2.1.2 | Objective | 11.2.1.2. Objective To collect unit cost data (direct and indirect) for healthcare utilization among COPD subjects recruited to Study CTT116855 in China | [] |
NCT02164513 | 11.2.1.3 | Investigational Plan | 11.2.1.3. Investigational Plan This is a China-specific sub-study to collect direct and indirect unit cost data for healthcare utilization in subjects who have consented and been randomized to study CTT116855 (Core Study), "A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the effica... | [] |
NCT02164513 | 11.2.1.4 | Subject Selection and Withdrawal Criteria | 11.2.1.4. Subject Selection and Withdrawal Criteria | [] |
NCT02164513 | 11.2.1.4.1 | Inclusion Criteria | 11.2.1.4.1. Inclusion Criteria Subjects eligible for enrolment in the study must meet all of the following criteria: - 1. Subjects in China, who have provided written informed consent and have been randomized to study CTT116855 (Core Study). - 2. Separate Informed Consent for China-specific sub-study: A signed and date... | [] |
NCT02164513 | 11.2.1.4.2 | Exclusion Criteria | 11.2.1.4.2. Exclusion Criteria There are no exclusion criteria to this sub-study. [1,](#page-95-1) [2](#page-95-3) Both of these are mutually exclusive and comprehensive. Therefore the sums of 1 and 2 should equate to the total unit cost of healthcare resource used | [] |
NCT02164513 | 11.2.1.4.3 | Sub-study Withdrawal Criteria | 11.2.1.4.3. Sub-study Withdrawal Criteria Every effort should be made by the Investigator to keep the subject in this sub-study. However a subject may voluntarily withdraw from participation in this sub-study at any time. In the event that a subject withdraws consent from this sub-study, they will be encouraged to cont... | [] |
NCT02164513 | 11.3 | Appendix 3: Liver Chemistry Stopping and Follow-up Criteria | 11.3. Appendix 3: Liver Chemistry Stopping and Follow-up Criteria  | [] |
NCT02164513 | 11.4 | Appendix 4: Laboratory Assessments | 11.4. Appendix 4: Laboratory Assessments Refer to the Time and Events Table for information regarding the timing of laboratory tests. | CHEMISTRY | HEMATOLOGY | OTHER | |--------------------------------------------|-----------------------------------|------------------------------| | Albumin | Hemoglobin | Hepatitis B ... | [] |
NCT02164513 | 11.5 | Appendix 5: Protocol Changes | 11.5. Appendix 5: Protocol Changes
Revision History | 2013N17691300 | 2014-MAR-17 | Original | |----------------|-------------|----------------------------------| | 2013N17691301 | 2014-MAR-31 | Amendment No.: 01 | | 2013N17691302 | 2014-APR-10 | Amendment No.:02 | | 2013N17691303 | 2014-DEC-05 | Amendment NO.:03 (Chi... | [
"Revision History"
] |
NCT02164513 | 11.5.1 | Amendment 1 | 11.5.1. Amendment 1 Amendment 01 applies to all countries and study centers participating in the CTT116855 study. Amendment 01 purpose is to clarify verbiage pertaining to approval status of products in the protocol and to also clarify information concerning hematology collection and to correct minor errors in the Time... | [] |
NCT02164513 | 11.5.2 | Amendment 2 | 11.5.2. Amendment 2 Amendment 02 applies to all countries and study centers participating in the CTT116855 study. Amendment 02 purpose was to add post-bronchodilator FEV1 to each visit and include this as an Other Efficacy Endpoint. A mortality endpoint was also added as an "Other Efficacy Endpoint". Other changes incl... | [] |
NCT02164513 | 11.5.3 | Amendment 3 | 11.5.3. Amendment 3 This country specific protocol amendment 03 applies to all study centers in China. Reason for protocol amendment 03: This amendment is written to meet the requirements of the China Good Clinical Practice (GCP) of Pharmaceutical Products. This amendment is specific to China that Serious AEs will be r... | [
"Section 6. STUDY ASSESSMENTS AND PROCEDURES, Table 4 Time and Events",
"Original text:",
"Amended text:",
"NOTE:",
"Reason for change:",
