protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03268941 | 5.2.3 | Trial Exploratory Objectives | 5.2.3 Trial Exploratory Objectives Exploratory objectives of this study are: | [] |
NCT03268941 | 5.3 | Endpoints | 5.3 Endpoints | [] |
NCT03268941 | 5.3.1 | Primary Safety Endpoint | 5.3.1 Primary Safety Endpoint The primary safety endpoint of the study is key safety and tolerability as assessed through physical examinations, vital signs, ECG, and laboratory assessments, as well as collection of serious and nonserious AEs. | [] |
NCT03268941 | 5.3.2 | Secondary Endpoints | 5.3.2 Secondary Endpoints Secondary endpoints include: - 1. The change in serum prolactin from Baseline to Day 1 at time of first occurrence of Cmax (tmax) for TAK-906 following administration with TAK-906 maleate vs placebo. - 2. The change from Baseline to Day 7 in GEBT gastric half-emptying time as measured by the 1... | [] |
NCT03268941 | 5.3.3 | Exploratory Endpoints | 5.3.3 Exploratory Endpoints Exploratory endpoints will be assessed through the following parameters:  | [] |
NCT03268941 | 6.0 | TRIAL DESIGN AND DESCRIPTION | 6.0 TRIAL DESIGN AND DESCRIPTION | [] |
NCT03268941 | 6.1 | Trial Design | 6.1 Trial Design This is a phase 2a, randomized, double-blind and open-label, placebo and active-comparator controlled trial to evaluate the safety, PK, and PD for TAK-906 in subjects with DG or IG. The trial will consist of 2 parts and is designed to allow all enrolled subjects to participate in each part of the study... | [] |
NCT03268941 | 6.1.1 | Part 1 | 6.1.1 Part 1 As shown in [Table 6.a,](#page-20-3) approximately 48 subjects will be randomized into 1 of 3 active treatment arms or a placebo arm to receive trial drug in a double-dummy manner for 9 consecutive days, for a total of 17 doses (ie, BID Days 1 to 8 and morning dose on Day 9). All trial drug dosing will be ... | [] |
NCT03268941 | 6.1.2 | Part 2 | 6.1.2 Part 2 An assessment of the food effect on PK of TAK-906, and separately, a comparison of TAK-906 to an active comparator (metoclopramide) will be assessed in Part 2, the open-label period of the study. All subjects who participated in Part 1 of the study are eligible to participate in all treatment groups in Par... | [] |
NCT03268941 | 6.2 | Rationale for Trial Design, Dose, and Endpoints | 6.2 Rationale for Trial Design, Dose, and Endpoints | [] |
NCT03268941 | 6.2.1 | Rationale of Trial Design | 6.2.1 Rationale of Trial Design This study was designed as a randomized, double-blind (Part 1) and open-label (Part 2), placebo and active-comparator controlled study in men and women with DG or IG. Since diabetes mellitus affects both genders, it is important to include both men and women into the study. In a review o... | [] |
NCT03268941 | 6.2.2 | Rationale for Dose | 6.2.2 Rationale for Dose Data from the phase 1 single- and multiple-ascending dose (SAD and MAD) trial in healthy volunteers were used to select doses for the phase 2a trial. Several considerations were given to dose selection: safety, tolerability, PK, and PD (prolactin). Prolactin has been used as a measure of (b) A ... | [] |
NCT03268941 | 6.2.3 | Rationale for Endpoints | 6.2.3 Rationale for Endpoints The PK, PD, and safety measurements in this study are used widely and are recognized as reliable, accurate, and relevant. DA inhibits prolactin production by pituitary lactotroph cells. Thus, when the D2 receptor is inhibited, serum prolactin levels rise and can serve as a marker for D2 DA... | [] |
NCT03268941 | 6.2.4 | Critical Procedures Based on Trial Objectives: Timing of Procedures | 6.2.4 Critical Procedures Based on Trial Objectives: Timing of Procedures For this trial, timing of the SmartPill, GEBT, and timing of meals relative to study drug administration are critical procedures. Specifically: - ! The SmartPill capsule should be ingested immediately following the completion of the test meal at ... | [] |
