protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04439149 | 1.2 | GSK2636771 | 1.2 GSK2636771 | [] |
NCT04439149 | 1.2.1 | Non-clinical and clinical data | 1.2.1 Non-clinical and clinical data GSK2636771 has been assessed in primary and secondary pharmacodynamic studies, as well as safety, pharmacology and toxicology studies. A summary of the available relevant non-clinical data is provided below. Study details and additional information can be found in the Investigator B... | [] |
NCT04439149 | 1.2.2 | Non-clinical pharmacology | 1.2.2 Non-clinical pharmacology GSK2636771 is a potent and selective inhibitor of phosphoinositide 3 kinase (PI3K) beta with an apparent Ki (Kiapp) value of 0.89 nM with selectivity > 900-fold over PI3K alpha and gamma with Kiapp values of 819 and > 5000 nM, respectively, and 10-fold over PI3K delta (Kiapp of 8.6 nM). ... | [] |
NCT04439149 | 1.2.3 | Non-clinical pharmacokinetics | 1.2.3 Non-clinical pharmacokinetics The pharmacokinetics and metabolism of GSK2636771 have been evaluated both in vitro and in vivo in several preclinical species. GSK2636771 exhibited moderate blood clearance in the mouse and rat (32 and 47% liver blood flow, respectively), but low in the dog and monkey (9 and 2% live... | [] |
NCT04439149 | 1.2.4 | Non-clinical toxicology and safety pharmacology | 1.2.4 Non-clinical toxicology and safety pharmacology The systemic toxicity of GSK2636771 has been evaluated in rats and dogs. Genotoxicity studies have also been conducted. The principal dose-limiting toxicities seen in animal toxicology studies conducted with GSK2636771 were kidney and gastrointestinal effects. There... | [] |
NCT04439149 | 1.3 | Supporting Preliminary Data | 1.3 Supporting Preliminary Data | [] |
NCT04439149 | 1.3.1 | Clinical Data | 1.3.1 Clinical Data To date, the administration of GSK2636771 has been limited to 53 subjects with PTEN deficient tumors as determined by immunohistochemistry (IHC) analysis who were enrolled in the FIM study P3B115717.25 The dose escalation part of the study has completed, and is now in an expansion phase enrolling pa... | [] |
NCT04439149 | 1.3.2 | Safety | 1.3.2 Safety Dose limiting toxicities (DLTs) observed were hypophosphatemia and hypocalcemia. Dose-limiting toxicity (DLT) of hypophosphatemia was identified at 500 mg daily dose level, occurring in 3 of 4 subjects, and resulting in dose reductions and or discontinuations. Hypophosphatemia improved upon discontinuation... | [] |
NCT04439149 | 1.3.3 | Pharmacokinetics | 1.3.3 Pharmacokinetics Preliminary pharmacokinetics (PK) results from study P3B115717 indicate that GSK2636771 is absorbed orally with a median time to achieve the peak blood concentration (tmax) of 4 to 5 hrs after single doses of 25 to 500 mg. The median half-life of GSK2636771 ranged from 17.1 to 38.6 hrs across the... | [] |
NCT04439149 | 1.3.4 | Efficacy | 1.3.4 Efficacy There are limited data available to assess the clinical activity of GSK2636771. In the FTIH study P3B115717 in patients with PTEN deficiency as determined by IHC, one subject with mCRPC who received 200 mg GSK2636771 once daily had a partial response (PR) per RECIST. There were 16 subjects (with various ... | [] |
NCT04439149 | 2 | Selection of Patients | 2. Selection of Patients Each of the criteria in the checklist that follows must be met, along with the eligibility in the MATCH Master Protocol, in order for a patient to be considered eligible for this study. Use the checklist to confirm a patient's eligibility. For each patient, this checklist must be photocopied, c... | [
"Cancer Research Group Version Date: February 6, 2017"
] |
NCT04439149 | 3 | GSK2636771 Treatment Plan | 3. GSK2636771 Treatment Plan
Rev. 12/16 | [
"Rev. 12/16"
] |
NCT04439149 | 3.1 | Administration Schedule | 3.1 Administration Schedule GSK2636771 will be administered on an oral, daily, continuous administration schedule. The starting dose of the drug will be 400mg (four 100 mg capsules), once daily which was deemed the maximum tolerated phase II dose from the company sponsored phase I study. Each cycle of therapy will be 2... | [] |
