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NCT02991144 | 12.9 | Publications | 12.9 Publications After completion of the study, the data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, t... | [] |
NCT02991144 | 13 | Study Management | 13 Study Management The administrative structure will include a DMC (Section [9.3\)](#page-80-0). | [] |
NCT02991144 | 13.1 | Monitoring | 13.1 Monitoring | [] |
NCT02991144 | 13.1.1 | Monitoring of the Study | 13.1.1 Monitoring of the Study The clinical monitor, as a representative of the sponsor, has the obligation to closely follow the progression of the study, ensuring that it is being conducted in compliance with the protocol, ICH E6(R2), all applicable local laws and regulations, and with current and applicable standard... | [] |
NCT02991144 | 13.1.2 | Inspection of Records | 13.1.2 Inspection of Records Investigators and institutions involved in the study will permit study-related monitoring, audits, IRB/IEC/IBC review, and regulatory inspections by providing direct access to all study records. In the event of either an audit or inspection, the investigator agrees to allow the sponsor, rep... | [] |
NCT02991144 | 13.2 | Management of Protocol Amendments and Deviations | 13.2 Management of Protocol Amendments and Deviations | [] |
NCT02991144 | 13.2.1 | Modification of the Protocol | 13.2.1 Modification of the Protocol Any changes in this research activity, except those necessary to remove an apparent, immediate hazard to the subject, must be reviewed and approved by the sponsor or its designee. Amendments to the protocol must be submitted in writing to the investigator's IRB/IEC/IBC for approval b... | [] |
NCT02991144 | 13.2.2 | Protocol Deviations | 13.2.2 Protocol Deviations A deviation from the protocol is a departure from the written procedures or processes. A significant deviation occurs when there is nonadherence to the protocol by the subject or investigator that results in a significant, additional risk to the subject or important change to the study design... | [] |
NCT02991144 | 13.3 | Study Termination | 13.3 Study Termination Although the sponsor has every intention of completing the study, the sponsor reserves the right to discontinue the study at any time for clinical or administrative reasons. The end of the study is defined as the date on which the last subject completes the last visit (includes follow-up visit). | [] |
NCT02991144 | 13.4 | Final Report | 13.4 Final Report Whether the study is completed or prematurely terminated, the sponsor will ensure that the clinical study reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The sponsor will also ensure that the clinical study reports in marketing a... | [
"Declaration of Investigator"
] |
NCT02991144 | 14 | Reference List | 14 Reference List Batshaw ML, Monahan PS. Treatment of urea cycle disorders. Enzyme. 1987;38(1-4):242-50. Batshaw ML, MacArthur RB, Tuchman M. Alternative pathway therapy for urea cycle disorders: twenty years later. J Pediatr. 2001;138(1 Suppl):S46-54. Batshaw ML, Tuchman M, Summar M, et al. A longitudinal study of ur... | [] |
NCT02991144 | 15 | Appendices | 15 Appendices | [] |
NCT02991144 | 15.1 | Appendix: Schedules of Events | 15.1 Appendix: Schedules of Events Protocol: 301OTC01 Table 15-1 Schedule of Events – Outpatient, Home Health Services, and Inpatient Clinic Visits | Procedure | Screening | Day 0(Baseline) | | Treatment Period: Includes Inpatient Clinic (shaded gray)Day 1and Outpatient Clinic/HHSvisits. For home visits, refer to(DTX30... | [
"Protocol: 301OTC01",
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NCT02991144 | 15.2 | Quality of Life Questionnaire | 15.2 Quality of Life Questionnaire | [] |
NCT02991144 | 15.2.1 | PROMIS Questionnaire | 15.2.1 PROMIS Questionnaire  Page 112 of 126  Page 113 of 126  Protocol: 301OTC01  | [] |
NCT02991144 | 15.3 | Protocol Amendment History and Summary of Changes | 15.3 Protocol Amendment History and Summary of Changes | [] |
NCT02991144 | 15.3.1 | Amendment 1 (dated 18 August 2016) | 15.3.1 Amendment 1 (dated 18 August 2016) The primary objective of Amendment 1 of the protocol, 301OTC01, is to address feedback received from the US Food and Drug Administration, the Medicines and Healthcare Products Regulatory Agency, and the National Institutes of Health Recombinant DNA Advisory Committee. An overvi... | [] |
NCT02991144 | 15.3.2 | Amendment 2 (dated 20 December 2016) | 15.3.2 Amendment 2 (dated 20 December 2016) The primary objective of Amendment 2 of the protocol, 301OTC01, is to address feedback received from the US Food and Drug Administration. An overview of changes includes the following: - Clarified that ammonia will be analyzed in plasma, not serum (global protocol revision). ... | [] |