NCT03268941 | 6.3 | Trial Design/Dosing/Procedures Modifications Permitted Within Protocol Parameters | 6.3 Trial Design/Dosing/Procedures Modifications Permitted Within Protocol Parameters This is a phase 2a assessment of TAK-906 maleate in humans, and the PK, PD, and safety profiles of the compound are still being elucidated. This protocol is written with some flexibility to accommodate the inherent dynamic nature of p... | [] |
NCT03268941 | 6.4 | Trial Beginning and End/Completion | 6.4 Trial Beginning and End/Completion | [] |
NCT03268941 | 6.4.1 | Definition of Beginning of the Trial | 6.4.1 Definition of Beginning of the Trial The overall trial begins when the first subject signs the trial informed consent form. | [] |
NCT03268941 | 6.4.2 | Definition of End of the Trial | 6.4.2 Definition of End of the Trial The overall trial ends when the last subject completes the last planned or follow-up visit/interaction associated with a planned visit (this can be a phone contact), discontinues from the trial or is lost to follow-up (ie, the investigator is unable to contact the subject). | [] |
NCT03268941 | 6.4.3 | Definition of Trial Discontinuation | 6.4.3 Definition of Trial Discontinuation A primary objective of this early phase 2a trial is to identify dose and/or dosing regimen that achieves PK, PD, and/or biologic targets in humans based on preclinical or early clinical data. Therefore, it is possible that trial subjects may not receive all doses specified in t... | [] |
NCT03268941 | 6.4.3.1 | Criteria for Premature Termination or Suspension of the Trial or Trial Sites | 6.4.3.1 Criteria for Premature Termination or Suspension of the Trial or Trial Sites A trial site may be terminated prematurely or suspended if the site (including the investigator) is found in significant violation of Good Clinical Practices (GCP), protocol, or contractual agreement, is unable to ensure adequate perfo... | [] |
NCT03268941 | 7.0 | SELECTION AND DISCONTINUATION/WITHDRAWAL OF SUBJECTS | 7.0 SELECTION AND DISCONTINUATION/WITHDRAWAL OF SUBJECTS | [] |
NCT03268941 | 7.1 | Inclusion Criteria | 7.1 Inclusion Criteria In order to be eligible for participation in this trial, the subject must: - 1. Understand the study procedures and agree to participate by providing written informed consent. - 2. Be willing and able to comply with all study procedures and restrictions. - 3. Has a documented diagnosis of diabeti... | [] |
NCT03268941 | 7.2 | Exclusion Criteria | 7.2 Exclusion Criteria The subject must be excluded from participating in the trial if the subject: - 1. Subjects who have a history of clinically significant endocrine (apart from diabetes mellitus), GI (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, ren... | [] |
NCT03268941 | 7.3 | Excluded Medications, Supplements, Dietary Products | 7.3 Excluded Medications, Supplements, Dietary Products | [] |
NCT03268941 | 7.3.1 | Prohibited Medications | 7.3.1 Prohibited Medications - 7.3.1.1 Medications Which May Alter Gastric pH (for SmartPill) - 1. Proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, dexlansoprazole, pantoprazole, rabeprazole) for 7 days prior to study, including the day of SmartPill ingestion. - 2. Histamine2 receptor antagonists (cimeti... | [] |
NCT03268941 | 7.3.1.2 | Medications That May Affect Gastrointestinal Motility | 7.3.1.2 Medications That May Affect Gastrointestinal Motility The following medications must be discontinued at least 10 days prior to assessment of GP on Day -1, including the day of SmartPill ingestion (if subject develops nausea to the degree that study discontinuation is contemplated, he or she may take promethazin... | [] |
NCT03268941 | 7.3.1.3 | Medications to Treat Nausea | 7.3.1.3 Medications to Treat Nausea The following medications must be discontinued at least 10 days prior to assessment of GP on Day -1, including the day of SmartPill ingestion: 1. Aprepitant, dolasetron, granisetron, ondansetron, palonosetron, and prochlorperazine. | [] |
NCT03268941 | 7.3.2 | Permitted Medications | 7.3.2 Permitted Medications Prescription medications for maintenance of stabilized conditions (eg, hyperlipidemia, thyroid disease, chronic anxiety or depression, birth control, etc) are permitted if the condition and the dose are stable for 3 months prior to study participation. Use of excluded agents (prescription or... | [] |