NCT04439149 | 3.2 | Adverse Event Reporting Requirements | 3.2 Adverse Event Reporting Requirements The Adverse Event Reporting Requirements for all EAY131 subprotocols are outlined in the MATCH MASTER protocol. Please refer to those guidelines when determining if an event qualifies as a Serious Adverse Event (SAE) and requires expedited reporting via CTEP's Adverse Event Repo... | [
"Additional Instructions",
"EAY131 – Subprotocol N specific expedited reporting requirements:",
"EAY131 – Subprotocol N specific expedited reporting exceptions:"
] |
NCT04439149 | 3.2.2 | Second Primary Cancer Reporting Requirements | 3.2.2 Second Primary Cancer Reporting Requirements All cases of second primary cancers, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), that occur following treatment on NCI-sponsored trials must be reported to ECOG-ACRIN using Medidata Rave - A second malignancy is a cancer that is UNRELATED... | [] |
NCT04439149 | 33 | Comprehensive Adverse Events and Potential Risks List (CAEPR) for GSK2636771 (NSC 781258) | 33 Comprehensive Adverse Events and Potential Risks List (CAEPR) for GSK2636771 (NSC 781258) | 33 | Comprehensive Adverse Events and Potential Risks List (CAEPR) forGSK2636771 (NSC 781258) | | | | |-------------------------------------|------------------------------------------------------------------------------------... | [
"Dogs",
"Rats",
"3.4 Dose Modifications Rev. 12/16",
"Dose Reduction Table:",
"Renal Insufficiency/ Creatinine Increased:",
"Neutropenia:",
"Thrombocytopenia:",
"Liver Function Tests (bilirubin, AST and ALT):",
"Hypophosphatemia: Rev. 12/16",
"3.5 Supportive Care",
"3.6 Duration of Agent-specifi... |
NCT04506619 | 1 | BACKGROUND INFORMATION | 1. BACKGROUND INFORMATION SHP607 (mecasermin rinfabate, rhIGF-1/rhIGFBP-3) is the recombinant human version of the naturally occurring protein complex of insulin-like growth factor-1 (IGF-1) and its most abundant binding protein, insulin-like growth factor binding protein-3 (IGFBP-3). rhIGF-1/rhIGFBP-3 was approved by ... | [] |
NCT04506619 | 1.1 | Indication and Current Treatment Options | 1.1 Indication and Current Treatment Options Extremely premature infants are at very high risk for developing morbidities such as BPD, intraventricular hemorrhage (IVH), and retinopathy of prematurity (ROP), often resulting in delayed mortality or long-term disabilities. In fact, a simple count of the number of comorbi... | [] |
NCT04506619 | 1.1.1 | Bronchopulmonary Dysplasia and Long-Term Respiratory Complications | 1.1.1 Bronchopulmonary Dysplasia and Long-Term Respiratory Complications Bronchopulmonary dysplasia is a chronic lung disorder that is among the most common morbidities of preterm birth with an increased incidence with lower gestational age (GA) and birth weight, affecting at least one-quarter of infants born with weig... | [] |
NCT04506619 | 1.1.2 | Intraventricular Hemorrhage | 1.1.2 Intraventricular Hemorrhage Intraventricular hemorrhage is estimated to occur in 20-25% of preterm infants with very low birth weight (<1500 g) in the US and is characterized initially by hemorrhage into the germinal matrix tissues of the developing brain ([McCrea and Ment, 2008](#page-68-0)). In the US between 1... | [] |
NCT04506619 | 1.1.3 | Retinopathy of Prematurity | 1.1.3 Retinopathy of Prematurity Retinopathy of prematurity is a major cause of blindness in children in the developed and developing world, despite current treatment of late-stage ROP ([Silverman, 1980](#page-69-0)). As developing countries provide more neonatal and maternal intensive care, the incidence of ROP has in... | [] |
NCT04506619 | 1.1.4 | Other Complications of Prematurity | 1.1.4 Other Complications of Prematurity Extremely premature infants have recognized instability in glycemic control that includes both hypoglycemia ([Lubchenco and Bard, 1971;](#page-68-0) [Wybregt et al., 1964](#page-70-0)) and hyperglycemia [\(Dweck](#page-65-0) [and Cassady, 1974](#page-65-0)) events throughout the... | [] |