NCT02991144 | 15.3.3 | Amendment 3 (dated 07 February 2017) | 15.3.3 Amendment 3 (dated 07 February 2017) The primary objective of Amendment 3 of the protocol, 301OTC01, is to address feedback received from the United Kingdom (UK) Medicines and Healthcare Products Agency (MHRA) and the Gene Therapy Advisory Committee (GTAC). An overview of changes from Amendment 2 (20 December 20... | [] |
NCT02991144 | 15.3.4 | Amendment 4 (dated 11 June 2019) | 15.3.4 Amendment 4 (dated 11 June 2019) The primary objective of Amendment 4 of the protocol, 301OTC01, is to provide details on the inclusion of the additional subjects as expansion of Cohort 3, already foreseen in the original protocol, and to add Cohort 4 (Dosing Process Optimization). Subjects in Cohort 4 will rece... | [] |
NCT02991144 | 15.3.5 | Amendment 5 (dated 25 February 2020) | 15.3.5 Amendment 5 (dated 25 February 2020) The primary objective of Amendment 5 of the protocol, 301OTC01, is to address written requests from the US Food and Drug Administration to provide more comprehensive guidance on monitoring of ammonia levels throughout the study, guidance to investigators on monitoring hyperam... | [] |
NCT02996500 | A | 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE | A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Investigational Product Number: PF-06650833 Investigational... | [
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NCT03017885 | 4 | RESPONSIBLE PARTIES | 4. RESPONSIBLE PARTIES  Contact details and the list of all investigators will be kept in a stand-alone document.    BI Study Number 1199.272 c13593217-03 Proprietary confidential information © 2021 Boehringer Ingelheim Internat... | [] |
NCT03017885 | 6 | AMENDMENTS AND UPDATES | 6. AMENDMENTS AND UPDATES | Number | Date | Section ofstudyprotocol | Amendment or update | Reason | |--------|-------------------|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Boehringer Ingelheim Page 25 of 82 Active Surveillance Protocol",
"Boehringer Ingelheim Page 27 of 82 Active Surveillance Protocol BI Study Number 1199.272 c13593217-03",
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"2. Patients who are positive for EGFR mutations or ALK rearrangements",
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NCT03017885 | 7 | MILESTONES | 7. MILESTONES | Milestone | Planned Date | |--------------------------------------------|--------------------------| | Final protocol | 26April2016 | | 1st Protocol amendment | 28September 2016 | | 2nd Protocol Amendment | 19July2018 | | 3rd Protocol Amendment | 04 Jun2021 | | Start of data collection | 30 June2017 | |... | [] |
NCT03017885 | 8 | RATIONALE AND BACKGROUND | 8. RATIONALE AND BACKGROUND Lung cancer is the leading cause of cancer deaths worldwide (R12-1150). Most patients are diagnosed with advanced or metastatic disease and although about 70% of patients initially achieve clinical remission or disease stabilisation with first-line platinum-containing therapy, nearly all hav... | [] |
NCT03017885 | 9 | RESEARCH QUESTION AND OBJECTIVES | 9. RESEARCH QUESTION AND OBJECTIVES This active surveillance aims to collect the safety data of 100 NSCLC patients with adenocarcinoma histology treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017) or as mentioned in the s... | [] |
NCT03017885 | 10.1 | STUDY DESIGN | 10.1 STUDY DESIGN 100 NSCLC patients treated with nintedanib per the Indian label will be enrolled in this active surveillance. They are classified into following groups: Group A. Patients who started treatment with nintedanib & docetaxel after 23\ January, - 2017 and have discontinued the drug at the time of participa... | [
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"The primary outcome:",
"Secondary outcome:"
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NCT03017885 | 10.7 | DATA ANALYSIS | 10.7 DATA ANALYSIS Patients" data will be gathered by the EDC system and outsourced to a CRO. Analyses will be descriptive in nature including means, medians, standard deviation and interquartile range for continuous variables, and frequencies and percentages for binary and categorical variables with the corresponding ... | [] |
NCT03017885 | 10.7.1 | Analyses of outcome events | 10.7.1 Analyses of outcome events All outcome events are based on reported AE data which will be handled according to BI standards (see the section below).