"Section 6.3.9. Time Period and Frequency of Detecting AEs and SAEs",
"Additional text:",
"Reason for change:",
"Section 11.2 Appendix 2: Country Specific Require... |
NCT02164513 | 11.5.4 | Amendment 4 | 11.5.4. Amendment 4 This country specific protocol amendment applies to all study centers in China. Amendment 04 purpose was to: Clarify that no study centers in China will participate in genetic research in this study. The reason for change is that due to a new interpretation of Chinese regulations, the main study can... | [
"Section 6. STUDY ASSESSMENTS AND PROCEDURES, Table 4 Time and Events",
"Original text:",
"Amended text:",
"Section 6. 6. Genetic Research",
"Original text:",
"Amended text:",
"Section 11.1. Appendix 1: Genetic Research",
"Original text:",
"Study Population",
"Amended text:",
"Study Population",... |
NCT02164513 | 11.2.1 | China-specific sub-study: Collection of unit-cost data for healthcare utilization among COPD subjects recruited to Study CTT116855 in China | 11.2.1 China-specific sub-study: Collection of unit-cost data for healthcare utilization among COPD subjects recruited to Study CTT116855 in China | [] |
NCT02164513 | 11.2.1.1 | Introduction | 11.2.1.1 Introduction Globally, health economic (HE) evidence is becoming more and more critical to ensure that the value of new medicines is demonstrated and that patients with unmet need have access to these new medicines. In China, recent high-profile meetings, including Healthcare State Council meetings have highli... | [] |
NCT02164513 | 11.2.1.2 | Objective | 11.2.1.2 Objective To collect unit cost data (direct and indirect) for healthcare utilization among COPD subjects recruited to Study CTT116855 in China | [] |
NCT02164513 | 11.2.1.3 | Investigational Plan | 11.2.1.3 Investigational Plan This is a China-specific sub-study to collect direct and indirect unit cost data for healthcare utilization in subjects who have consented and been randomized to study CTT116855 (Core Study), "A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the efficac... | [] |
NCT02164513 | 11.2.1.4 | Subject Selection and Withdrawal Criteria | 11.2.1.4 Subject Selection and Withdrawal Criteria | [] |
NCT02164513 | 11.2.1.4.1 | Inclusion Criteria | 11.2.1.4.1 Inclusion Criteria Subjects eligible for enrolment in the study must meet all of the following criteria: - 1. Subjects in China, who have provided written informed consent and have been randomized to study CTT116855 (Core Study). - 2. Separate Informed Consent for China-specific sub-study: A signed and dated... | [] |
NCT02164513 | 11.2.1.4.2 | Exclusion Criteria | 11.2.1.4.2 Exclusion Criteria There are no exclusion criteria to this sub-study. | [] |
NCT02164513 | 11.2.1.4.3 | Sub-study Withdrawal Criteria | 11.2.1.4.3 Sub-study Withdrawal Criteria Every effort should be made by the Investigator to keep the subject in this sub-study. However a subject may voluntarily withdraw from participation in this sub-study at any time. 116 1, 2 Both of these are mutually exclusive and comprehensive. Therefore the sums of 1 and 2 shou... | [] |
NCT02164513 | 11.5.5 | Amendment 5 | 11.5.5. Amendment 5 Amendment 05 applies to all countries and study centers participating in the CTT116855 study. Amendment 05 purpose was to simplify the statistical hierarchy for the analysis of secondary endpoints. In addition, there are minor changes to the definitions of the Analysis populations, changes in model ... | [
"Original Figure 2 and text:",
"Amended Figure 2 and text:"
] |
NCT02287233 | 1.0 | Title Page | 1.0 Title Page
Clinical Study Protocol M14-387 A Phase 1/2 Study of Venetoclax in Combination with Low-Dose Cytarabine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy
Incorporating Administrative Change 1... | [
"Clinical Study Protocol M14-387",
"Incorporating Administrative Change 1 and Amendments 1, 2, 3, 4, 5, 6 and 7",
"Confidential Information"
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.