NCT04506619 | 1.2 | Product Background and Clinical Information | 1.2 Product Background and Clinical Information SHP607 is the recombinant protein complex of IGF-1 and its most abundant binding protein, IGFBP-3. In animal studies, SHP607 displays metabolic activities similar to those observed with rhIGF-1. In healthy individuals, IGF-1 is constantly present in the bloodstream. In th... | [] |
NCT04506619 | 1.2.1 | Nonclinical Information | 1.2.1 Nonclinical Information Appropriate PK, toxicokinetic, biodistribution, and toxicology studies have been performed in rats and monkeys, the 2 species used for nonclinical toxicology testing. In rats and monkeys, PK studies with SHP607, as compared to those with either rhIGF-1 or rhIGFBP-3 administered as single a... | [] |
NCT04506619 | 1.2.2 | Clinical Experience with SHP607 | 1.2.2 Clinical Experience with SHP607 Two clinical studies, ROPP-2005-01 and ROPP-2008-01, have been conducted with SHP607 in premature infants. A third study, SHP607-201, is being conducted to assess the long-term efficacy and safety outcomes of SHP607 versus standard neonatal care (no investigational product is being... | [] |
NCT04506619 | 1.3 | Study Rationale | 1.3 Study Rationale Despite significant advances in care over the past 20 years, extremely premature infants remain at very high risk for developing morbidities that affect multiple organ systems and often result in delayed mortality or long-term disabilities. Additional therapeutic and preventive options are very much... | [] |
NCT04506619 | 1.4 | Benefit/Risk Assessment | 1.4 Benefit/Risk Assessment Always refer to the latest version of the SHP607 IB for the overall benefit/risk assessment and the most accurate and current information regarding drug metabolism, pharmacokinetics, efficacy, and safety of SHP607. | [] |
NCT04506619 | 1.5 | Compliance Statement | 1.5 Compliance Statement This study will be conducted in accordance with this protocol, the International Council for Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP, 1996; E6 R2, 2017), Title 21 of the US Code of Federal Regulations (US CFR), the EU Directives (2001/20/EC; 2005/28/EC), and applicable na... | [] |
NCT04506619 | 2 | STUDY OBJECTIVES AND PURPOSE | 2. STUDY OBJECTIVES AND PURPOSE | [] |
NCT04506619 | 2.1 | Study Objectives | 2.1 Study Objectives | [] |
NCT04506619 | 2.1.1 | Primary Objectives | 2.1.1 Primary Objectives The primary objectives of this study are: - To evaluate long-term efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group, as assessed by CRM outcomes. - To evaluate the long-term safety outcomes following previously admin... | [] |
NCT04506619 | 2.1.2 | Secondary Objectives | 2.1.2 Secondary Objectives The secondary objectives of this study are to evaluate long-term effects following previously administered short-term exposure to SHP607 on growth, cognitive and motor development, behavior, and resource utilization, as compared to a standard neonatal care group, by assessing: - Growth parame... | [] |
NCT04506619 | 2.1.3 | Exploratory Objectives | 2.1.3 Exploratory Objectives The exploratory objectives of this study are: - To evaluate caregiver burden as assessed by the Caregiver Impact Questionnaire (CIQ). - To evaluate caregiver health status using EuroQol 5-dimensional 5-level descriptive system (EQ-5D-5L). - To evaluate cognitive impairment with an explorato... | [] |
NCT04506619 | 3 | STUDY DESIGN | 3. STUDY DESIGN | [] |
NCT04506619 | 3.1 | Study Design and Flow Chart | 3.1 Study Design and Flow Chart This is a Phase 2b, multicenter, long-term outcomes study of subjects who were randomized in Study SHP607-202 to either treatment (received SHP607) or control (received standard neonatal care) groups. Subjects will be followed from 12 months CA through 5 years CA. Subjects will not be ex... | [] |