Safety In general, safety analyses will be descriptive in nature, and will be based on BI standards, and will focus on all ADRs and SAEs. AEs will be coded using t... | [
"Safety"
] |
NCT03017885 | 10.7.2 | Interim analyses | 10.7.2 Interim analyses . No interim analysis is planned for this active surveillance program; however status report will be submitted to DCGI at the end of two years from the start of marketing of the drug in India or as mentioned in the study approval letter issued by the DCGI. | [] |
NCT03017885 | 10.8 | QUALITY CONTROL | 10.8 QUALITY CONTROL All processes will be conducted according to BI PMS, NISnd and if applicable PASS SOPs. Appropriate records and documents will be stored based on all relevant SOPs and these processes are checked by internal self-check. | [] |
NCT03017885 | 10.9 | LIMITATIONS OF THE RESEARCH METHODS | 10.9 LIMITATIONS OF THE RESEARCH METHODS The scientific objective of this active surveillance program is to obtain an estimate of the occurrence of ADRs and SAEs in NSCLC patients prescribed nintedanib & docetaxel per the approved Indian label in the real world setting. For retrospective data, there may be a possibilit... | [] |
NCT03017885 | 10.10 | OTHER ASPECTS | 10.10 OTHER ASPECTS | [] |
NCT03017885 | 10.10.1 | Informed consent, data protection, study records | 10.10.1 Informed consent, data protection, study records The active surveillance will be carried out in compliance with the protocol, and the latest revision of the Declaration of Helsinki, as well as the Guidelines for Good Pharmacoepidemiological Practice (GPP) from Epidemiological Society for Pharmacoepidemiology (I... | [] |
NCT03017885 | 10.10.1.1 | Study approval, patient information, and informed consent | 10.10.1.1 Study approval, patient information, and informed consent In addition to review and approval by Drug controller general of India (DCGI), the approval of Institutional Review Board (IRB) or Ethics Committee will be sought as per the institutional procedures before the start of this active surveillance. Prior t... | [] |
NCT03017885 | 10.10.1.2 | Data quality assurance | 10.10.1.2 Data quality assurance Automatic checks at data entry will reduce the error while entering data. A quality assurance audit/inspection of this active surveillance may be conducted by the sponsor, sponsor's designees, or by IRB / IEC or by regulatory authorities. The quality assurance auditor will have access t... | [] |
NCT03017885 | 10.10.1.3 | Records | 10.10.1.3 Records Electronic data capture (EDC) will be used to gather the data. | [] |
NCT03017885 | 10.10.1.3.1 | Source documents | 10.10.1.3.1 Source documents Source documents provide evidence for the existence of the patient and substantiate the integrity of the data collected. Source documents are filed at the investigator's site. Data reported on the eCRF must be consistent with the source data or the discrepancies must be explained. The Inves... | [] |
NCT03017885 | 10.10.1.3.2 | Direct access to source data and documents | 10.10.1.3.2 Direct access to source data and documents The Investigator / institution will permit monitoring, audits, IRB/IEC review and regulatory inspection, providing direct access to all source data/documents related to this active surveillance program. CRF/eCRF and all source documents, including progress notes an... | [] |
NCT03017885 | 10.10.1.4 | Statement of confidentiality | 10.10.1.4 Statement of confidentiality Individual patient's medical information obtained as a result of this active surveillance program is considered confidential and disclosure to third parties is prohibited with the exceptions noted below. Patient confidentiality will be ensured by using patient identification code ... | [
"Boehringer Ingelheim Page 66 of 82 Active Surveillance Protocol BI Study Number 1199.272 c13593217-03"
] |
NCT03017885 | 11 | PROTECTION OF HUMAN SUBJECTS | 11. PROTECTION OF HUMAN SUBJECTS There is no need for a clinical trial insurance to ensure the well-being and rights of participants since this is an active surveillance program of the patients prescribed nintedanib per the approved Indian label in the real world setting and there is no risk of an experimental treatmen... | [] |
NCT03017885 | 12 | MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS | 12. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS | [] |
NCT03017885 | 12.1 | DEFINITIONS OF ADVERSE EVENTS | 12.1 DEFINITIONS OF ADVERSE EVENTS
Adverse event An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfav... | [
"Adverse event",
"Adverse reaction",
"Serious adverse event",
"Adverse Event of Special Interest (AESI)"
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NCT03017885 | 12.2 | ADVERSE EVENT AND SERIOUS ADVERSE EVENT COLLECTION AND REPORTING | 12.2 ADVERSE EVENT AND SERIOUS ADVERSE EVENT COLLECTION AND REPORTING The investigator shall maintain and keep detailed records of all AEs in their patient files.