NCT03268941 | 7.4 | Diet, Fluid, Activity | 7.4 Diet, Fluid, Activity | [] |
NCT03268941 | 7.4.1 | Diet and Fluid | 7.4.1 Diet and Fluid An overview of the diet/meal considerations relative to dosing, GEBT, and SmartPill are shown in [Table 7.b.](#page-34-0) Before each GEBT and/or SmartPill assessment in Part 1, subjects will be required to fast from 2300 the evening before and return to the CRU for witnessed doses on each subseque... | [] |
NCT03268941 | 7.4.2 | Activity | 7.4.2 Activity Subjects will avoid unaccustomed strenuous physical activity (eg, weight lifting, running, bicycling) from the Screening Visit until the Follow-up visit. | [] |
NCT03268941 | 7.5 | Criteria for Discontinuation or Withdrawal of a Subject | 7.5 Criteria for Discontinuation or Withdrawal of a Subject - 1. The subject experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the subject's health or the subject is unwilling to continue because of the AE. - 2. Liver Function Test (LFT) Abnormalities In m... | [] |
NCT03268941 | 7.6 | Procedures for Discontinuation or Withdrawal of a Subject | 7.6 Procedures for Discontinuation or Withdrawal of a Subject The investigator may discontinue a subject's trial participation at any time during the trial when the subject meets the trial termination criteria described in Section [7.5.](#page-35-0) In addition, a subject may discontinue his or her participation withou... | [] |
NCT03268941 | 7.7 | Subject Replacement | 7.7 Subject Replacement If a subject discontinues from the trial, a replacement subject may be enrolled, if deemed appropriate by the investigator and sponsor. The trial site should contact the sponsor for the replacement subject's treatment assignment and allocation number. | [] |
NCT03268941 | 8.0 | CLINICAL TRIAL MATERIAL MANAGEMENT | 8.0 CLINICAL TRIAL MATERIAL MANAGEMENT | [] |
NCT03268941 | 8.1 | Clinical Trial Drug | 8.1 Clinical Trial Drug | [] |
NCT03268941 | 8.1.1 | Trial Drugs | 8.1.1 Trial Drugs In this protocol, the term study medication refers to all or any of the drugs defined below. TAK-906 maleate capsules and matching placebo capsules for PO administration will be provided to the investigator by the sponsor. Details regarding the composition and extemporaneous preparation of the active ... | [] |
NCT03268941 | 8.1.1.1 | TAK-906 maleate | 8.1.1.1 TAK-906 maleate TAK-906 capsules, consists of TAK-906 maleate, nominally 5 or 25 mg in TAK-906 maleate per capsule, along with microcrystalline cellulose, National Formulary (NF) (PH102), sodium starch glycolate, NF and magnesium stearate, NF. All filled into size 3 hard gelatin capsule. All capsules have the s... | [] |
NCT03268941 | 8.1.1.2 | Placebo | 8.1.1.2 Placebo A matching placebo is identical to the TAK-906 maleate capsule presentations (ie, overencapsulation) except for an equal amount of microcrystalline cellulose NF in place of TAK-906 maleate. | [] |
NCT03268941 | 8.1.1.3 | Metoclopramide | 8.1.1.3 Metoclopramide Metoclopramide 10 mg will be administered according to product prescribing information [\[5\]](#page-71-5). | [] |
NCT03268941 | 8.1.2 | Use of Rescue Medication | 8.1.2 Use of Rescue Medication Subjects may take rescue medication for nausea under the following circumstance: During screening, subjects may receive up to 2 doses per day of antinausea medication (eg, ondansetron), but only after the subject has reported a nausea subscore ≥2. Similarly, antinausea medication may be u... | [] |
NCT03268941 | 8.1.3 | Clinical Study Drug Labeling | 8.1.3 Clinical Study Drug Labeling Clinical trial drug packaging will be affixed with a clinical label in accordance with regulatory requirements. | [] |
NCT03268941 | 8.1.4 | Clinical Study Drug Inventory and Storage | 8.1.4 Clinical Study Drug Inventory and Storage Clinical trial drug must be stored in a secure, limited-access location under the storage conditions specified on the label. Inventory (receipt and dispensing) of trial drug must be recorded by an authorized person at the trial site. | [] |