NCT04506619 | 3.2 | Duration and Study Completion Definition | 3.2 Duration and Study Completion Definition The subject's maximum duration of participation is expected to be approximately 4 years. The study will be completed in approximately 8 years. The Study Completion Date is defined as the date on which the last subject in the study completes the final protocol-defined assessm... | [] |
NCT04506619 | 3.3 | Sites and Regions | 3.3 Sites and Regions The study will be conducted at approximately 60 sites including, but not limited to, countries in the following regions: North America, Europe, and Asia Pacific (APAC). | [] |
NCT04506619 | 4 | STUDY POPULATION | 4. STUDY POPULATION Subjects who previously received SHP607 or standard neonatal care in Study SHP607-202 are planned to be enrolled in Study SHP607-203. Subjects in Study SHP607-202 are premature infants (GA of 23 weeks +0 days to 27 weeks +6 days) who are randomized to receive either treatment with SHP607 at 250 ug/k... | [] |
NCT04506619 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria Subjects must meet all of the criteria below. - 1. Subject was randomized into Study SHP607-202. Subjects who were randomized, but did not complete Study SHP607-202 must be at least 12 months CA. - 2. Written informed consents (and assents, if applicable) must be signed and dated by the subject's... | [] |
NCT04506619 | 4.2 | Exclusion Criterion | 4.2 Exclusion Criterion Subjects are excluded from the study if the subject or subject's parent(s)/legally authorized representative(s) is/are unable to comply with the protocol or is/are unlikely to be available for long-term follow-up as determined by the investigator. | [] |
NCT04506619 | 4.3 | Discontinuation of Subjects | 4.3 Discontinuation of Subjects A parent or legally authorized representative may withdraw the subject from the study at any time for any reason without prejudice to their future medical care by the physician or at the institution. The investigator or sponsor may withdraw the subject at any time (eg, in the interest of... | [] |
NCT04506619 | 4.3.1 | Reasons for Discontinuation | 4.3.1 Reasons for Discontinuation The reason for withdrawal must be determined by the investigator and recorded in the subject's medical record and on the case report form (CRF). If a subject is withdrawn for more than 1 reason, each reason should be documented in the source document and the most clinically relevant re... | [] |
NCT04506619 | 4.3.2 | Subjects "Lost to Follow-up" Prior to Last Scheduled Visit | 4.3.2 Subjects "Lost to Follow-up" Prior to Last Scheduled Visit A minimum of 3 documented attempts must be made to contact the parent(s)/legally authorized representative(s) of any subject lost to follow-up at any time point prior to the last scheduled contact (office visit or telephone contact). At least 1 of these d... | [] |
NCT04506619 | 5 | PRIOR AND CONCOMITANT TREATMENT | 5. PRIOR AND CONCOMITANT TREATMENT | [] |
NCT04506619 | 5.1 | Prior Treatment | 5.1 Prior Treatment Not applicable as no investigational product will be administered in this study. | [] |
NCT04506619 | 5.2 | Concomitant Treatment and Medications | 5.2 Concomitant Treatment and Medications Medications, procedures, and therapies administered to study subjects from the time of informed consent through the 5 year CA visit (or until the subject is withdrawn or discontinued) will be collected, only in the context of SAEs. In addition, respiratory medications (and medi... | [] |
NCT04506619 | 6 | INVESTIGATIONAL PRODUCT | 6. INVESTIGATIONAL PRODUCT | [] |
NCT04506619 | 6.1 | Identity of Investigational Product | 6.1 Identity of Investigational Product Not applicable as no investigational product will be administered in this study. | [] |
NCT04506619 | 6.2 | Administration of Investigational Product | 6.2 Administration of Investigational Product Not applicable. | [] |
NCT04506619 | 6.3 | Labeling, Packaging, Storage, and Handling | 6.3 Labeling, Packaging, Storage, and Handling Not applicable. | [] |
NCT04506619 | 7 | STUDY PROCEDURES | 7. STUDY PROCEDURES | [] |