Collection and Reporting of AEs The design of this active surveillance is of non-interventional nature and the study is conducted within the conditions of t... | [
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"Arguments that may suggest that there is no reasonable possibility of a causal relationship could be:",
"Intensity of adverse event",
"Pregnancy:",
"Expedited Reporting of AEs and Drug Exposure During Pregnancy",
"Information r... |
NCT03017885 | 12.3 | REPORTING TO HEALTH AUTHORITIES | 12.3 REPORTING TO HEALTH AUTHORITIES Adverse event reporting to regulatory agencies will be done by the MAH according to the local and international regulatory requirements. | [] |
NCT03017885 | 13 | PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS | 13. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS The progress reports and final reports will be submitted in Indian Periodic Safety Update Report (PSUR). A final report summarizing the results of the study and the analysis will be submitted to the Indian regulatory agency at the end of the active surveillanc... | [
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"ANNEX 3. CHILD PUGH CLASSIFICATION OF HEPATIC IMPAIRMENT",
"APPROVAL / SIGNATURE PAGE",
"Signatures (obtained electronically)",
"(Continued) Signatures (obtain... |
NCT03023826 | 1 | Protocol Synopsis | 1. Protocol Synopsis
Title of Study: Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626
Rationale: This study will explore the rate and extent of LY3202626 absorption when administered using a pilot tablet formulation, as compared to the drug-in-cap... | [
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NCT03023826 | 2 | Schedule of Activities | 2. Schedule of Activities Study Schedule Protocol I7X-MC-LLCE | | Screening | | | | Periods 1, 2, and 3 | | | | | | ET | Followupa | Comments | |--------------------------------------|--------------------------------------------------|--------------------|--------------------------------|----------|--------------------... | [
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NCT03023826 | 3.3 | Benefit/Risk Assessment | 3.3. Benefit/Risk Assessment LY3202626 has been administered to 85 healthy subjects over a range from 0.1 to 45 mg, and at steady state from 1 to 26 mg QD. LY3202626 has been administered to 2 patients with mild cognitive impairment due to AD or mild to moderate AD at a 6 mg dose level. To date, no serious adverse even... | [
"CCI"
] |
NCT03023826 | 4 | Objectives and Endpoints | 4. Objectives and Endpoints Table [LLCE.1](#page-15-1) shows the objectives and endpoints of the study.