NCT03268941 | 8.1.5 | Clinical Study Drug Blinding | 8.1.5 Clinical Study Drug Blinding Part 1 is the double-blind portion of the trial. The trial drug blind is maintained through a randomization schedule held by authorized persons only. Part 2 is the open label portion of the trial; therefore, the sponsor, investigator, and subject will know the treatment administered. | [] |
NCT03268941 | 8.1.6 | Randomization Code Creation and Storage | 8.1.6 Randomization Code Creation and Storage Takeda Development Center Americas, Inc. Analytical Sciences Department or designee will generate the randomization schedule. Subject randomization will be stratified by the underlying condition, ie, DG versus IG. All randomization information will be stored in a secured ar... | [] |
NCT03268941 | 8.1.7 | Clinical Trial Blind Maintenance/Unblinding Procedure | 8.1.7 Clinical Trial Blind Maintenance/Unblinding Procedure
Part 1: The investigational drug blind is maintained through a randomization schedule held by authorized personnel only. The investigational drug blind shall not be broken by the investigator unless information concerning the investigational drug is necessary... | [
"Part 1:"
] |
NCT03268941 | 8.1.8 | Accountability and Destruction of Sponsor-Supplied Drugs | 8.1.8 Accountability and Destruction of Sponsor-Supplied Drugs The investigator is responsible for keeping accurate records of the clinical trial drug received from the sponsor or designee, the amount dispensed to and returned by the subjects, and the amount remaining at the conclusion of the trial. For all trial sites... | [] |
NCT03268941 | 8.1.9 | Ancillary Supplies | 8.1.9 Ancillary Supplies All ancillary supplies will be provided by either the site or Takeda, based upon availability. If provided by Takeda, unused ancillary supplies will be accounted for and disposed of as directed by Takeda or a Takeda designee. | [] |
NCT03268941 | 9.0 | TRIAL PROCEDURES | 9.0 TRIAL PROCEDURES The following sections describe the trial procedures and data to be collected as indicated in the Schedule of Trial Procedures (Section [3.0\)](#page-11-0). For each procedure, subjects are to be assessed by the same investigator or site personnel whenever possible. Please note that it may become n... | [] |
NCT03268941 | 9.1 | Administrative Procedures | 9.1 Administrative Procedures | [] |
NCT03268941 | 9.1.1 | Informed Consent Procedure | 9.1.1 Informed Consent Procedure Informed consent must be obtained before the subject entering into the trial and before any protocol-directed procedures are performed. The requirements of informed consent are described in Section [13.2.](#page-61-0) | [] |
NCT03268941 | 9.1.1.1 | Assignment of Screening and Randomization Numbers | 9.1.1.1 Assignment of Screening and Randomization Numbers
Parts 1 and 2: All consented subjects will be given a unique screening number that will be used to identify the subject for all procedures. Each subject will be assigned only 1 screening number. Screening numbers must not be re-used for different subjects. Any ... | [
"Parts 1 and 2:",
"Part 1:"
] |
NCT03268941 | 9.1.1.2 | Study Drug Assignment | 9.1.1.2 Study Drug Assignment On Day 1 of Part 1, subjects will be assigned a randomization number. The randomization number encodes the subject assignment to 1 of 3 active treatment arms or the placebo arm of the trial, according to the randomization schedule generated before the trial by the sponsor's Statistics Depa... | [] |
NCT03268941 | 9.1.2 | Inclusion and Exclusion | 9.1.2 Inclusion and Exclusion Each subject is assessed through randomization, according to the eligibility criteria provided in Section [7.0.](#page-27-0) | [] |
NCT03268941 | 9.1.3 | Medical History, Prior and Concomitant Medications, and Demographics | 9.1.3 Medical History, Prior and Concomitant Medications, and Demographics Qualified site personnel are to collect subject significant medical history (past and concurrent) per the site's standard of care and appropriate clinical judgment and subject demographics. Qualified site personnel are to review subject prior an... | [] |
NCT03268941 | 9.2 | Clinical Procedures and Assessments | 9.2 Clinical Procedures and Assessments | [] |