NCT04506619 | 7.1 | Study Schedule | 7.1 Study Schedule See [Table](#page-16-0) 1 for study procedures. The timing of all study visits is based on subjects' CA. Although Study SHP607-202 is open-label, measures will be instituted in Study SHP607-203 to blind selected site personnel who are involved in efficacy assessments in order to minimize bias in stud... | [] |
NCT04506619 | 7.1.1 | Initial Study Visit (12 Months CA) | 7.1.1 Initial Study Visit (12 Months CA) In general, the initial visit in Study SHP607-203 should coincide with the final visit of the primary Study SHP607-202 at 12 months CA +2 weeks. At the initial visit, informed consent will be obtained followed by an assessment of study eligibility criteria and collection of demo... | [] |
NCT04506619 | 7.1.2 | Study Visits | 7.1.2 Study Visits Study visits will take place at the following time points in CA: - 18 months (±6 weeks); conducted by telephone - 24 months (±6 weeks); clinical site visit - 30 months (±6 weeks); conducted by telephone - 3 years (±6 weeks); conducted by telephone - 3.5 years (±6 weeks); conducted by telephone - 4 ye... | [] |
NCT04506619 | 7.1.2.1 | Assessments Conducted by Telephone | 7.1.2.1 Assessments Conducted by Telephone Visits at 18 months, 30 months, 3 years, 3.5 years, 4 years, and 4.5 years CA will be conducted by telephone. The following assessments will be conducted at each of these 6 visits, unless otherwise indicated: - Pulmonary morbidity assessment - Pediatric Quality of Life Invento... | [] |
NCT04506619 | 7.1.2.2 | Assessments Conducted at Clinical Site Visits | 7.1.2.2 Assessments Conducted at Clinical Site Visits Visits at 24 months and 5 years CA will be conducted at clinical site visits. The following assessments will occur at these visits: - 24 months (±6 weeks) - Body weight and height/length - Head circumference - Bayley Scales of Infant and Toddler Development (BSID) (... | [] |
NCT04506619 | 7.1.3 | Additional Care of Subjects after the Study | 7.1.3 Additional Care of Subjects after the Study No aftercare is planned for this study. | [] |
NCT04506619 | 7.2 | Study Evaluations and Procedures | 7.2 Study Evaluations and Procedures | [] |
NCT04506619 | 7.2.1 | Informed Consent | 7.2.1 Informed Consent Prior to conducting any study-related procedures, written informed consent must be obtained from the subject's parent(s) or legally authorized representative(s). Since the subjects cannot provide any information and decide for themselves, the parents or legally authorized representatives of the s... | [] |
NCT04506619 | 7.2.2 | Study Entrance Criteria | 7.2.2 Study Entrance Criteria At the initial visit, each subject will be reviewed for eligibility against the study entrance criteria. Subjects who do not meet the study entrance criteria will not be allowed to participate in the study. The reason(s) for the subject's ineligibility for the study will be documented. No ... | [] |
NCT04506619 | 7.2.3 | Study Enrollment | 7.2.3 Study Enrollment At the initial visit, subjects meeting study entrance criteria will be enrolled. | [] |
NCT04506619 | 7.2.4 | Demographic and Other Baseline Characteristics | 7.2.4 Demographic and Other Baseline Characteristics Subject demographic information including sex, date of birth, and ethnicity will be recorded at the initial visit. | [] |
NCT04506619 | 7.2.5 | Efficacy | 7.2.5 Efficacy | [] |
NCT04506619 | 7.2.5.1 | Pulmonary Morbidity Assessment | 7.2.5.1 Pulmonary Morbidity Assessment Pulmonary morbidity will be assessed through an interviewer-administered questionnaire at the clinical site at 12 months (only for subjects who did not complete Study SHP607-202), 24 months and 5 years CA and by telephone visits at 18 months, 30 months, 3 years, 3.5 years, 4 years... | [] |
NCT04506619 | 7.2.5.2 | Growth Parameters | 7.2.5.2 Growth Parameters
Body Length and Height Body length (supine measurement) will be collected at the 12 months and 24 months CA visit. For the length measurement, the subject will be placed on his or her back so that the subject is lying straight and the shoulders and buttocks are flat against the measuring surf... | [