Table LLCE.1. Objectives and Endpoints | Objectives | Endpoints | | | |------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Table LLCE.1. Objectives and Endpoints"
] |
NCT03023826 | 5 | Study Design | 5. Study Design | [] |
NCT03023826 | 5.1 | Overall Design | 5.1. Overall Design This is a single-center, open-label, single-dose, randomized, 6-sequence, 3-period, crossover study in healthy subjects. Screening will occur up to 28 days prior to the first dose of LY3202626. Subjects will be admitted to the clinical research unit (CRU) on Day -1 of each period. In each period, su... | [] |
NCT03023826 | 5.2 | Number of Participants | 5.2. Number of Participants Initially, up to approximately 24 healthy subjects may be enrolled so that approximately 20 subjects complete the study. Study completion is defined as completing all 3 study periods. If multiple subjects who are randomized withdraw before study end, up to 6 additional subjects may be enroll... | [] |
NCT03023826 | 5.3 | End of Study Definition | 5.3. End of Study Definition End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities (Section [2\)](#page-10-0) for the last subject. | [] |
NCT03023826 | 5.4 | Scientific Rationale for Study Design | 5.4. Scientific Rationale for Study Design This study uses a randomized, open-label, crossover design such that each subject acts as their own control, thus reducing variability. The open-label design with no placebo control is considered appropriate because determining the relative bioavailability of the reference cap... | [] |
NCT03023826 | 5.5 | Justification for Dose | 5.5. Justification for Dose Nonclinical data as well as safety, PK and PD data to date from the ongoing Phase 1 study in healthy subjects and patients with mild cognitive impairment (Study LLCA , see Section 3 above) support a single dose study in healthy subjects. It is anticipated that a single dose of 12 mg LY320262... | [] |
NCT03023826 | 6 | Study Population | 6. Study Population Eligibility of subjects for study enrollment will be based on the results of screening medical history, physical examination, vital signs, clinical laboratory tests, and ECG. The nature of any conditions present at the time of the physical examination and any pre-existing conditions will be document... | [] |
NCT03023826 | 6.1 | Inclusion Criteria | 6.1. Inclusion Criteria Subjects are eligible for inclusion in the study only if they meet all of the following criteria at screening and/or enrollment: - [1] are overtly healthy males or females, as determined by medical history and physical examination - [1a] female subjects: must be of non-childbearing potential con... | [] |
NCT03023826 | 6.2 | Exclusion Criteria | 6.2. Exclusion Criteria Subjects will be excluded from study enrollment if they meet any of the following criteria at screening and/or enrollment: - [9] are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, biological or legal guardia... | [] |
NCT03023826 | 6.3 | Lifestyle and/or Dietary Requirements | 6.3. Lifestyle and/or Dietary Requirements Throughout the study, subjects may undergo medical assessments and review of compliance with requirements before continuing in the study. | [] |
NCT03023826 | 6.3.1 | Meals and Dietary Restrictions | 6.3.1.Meals and Dietary Restrictions Standardized meals will be provided during each subject's stay in the CRU. Subjects will not consume grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruit or star fruit-containing products for at least 7 days prior to the fi... | [
"Administration of LY3202626 in the fasted state",
"Administration of LY3202626 in the fed state",
"Table LLCE.3. High-Fat Meal Composition"
] |
NCT03023826 | 6.3.2 | Xanthine, Alcohol, and Tobacco | 6.3.2.Xanthine, Alcohol, and Tobacco Subjects will be advised to refrain from consuming xanthine-containing food or drinks from 48 hours prior to admission and while resident in the CRU. Subjects will not consume alcohol for 48 hours prior to admission and while resident in the CRU. Smoking will not be permitted throug... | [] |
NCT03023826 | 6.3.3 | Activity | 6.3.3.Activity Subjects should avoid strenuous physical activity for 72 hours before the first dose of LY3202626 until completion of the study. | [] |
NCT03023826 | 6.4 | Screen Failures | 6.4. Screen Failures Individuals who do not meet the criteria for participation in this study (screen failure) may not be re-screened. | [] |
NCT03023826 | 7 | Treatment | 7. Treatment | [] |
NCT03023826 | 7.1 | Treatment Administered | 7.1. Treatment Administered One 12-mg capsule or one 12-mg tablet of LY3202626 will be administered orally with approximately 240 mL of room temperature water in the morning of each dosing day in a sitting position. Subjects will not be allowed to lie supine for 2 hours after dosing, unless clinically indicated or for ... | [] |