NCT03268941 | 9.2.1 | Physical Examinations | 9.2.1 Physical Examinations Qualified site personnel will conduct physical examinations. | [] |
NCT03268941 | 9.2.2 | Height and Weight | 9.2.2 Height and Weight Body weight and height will be obtained with the subject's shoes off and jacket or coat removed. | [] |
NCT03268941 | 9.2.3 | BMI | 9.2.3 BMI BMI equals a person's weight in kilograms divided by height in meters squared (BMI=kg/m2 ). BMI will be rounded to the nearest whole number according to the standard convention of 0.1 to 0.4 round down and 0.5 to 0.9 round up. | [] |
NCT03268941 | 9.2.4 | Vital Sign Measurement | 9.2.4 Vital Sign Measurement Body temperature will be measured with an oral (temperature taken at floor of the mouth) or tympanic thermometer. The same method (eg, oral or tympanic) must be used for all subsequent measurements for each individual subject and should be the same for all subjects. Subjects should rest in ... | [] |
NCT03268941 | 9.2.5 | 12-Lead ECG | 9.2.5 12-Lead ECG Special care must be taken for proper lead placement by qualified personnel. Skin should be clean and dry before lead placement. Subjects may need to be shaved to ensure proper lead placement. Women may need to remove their bra. Subjects should be resting in a semirecumbent position for at least 5 min... | [] |
NCT03268941 | 9.2.6 | Trial Drug Administration | 9.2.6 Trial Drug Administration For Part 1 of the trial subjects will be randomized on Day 1 into 1 of 3 active treatment arms (TAK-906 maleate 5, 25, or 100 mg BID) or a placebo arm to receive trial drug PO in a double-dummy manner for 9 consecutive days. For Part 2 of the trial, approximately 6 subjects who complete ... | [] |
NCT03268941 | 9.2.7 | AE Monitoring | 9.2.7 AE Monitoring AE monitoring begins following signing of informed consent and continues throughout the study. A complete description of AE collection and procedures is provided in Section [10.0.](#page-48-1) | [] |
NCT03268941 | 9.2.8 | Laboratory Procedures and Assessments | 9.2.8 Laboratory Procedures and Assessments Laboratory samples will be collected in accordance with acceptable laboratory procedures. Samples will be taken following a minimum 8-hour overnight fast on the days stipulated in the Schedule of Trial Procedures (Section [3.0\)](#page-11-0). The local laboratory will perform... | [] |
NCT03268941 | 9.2.8.1 | Clinical Laboratory Tests | 9.2.8.1 Clinical Laboratory Tests
Hematology Hematology will consist of the following tests: | Erythrocytes (red blood cells [RBCs]) | Hemoglobin | |------------------------------------------------------------------|------------| | Hematocrit | Platelets | | Leukocytes (white blood cells [WBCs]) with absolute differen... | [
"Hematology",
"Urinalysis",
"Chemistry"
] |
NCT03268941 | 9.2.8.2 | Diagnostic Screening | 9.2.8.2 Diagnostic Screening
Serum Serum diagnostic evaluations will include the following tests: | HIV | Hepatitis Screen (hepatitis A virus antibody, HBsAg,hepatitis C virus antibody) | |-----------------------------------------------|----------------------------------------------------------------------------------... | [
"Serum",
"Alcohol Screen",
"Urine"
] |
NCT03268941 | 9.2.9 | Symptom Assessments | 9.2.9 Symptom Assessments 9.2.9.1 Information . 9.2.9.2 Confidential 9.2.9.3  | [] |
NCT03268941 | 9.3 | PK, PD, and Pharmacogenetic Samples | 9.3 PK, PD, and Pharmacogenetic Samples Samples for PK, PD, and or other biomarker analysis will be collected as specified in the Schedule of Trial Procedures (Section [3.0\)](#page-11-0). Please refer to the Laboratory Manual for information on the collection, processing, and shipment of samples to the Central Laborat... | [] |
NCT03268941 | 9.3.1 | PK Measurements | 9.3.1 PK Measurements PK parameters will be derived using noncompartmental analysis methods and will be determined from the concentration-time data for all evaluable subjects. Actual sampling times, rather than scheduled sampling times, will be used in all PK computations involving sampling times for plasma PK paramete... | [] |