"Body Length and Height",
"Body Weight",
"Head Circumference"
] |
NCT04506619 | 7.2.5.3 | Visual Acuity | 7.2.5.3 Visual Acuity Visual acuity is a measure of how well a subject sees at different distances. Measurements will be recorded for the left (OS), right (OD), and both eyes (OU). Visual acuity will be attempted at 5 years CA by the LEA Symbols Chart. | [] |
NCT04506619 | 7.2.5.4 | Vision and Hearing Assessment History | 7.2.5.4 Vision and Hearing Assessment History Results of previously completed vision and hearing assessments, if performed, may be recorded at any time during the study up to the 5 year CA visit. Visual acuity will be measured at 5 years CA (see Section [7.2.5.3\)](#page-41-0), but hearing tests are not being performed... | [] |
NCT04506619 | 7.2.5.5 | Cognitive and Behavioral Assessments | 7.2.5.5 Cognitive and Behavioral Assessments Bayley Scales of Infant and Toddler Development (BSID) The BSID will be used to assess cognitive, motor, and language skills at the 24 months CA visit. The BSID is an assessment tool designed to measure a young child's skills in the 5 domains of development: cognitive, langu... | [
"Kyoto Scale of Psychological Development (KSPD)",
"Wechsler Preschool and Primary Scale of Intelligence (WPPSI)",
"Gross Motor Function Measure-88 (GMFM)",
"Vineland Adaptive Behavior Scales (VABS)",
"Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS)",
"Social Communication Questionnaire – ... |
NCT04506619 | 7.2.5.6 | Health Economic Outcome Research Assessments | 7.2.5.6 Health Economic Outcome Research Assessments Health-related quality of life (HRQoL) is an important measure of health status or well-being and can be influenced by clinical interventions. It is an important concept used in determining the value of health care services and can serve as a screening tool for ident... | [
"Pediatric Quality of Life Inventory (PedsQL) Infant Scales",
"EQ-5D-5L",
"Health Care Resource Use (HCRU)",
"Health Utilities Index (HUI)",
"Caregiver Impact Questionnaire (CIQ)"
] |
NCT04506619 | 7.2.5.7 | BabyScreen Assessment (Optional) | 7.2.5.7 BabyScreen Assessment (Optional) BabyScreen is an interactive electronic tablet application to evaluate cognitive impairment, used by preterm children at approximately 24 months CA. The tool is engaging, with colorful screens and visual prompts that capture the attention of the child and promote engagement and ... | [] |
NCT04506619 | 7.2.5.8 | Spirometry (Optional) | 7.2.5.8 Spirometry (Optional) Spirometry will be performed at the 5-year visit. Standard measures will be collected, including forced expiratory volume over 1 second (FEV1) and forced vital capacity (FVC). Participation is optional and has no impact on participating in the main study. Participation is limited to select... | [] |
NCT04506619 | 7.2.6 | Cerebral Magnetic Resonance Imaging (Optional) | 7.2.6 Cerebral Magnetic Resonance Imaging (Optional) Participation in the MRI assessment is optional, limited to sites that participated in the MRI assessment in Study SHP607-202, and has no impact on participating in the main study. If consented to, MRI of the brain will be performed. Volumetric analyses of the cortic... | [] |
NCT04506619 | 7.2.7 | Safety | 7.2.7 Safety | [] |
NCT04506619 | 7.2.7.1 | Medical History | 7.2.7.1 Medical History Medical events or conditions should only be captured as medical history if they occur after the end of the subject's participation in the primary Study SHP607-202 and before informed consent in the current Study SHP607-203. | [] |
NCT04506619 | 7.2.7.2 | Physical Examination | 7.2.7.2 Physical Examination Physical examinations will include a general examination (including assessment of tonsillar hypertrophy) and a neurological examination ([Table](#page-46-0) 2). Examinations will be performed at the time points specified in the Schedule of Assessments [\(Table](#page-16-0) 1). Table 2 Asses... | [] |