NCT03023826 | 7.1.1 | Packaging and Labeling | 7.1.1.Packaging and Labeling The drug product should be stored according to instructions on the label. Clinical trial materials will be labeled according to the country's regulatory requirements. | [] |
NCT03023826 | 7.2 | Method of Treatment Assignment | 7.2. Method of Treatment Assignment Subjects will be randomized to 1 of 6 dose administration sequences using a computer-generated allocation schedule (see Table [LLCE.2\)](#page-16-2). | [] |
NCT03023826 | 7.2.1 | Selection and Timing of Doses | 7.2.1.Selection and Timing of Doses The doses will be administered at approximately the same time on each dosing day. The actual date, time, LY3202626 amount, formulation (capsule-reference or tablet-test) as well as administration condition (fasted or fed) of all dose administrations will be recorded in the subject's ... | [] |
NCT03023826 | 7.3 | Blinding | 7.3. Blinding This is an open-label study. | [] |
NCT03023826 | 7.4 | Dose Modification | 7.4. Dose Modification Dose reductions or adjustments will not be allowed during this study. | [] |
NCT03023826 | 7.5 | Preparation/Handling/Storage/Accountability | 7.5. Preparation/Handling/Storage/Accountability Only participants enrolled in the study may receive investigational product (IP) and only authorized site staff may supply or administer study treatment. All study treatments should be stored in an environmentally controlled and monitored (manual or automated) area in ac... | [] |
NCT03023826 | 7.6 | Treatment Compliance | 7.6. Treatment Compliance The investigational product will be administered at the clinical site, and documentation of dose administration will occur at the site. | [] |
NCT03023826 | 7.7 | Concomitant Therapy | 7.7. Concomitant Therapy Additional drugs are to be avoided during the study unless required to treat an AE. If the need for concomitant medication arises, inclusion or continuation of the subject may be at the discretion of the investigator after consultation with a Lilly clinical pharmacologist (CP) or clinical resea... | [] |
NCT03023826 | 8 | Discontinuation Criteria | 8. Discontinuation Criteria | [] |
NCT03023826 | 8.1 | Discontinuation from Study Treatment | 8.1. Discontinuation from Study Treatment Subjects who discontinue the study early will have procedures performed as shown in the Schedule of Activities (Section [2\)](#page-10-0). | [] |
NCT03023826 | 8.1.1 | Discontinuation of Inadvertently Enrolled Subjects | 8.1.1.Discontinuation of Inadvertently Enrolled Subjects If the Sponsor or investigator identifies a subject who did not meet enrollment criteria and was inadvertently enrolled, the subject will be discontinued from the study and early discontinuation assessments will be performed as described in the Schedule of Activi... | [] |
NCT03023826 | 8.2 | Discontinuation from the Study | 8.2. Discontinuation from the Study Subjects will be discontinued in the following circumstances: - enrollment in any other clinical trial involving an IP or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study - participation in the study needs to be ... | [] |
NCT03023826 | 8.3 | Subjects Lost to Follow-up | 8.3. Subjects Lost to Follow-up A subject will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel are expected to make diligent attempts to contact subjects who fail to return for a scheduled visit or were otherwis... | [] |
NCT03023826 | 9 | Study Assessments and Procedures | 9. Study Assessments and Procedures Section [2](#page-10-0) lists the Schedule of Activities, detailing the study procedures and their timing. [Appendix 2](#page-40-0) lists the laboratory tests that will be performed for this study. [Appendix 4](#page-44-0) provides a summary of the maximum number and volume of invasi... | [] |
NCT03023826 | 9.1 | Efficacy Assessments | 9.1. Efficacy Assessments This section is not applicable for this study. | [] |
NCT03023826 | 9.2 | Adverse Events | 9.2. Adverse Events Investigators are responsible for monitoring the safety of subjects who have entered this study and for alerting Lilly or its designee to any event that seems unusual, even if this event may be considered an unanticipated benefit to the subject. The investigator is responsible for the appropriate me... | [] |
NCT03023826 | 9.2.1 | Serious Adverse Events | 9.2.1.Serious Adverse Events An SAE is any AE from this study that results in one of the following: - death - initial or prolonged inpatient hospitalization - a life-threatening experience (that is, immediate risk of dying) - persistent or significant disability/incapacity - congenital anomaly/birth defect - events con... | [] |