NCT03268941 | 9.3.1.1 | Plasma or Serum for PK Measurements | 9.3.1.1 Plasma or Serum for PK Measurements PK blood samples for plasma TAK-906 concentrations will be collected as specified in Parts 1 and 2 of the Schedule of Trial Procedures (See Section [3.0\)](#page-11-0). The collected blood samples may be archived for additional analysis of potential metabolites. | [] |
NCT03268941 | 9.3.2 | PD Measurements | 9.3.2 PD Measurements | [] |
NCT03268941 | 9.3.2.1 | Serum Samples for Pharmacodynamics | 9.3.2.1 Serum Samples for Pharmacodynamics Serum prolactin levels will be measured as a PD target engagement marker using an in vitro diagnostic assay (ADVIA Centaur Prolactin assay). | [] |
NCT03268941 | 9.3.2.2 | GEBT | 9.3.2.2 GEBT The GEBT test procedure should be administered under supervision of a health care professional although no specialized facilities or specially licensed personnel are required. | [] |
NCT03268941 | 9.3.2.3 | SmartPill Motility | 9.3.2.3 SmartPill Motility SmartPill is an ingestible capsule that measures pressure, pH and temperature as it travels through the GI tract to assess GE and GI motility and will be administered under supervision of a health care professional. | [] |
NCT03268941 | 9.3.3 | PGx | 9.3.3 PGx | [] |
NCT03268941 | 9.3.3.1 | Blood Sample for DNA PGx | 9.3.3.1 Blood Sample for DNA PGx When sampling of whole blood for PGx analysis occurs, every subject must sign an informed consent/be consented to participate in the trial. PGx is a component of the trial, participation in mandatory. PGx is the study of variations of deoxyribonucleic acid (DNA) characteristics as relat... | [] |
NCT03268941 | 9.4 | Confinement | 9.4 Confinement In Parts 1 and 2 of the study, the subject will be confined for approximately the first 8 hours following the first dose of medication to allow for intensive PK sampling and close glucose monitoring. At the discretion of the investigator, subjects may be requested to remain longer in the CRU. | [] |
NCT03268941 | 10.0 | ADVERSE EVENTS | 10.0 ADVERSE EVENTS | [] |
NCT03268941 | 10.1 | Definitions and Elements of AEs | 10.1 Definitions and Elements of AEs An AE is defined as any untoward medical occurrence in a clinical investigation subject who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sig... | [
"Pre-existing conditions:",
"Worsening of AEs:",
"Changes in severity of AEs:",
"Preplanned surgeries or procedures:",
"Elective surgeries or procedures:",
"Overdose:",
"CONFIDENTIAL"
] |
NCT03268941 | 10.1.1 | SAEs | 10.1.1 SAEs An SAE is defined as any untoward medical occurrence that at any dose: - 1. Results in DEATH. - 2. Is LIFE THREATENING. - The term "life threatening" refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused dea... | [] |
NCT03268941 | 10.2 | AE Procedures | 10.2 AE Procedures | [] |
NCT03268941 | 10.2.1 | Assigning Severity/Intensity of AEs | 10.2.1 Assigning Severity/Intensity of AEs The different categories of severity/intensity are: Mild: An AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate: An AE that is usually alleviate... | [] |
NCT03268941 | 10.2.2 | Assigning Causality of AEs | 10.2.2 Assigning Causality of AEs The relationship of each AE to study medication(s) will be assessed using the following categories: Related: An AE that follows a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which a causal relationship is at lea... | [] |
NCT03268941 | 10.2.3 | Start Date | 10.2.3 Start Date The start date of the AE is the date that the first signs/symptoms were noted by the subject and/or investigator. | [] |
NCT03268941 | 10.2.4 | End Date | 10.2.4 End Date The end date of the AE is the date at which the subject recovered, the event resolved but with sequelae or the subject died. | [] |
NCT03268941 | 10.2.5 | Pattern of AE (Frequency) | 10.2.5 Pattern of AE (Frequency) Episodic AEs (eg, headache) or those which occur repeatedly over a period of consecutive days are intermittent. All other events are continuous. | [] |