NCT04506619 | 7.2.7.3 | Blood Pressure, Heart Rate, and Respiratory Rate | 7.2.7.3 Blood Pressure, Heart Rate, and Respiratory Rate Blood pressure, heart rate, and respiratory rate will be measured at the 12-month, 24-month, and 5-year CA visits. | [] |
NCT04506619 | 7.2.7.4 | Adverse Event Collection | 7.2.7.4 Adverse Event Collection At each study visit, subjects will be questioned in a general way to ascertain if AEs have occurred since the previous visit (eg, "Have you had any health problems since your last visit?"). Please refer to Section [8,](#page-48-0) Adverse and Serious Adverse Events Assessment. | [] |
NCT04506619 | 7.2.8 | Medication Assessment | 7.2.8 Medication Assessment All medications received by study subjects will be collected from the time of enrollment through the 5-year CA visit (or upon discontinuation). Any investigational product received by subjects will be recorded separately as part of an assessment of subjects' participation in other clinical s... | [] |
NCT04506619 | 7.2.9 | Participation in Other Clinical Studies | 7.2.9 Participation in Other Clinical Studies Following enrollment, subjects in this study will not be restricted from enrolling in other clinical studies that involve the use of investigational product. The status of a subject's participation in such studies will be recorded (ie, yes/no). If a subject is enrolled in s... | [] |
NCT04506619 | 7.2.10 | Appropriateness of Measurements | 7.2.10 Appropriateness of Measurements Overall, the primary and secondary efficacy and safety measures being employed in this study are considered appropriate for the follow-up of preterm infants. The validated tools being used to assess neurodevelopment, physical development, and health economic research outcomes in t... | [] |
NCT04506619 | 8 | ADVERSE AND SERIOUS ADVERSE EVENTS ASSESSMENT | 8. ADVERSE AND SERIOUS ADVERSE EVENTS ASSESSMENT | [] |
NCT04506619 | 8.1 | Definition of Adverse Events, Period of Observation, Recording of Adverse Events | 8.1 Definition of Adverse Events, Period of Observation, Recording of Adverse Events According to the International Conference on Harmonization (ICH), an AE is "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a caus... | [] |
NCT04506619 | 8.1.1 | Severity Categorization | 8.1.1 Severity Categorization The severity of AEs must be recorded during the course of the event including the start and stop dates for each change in severity. An event that changes in severity should be captured as a new event. The medical assessment of severity is determined by using the following definitions: Mild... | [] |
NCT04506619 | 8.1.2 | Relationship Categorization | 8.1.2 Relationship Categorization A physician/investigator must make the assessment of relationship to prior investigational product for each AE. The investigator should decide whether, in his or her medical judgment, there is a reasonable possibility that the event may have been caused by the investigational product. ... | [] |
NCT04506619 | 8.1.3 | Outcome Categorization | 8.1.3 Outcome Categorization The outcome of AEs must be recorded during the course of the study on the CRF. Outcomes are as follows: - Fatal - Not recovered/Not Resolved - Recovered/Resolved - Recovered/Resolved With Sequelae - Recovering/Resolving - Unknown | [] |
NCT04506619 | 8.1.4 | Targeted Medical Events | 8.1.4 Targeted Medical Events If it is determined that any of the following targeted medical events have been experienced by a subject, they will be recorded as AEs or SAEs (refer to Section [8.2.3\)](#page-51-0), as appropriate, regardless of relationship to prior investigational product (SHP607 as administered in Stu... | [] |
NCT04506619 | 8.1.5 | Clinical Laboratory and Other Safety Evaluations | 8.1.5 Clinical Laboratory and Other Safety Evaluations A change in the value of a clinical laboratory or vital sign assessment can represent an AE if the change is clinically relevant. When evaluating such changes, the extent of deviation from the reference range, the duration until return to the reference range, and t... | [] |