NCT03023826 | 9.2.1.1 | Suspected Unexpected Serious Adverse Reactions | 9.2.1.1. Suspected Unexpected Serious Adverse Reactions Suspected unexpected serious adverse reactions (SUSARs) are serious events that are not listed in the IB and that the investigator identifies as related to investigational product or procedure. United States 21 CFR 312.32 and European Union Clinical Trial Directiv... | [] |
NCT03023826 | 9.2.2 | Complaint Handling | 9.2.2.Complaint Handling Lilly collects product complaints on investigational products and drug delivery systems used in clinical trials in order to ensure the safety of study participants, monitor quality, and to facilitate process and product improvements. Subjects should be instructed to contact the investigator as ... | [] |
NCT03023826 | 9.3 | Treatment of Overdose | 9.3. Treatment of Overdose For the purposes of this study, an overdose of LY3202626 is considered any dose higher than the dose assigned. There is no specific antidote for LY3202626. In the event of overdose, the subject should receive appropriate supportive care and any AEs should be documented. | [] |
NCT03023826 | 9.4 | Safety | 9.4. Safety | [] |
NCT03023826 | 9.4.1 | Laboratory Tests | 9.4.1.Laboratory Tests For each subject, laboratory tests detailed in [Appendix 2](#page-40-0) should be conducted according to the Schedule of Activities (Section [2\)](#page-10-0) and following the manual of operations. | [] |
NCT03023826 | 9.4.2 | Vital Signs | 9.4.2.Vital Signs For each subject, vital sign measurements should be conducted according to the Schedule of Activities (Section [2\)](#page-10-0). Additional unscheduled vital sign measurements may be conducted if clinically indicated. Blood pressure and pulse rate will be measured with automated equipment. Use of the... | [] |
NCT03023826 | 9.4.3 | Body Weight | 9.4.3.Body Weight Body weight will be recorded as specified in the Schedule of Activities (Section [2\)](#page-10-0). | [] |
NCT03023826 | 9.4.4 | Electrocardiograms | 9.4.4.Electrocardiograms For each subject, ECGs should be collected according to the Schedule of Activities (Section [2\)](#page-10-0). Any clinically significant findings from ECGs that result in a diagnosis and that occur after the subject receives the first dose of the IP, should be reported to Lilly, or its designe... | [] |
NCT03023826 | 9.4.5 | Safety Monitoring | 9.4.5.Safety Monitoring The Lilly CP or CRP will monitor safety data throughout the course of the study. Lilly will review SAEs within time frames mandated by company procedures. The Lilly CP or CRP will consult with the functionally independent Global Patient Safety therapeutic area physician or clinical research scie... | [] |
NCT03023826 | 9.5 | Pharmacokinetics | 9.5. Pharmacokinetics At the visits and times specified in the Schedule of Activities (Section [2\)](#page-10-0), venous blood samples of approximately 3 mL each will be collected to determine the plasma concentrations of LY3202626. A maximum of 2 samples may be collected at additional time points during the study if w... | [] |
NCT03023826 | 9.5.1 | Bioanalysis | 9.5.1.Bioanalysis Samples will be analyzed at a laboratory approved by the sponsor and stored at a facility designated by the sponsor. Concentrations of LY3202626 will be assayed using a validated liquid chromatography with tandem mass spectrometric detection method. Bioanalytical samples collected to measure investiga... | [] |
NCT03023826 | 9.6 | Pharmacodynamics | 9.6. Pharmacodynamics At the visits and times specified in the Schedule of Activities (Section [2\)](#page-10-0) venous blood samples of approximately 2 mL will be collected for measurement of plasma Aβ concentrations. Plasma concentrations of Aβ1-40 and Aβ1-42 will be determined using validated immunoassay methods. Th... | [] |
NCT03023826 | 9.7 | Genetics | 9.7. Genetics A blood sample will be collected for pharmacogenetic analysis as specified in the Schedule of Activities (Section [2\)](#page-10-0), where local regulations allow. Samples will not be used to conduct unspecified disease or population genetic research either now or in the future. Samples will be used to in... | [] |
NCT03023826 | 9.8 | Biomarkers | 9.8. Biomarkers This section is not applicable for this study. | [] |
NCT03023826 | 9.9 | Health Economics | 9.9. Health Economics This section is not applicable for this study. | [] |
NCT03023826 | 10 | Statistical Considerations and Data Analysis | 10. Statistical Considerations and Data Analysis | [] |
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