NCT03268941 | 10.2.6 | Action Taken With Study Treatment | 10.2.6 Action Taken With Study Treatment - Drug withdrawn a study medication is stopped due to the particular AE. - Dose not changed the particular AE did not require stopping a study medication. - Unknown only to be used if it has not been possible to determine what action has been taken. - Not applicable a study medi... | [] |
NCT03268941 | 10.2.7 | Outcome | 10.2.7 Outcome Recovered/resolved – subject returned to first assessment status with respect to the AE. - Recovering/resolving the intensity is lowered by one or more stages: the diagnosis has or signs/symptoms have almost disappeared; the abnormal laboratory value improved, but has not returned to the normal range or ... | [] |
NCT03268941 | 10.2.8 | Collection and Reporting of AEs, SAEs, and Abnormal LFTs | 10.2.8 Collection and Reporting of AEs, SAEs, and Abnormal LFTs | [] |
NCT03268941 | 10.2.8.1 | Collection Period | 10.2.8.1 Collection Period Collection of AEs (ie, AEs, SAEs, abnormal LFTs, and other laboratory abnormalities) will commence at the time the subject signs the informed consent. Routine collection of AEs will continue until 14 days after the last dose of investigational product. For subjects who discontinue prior to th... | [] |
NCT03268941 | 10.2.8.2 | Reporting AEs | 10.2.8.2 Reporting AEs At each study visit, the investigator will assess whether any subjective AEs have occurred. A neutral question, such as "How have you been feeling since your last visit?" may be asked. Subjects may report AEs occurring at any other time during the study. Subjects experiencing an SAE prior to the ... | [] |
NCT03268941 | 10.2.8.3 | Reporting SAEs | 10.2.8.3 Reporting SAEs When an SAE occurs through the AE collection period it should be reported according to the procedure outlined below: A Takeda SAE form must be completed, in English and signed by the investigator immediately or within 24 hours of first onset or notification of the event. The information should b... | [
"SAE Follow-Up"
] |
NCT03268941 | 10.2.8.4 | Reporting of Abnormal LFTs | 10.2.8.4 Reporting of Abnormal LFTs If a subject is noted to have ALT or AST elevated >3 ×ULN on 2 consecutive occasions, the abnormality should be recorded as an AE. In addition, an LFT Increases eCRF must be completed providing additional information on relevant recent history, risk factors, clinical signs and sympto... | [] |
NCT03268941 | 10.2.9 | Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities | 10.2.9 Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities The Sponsor will be responsible for reporting all suspected unexpected serious adverse reactions (SUSARs) and any other applicable SAEs to regulatory authorities, investigators and IRBs or IECs, as applicable, in accordance with national... | [] |
NCT03268941 | 11.0 | STATISTICAL METHODS | 11.0 STATISTICAL METHODS | [] |
NCT03268941 | 11.1 | Statistical and Analytical Plans | 11.1 Statistical and Analytical Plans A statistical analysis plan (SAP) will be prepared and finalized before database lock. This document will provide further details regarding the definition of analysis variables and analysis methodology to address all trial objectives. A targeted data review will be conducted before... | [] |
NCT03268941 | 11.1.1 | Analysis Sets | 11.1.1 Analysis Sets | [] |
NCT03268941 | 11.1.1.1 | Safety Set | 11.1.1.1 Safety Set The safety set will consist of all subjects who are enrolled and receive at least 1 dose of trial drug. Subjects in this analysis set will be used for demographic, baseline characteristics, and safety summaries. | [] |
NCT03268941 | 11.1.1.2 | PK Set | 11.1.1.2 PK Set The PK set will consist of all subjects who are enrolled and receive at least 1 dose of trial drug and have at least 1 measurable plasma TAK-906 concentration. All subjects with valid PK parameter estimates will be included in the summaries and analyses for that parameter. If any subject is found to be ... | [] |
NCT03268941 | 11.1.1.3 | PD Set | 11.1.1.3 PD Set The PD set for each PD measurement will consist of all subjects who are enrolled, receive at least 1 dose of study drug, have a baseline value, and have at least 1 valid postbaseline value for assessment of the PD measurement. | [] |
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