NCT04506619 | 8.1.6 | Abuse, Misuse, Overdose, and Medication Errors | 8.1.6 Abuse, Misuse, Overdose, and Medication Errors Not applicable. | [] |
NCT04506619 | 8.2 | Serious Adverse Event Procedures | 8.2 Serious Adverse Event Procedures | [] |
NCT04506619 | 8.2.1 | Reference Safety Information | 8.2.1 Reference Safety Information Investigators should refer to the most current version of the SHP607 IB for reference safety information, which is found in IB Section 6, Summary of Data and Guidance for the Investigator. | [] |
NCT04506619 | 8.2.2 | Reporting Procedures | 8.2.2 Reporting Procedures All initial and follow-up SAE reports must be reported by the investigator to Shire Global Drug Safety within 24 hours of the first awareness of the event. The investigator must complete, sign, and date the Shire Clinical Study Serious Adverse Event and Non-serious AEs Required by the Protoco... | [] |
NCT04506619 | 8.2.3 | Serious Adverse Event Definition | 8.2.3 Serious Adverse Event Definition An SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: - Results in death - Is life-threatening. Note: The term "life-threatening" in the definition of "serious" refers to an event... | [] |
NCT04506619 | 8.2.4 | Serious Adverse Event Collection Time Frame | 8.2.4 Serious Adverse Event Collection Time Frame All SAEs (regardless of relationship to study drug) are collected from the time the subject signs the informed consent until the defined follow-up period stated in Section [7.1.2](#page-37-0) and must be reported to Shire Global Drug Safety within 24 hours of the first ... | [] |
NCT04506619 | 8.2.5 | Serious Adverse Event Onset and Resolution Dates | 8.2.5 Serious Adverse Event Onset and Resolution Dates The onset date of the SAE is defined as the date the event meets serious criteria. The resolution date is the date the event no longer meets serious criteria, the date the symptoms resolve, or the date the event is considered chronic. In the case of hospitalization... | [] |
NCT04506619 | 8.2.6 | Fatal Outcome | 8.2.6 Fatal Outcome Any SAE that results in the subject's death (ie, the SAE was assessed as the primary cause of death) must have fatal checked as an outcome with the date of death recorded as the resolution date. For all other events ongoing at the time of death that did not contribute to the subject's death, the out... | [] |
NCT04506619 | 8.2.7 | Regulatory Agency, Institutional Review Board, Ethics Committee, and Site Reporting | 8.2.7 Regulatory Agency, Institutional Review Board, Ethics Committee, and Site Reporting The sponsor and clinical contract research organization (CRO) are responsible for notifying the relevant regulatory authorities and US central IRBs/European Union (EU) central ethics committees (ECs) of related, unexpected SAEs. I... | [] |
NCT04506619 | 9 | DATA MANAGEMENT AND STATISTICAL METHODS | 9. DATA MANAGEMENT AND STATISTICAL METHODS | [] |
NCT04506619 | 9.1 | Data Collection | 9.1 Data Collection The investigators' authorized site personnel must enter the information required by the protocol on the CRF. A study monitor will visit each site in accordance with the monitoring plan and review the CRF data against the source data for completeness and accuracy. Discrepancies between source data an... | [] |
NCT04506619 | 9.2 | Clinical Data Management | 9.2 Clinical Data Management Data are to be entered into a clinical database as specified in the CRO's data management plan. Quality control and data validation procedures are applied to ensure the validity and accuracy of the clinical database. Data are to be reviewed and checked for omissions, errors, and values requ... | [] |
NCT04506619 | 9.3 | Statistical Analysis Process | 9.3 Statistical Analysis Process The study will be analyzed by the sponsor or its agent. The statistical analysis plan (SAP) will provide the statistical methods and definitions for the analysis of the efficacy and safety data, as well as describe the approaches to be taken for summarizing other study information such ... | [] |
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