protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT01970982 | 5.1.3 | Removal of Subjects from the Study | 5.1.3 Removal of Subjects from the Study Subjects will be informed that they are free to withdraw from the study at any time. Subjects should be questioned for the reason of premature withdrawal, although they are not obliged to disclose it. This needs to be fully documented in the Source Document and electronic Case R... | [] |
NCT01970982 | 5.1.4 | Violation of Selection Criteria | 5.1.4 Violation of Selection Criteria Subjects who are eligible at Screening, but who do not meet the entry criteria at Admission Day (Day -2) will be considered a screening failure and will be replaced by other subjects. Subjects who violate the entry criteria prior to enrolment, but who were considered eligible, will... | [] |
NCT01970982 | 6 | INVESTIGATIONAL PRODUCTS | 6 INVESTIGATIONAL PRODUCTS | [] |
NCT01970982 | 6.1 | Description of Investigational Products | 6.1 Description of Investigational Products | [] |
NCT01970982 | 6.1.1 | Test Product | 6.1.1 Test Product THS 2.2 comprises the following components: Tobacco Stick, Holder, Charger, a Cleaning Tool, a mains power supply, and a USB cable: | ZRHR-REXC-04-JP | Clinical Study Protocol | Confidential | |---------------------------------------|-------------------------------------------------------------------... | [] |
NCT01970982 | 6.1.2 | Reference Product / Baseline Period Products | 6.1.2 Reference Product / Baseline Period Products During the run-in period (Admission to clinic until 06:29 AM of Day -1) and the baseline period (from 06:30 AM of Day -1 until 06:29 AM of Day 1), all subjects will continue smoking their preferred commercially available single brand of non-menthol CC. Subjects are not... | [] |
NCT01970982 | 6.1.3 | Packaging and Labeling | 6.1.3 Packaging and Labeling At Admission, all study subjects will provide the anticipated amount of CC in sealed packs to the study site collaborator. The CC packs provided by the subjects should not be opened and the cellophane wrapper should be intact. Each pack of CC provided by the subject will be labeled to ident... | [] |
NCT01970982 | 6.2 | Use of Investigational Product | 6.2 Use of Investigational Product Subjects will never be requested or forced to smoke and will be free to stop smoking at any time during the study. The study is designed as an ad libitum use study. During the confinement period, smoking will generally be allowed between 06:30 AM to 11:00 PM. During the screening peri... | [] |
NCT01970982 | 6.2.1 | Run-in Period | 6.2.1 Run-in Period Smoking ad libitum will be allowed prior to admission and throughout the day except during the procedures. All subjects will be allowed to continue smoking ad libitum their single preferred brand of usual CC. All subjects (except women with a positive pregnancy test at Screening or at Admission) wil... | [] |
NCT01970982 | 6.2.2 | Baseline Period | 6.2.2 Baseline Period During the baseline period, all subjects will be allowed to continue smoking ad libitum their single preferred usual brand of non-menthol CC. | [] |
NCT01970982 | 6.2.3 | Exposure Period | 6.2.3 Exposure Period Subjects are not allowed to smoke any CC or use any nicotine/tobacco-containing products other than the product/regimen. | [] |
NCT01970982 | 6.2.3.1 | THS 2.2 Arm | 6.2.3.1 THS 2.2 Arm Subjects randomized to the THS 2.2 arm will use exclusively THS 2.2 from Day 1, 06:30 AM onwards until Day 5, 11:00 PM. | [] |
NCT01970982 | 6.2.3.2 | Conventional Cigarettes Arm | 6.2.3.2 Conventional Cigarettes Arm Subjects randomized to the CC arm will continue smoking their CC from Day 1, 06:30 AM onwards until Day 5, 11:00 PM. | [] |
NCT01970982 | 6.2.3.3 | Smoking Abstinence Arm | 6.2.3.3 Smoking Abstinence Arm Subjects randomized to the SA study arm will be instructed to abstain from smoking from Day 1, 06:30 AM onwards until Day 5, 11:00 PM. They will not be provided with medication supportive for smoking abstinence. | [] |
NCT01970982 | 6.2.4 | Stopping Rules for Investigational Product | 6.2.4 Stopping Rules for Investigational Product For safety purposes, smoking should be temporarily stopped in the event of any signs suggesting nicotine overexposure, (e.g., gastrointestinal disturbance [nausea, vomiting, diarrhea, stomach or abdominal pain], cold sweats, headache, dizziness, and breathing problems) o... | [] |
NCT01970982 | 6.2.5 | Safety Follow-up Period | 6.2.5 Safety Follow-up Period During the safety follow-up period (after the Time of Discharge at Day 6 until Day 13), all subjects are free to smoke their own CC ad libitum. Subjects in the SA arm, who wish to continue their SA, or any subject who wish to stop smoking will be referred for further treatment as per the s... | [] |
NCT01970982 | 6.3 | Method for Assigning Subjects to Study Arms | 6.3 Method for Assigning Subjects to Study Arms When all the eligibility criteria have been met, randomization will be done through the Interactive Web and Voice Response System (IWRS) on Day 0 at any time during the day. Subjects will be informed of their randomized study arm in the morning of Day 1, prior to 06:30 AM... | [] |
NCT01970982 | 6.4 | Blinding | 6.4 Blinding This is an open-label study; therefore, the subjects and Investigators will be unblinded to the subject's arm. However, there will be a limited degree of blinding in the data review and data analysis process. In particular, PMI and CRO personnel will be blinded to the randomized arm as summarized in the fo... | [] |
NCT01970982 | 6.5 | Investigational Product Accountability and Compliance | 6.5 Investigational Product Accountability and Compliance | [] |
NCT01970982 | 6.5.1 | Dispensing Investigational Product | 6.5.1 Dispensing Investigational Product From Day-2 onwards, each CC will be dispensed to the subjects. Subjects in the THS 2.2 arm will be provided by the site personnel with Tobacco Sticks from Day 1 to Day 5. One cigarette/tobacco stick will be allowed at a time, as per the study design, and documented in an appropr... | [] |
NCT01970982 | 6.5.2 | Storage and Accountability | 6.5.2 Storage and Accountability The study collaborator (the investigational product storage manager) designated by the head of the investigational site will be responsible for the storage and accountability of the investigational products. The THS 2.2 and CC will be stored in a secured storage site with access limited... | [] |
NCT01970982 | 6.5.3 | Investigational Product Retention | 6.5.3 Investigational Product Retention The study site will destroy or return to the Sponsor any unused Tobacco Sticks and will return to the Sponsor the THS 2.2 product components upon study completion. Retention of THS 2.2 products will be documented. Irrespective of the study arm on the time of Discharge from the cl... | [] |
NCT01970982 | 6.5.4 | Compliance to Investigational Product(s) | 6.5.4 Compliance to Investigational Product(s) Compliance for all study arms will be ensured by strict distribution of the products (product by product) and collection of used Tobacco Sticks, the CC butts will be documented in appropriate log. In addition, in the SA arm, compliance will be chemically verified using an ... | [] |
NCT01970982 | 6.6 | Restrictions | 6.6 Restrictions | [] |
NCT01970982 | 6.6.1 | Smoking Restrictions and Restrictions to the Smoking Abstinence Arm | 6.6.1 Smoking Restrictions and Restrictions to the Smoking Abstinence Arm To avoid cross contamination between the 3 study arms, subjects must use THS 2.2 and CC must in separate rooms and subjects allocated to the SA arm should not have access to the smoking rooms. All precautions should be taken to remove any temptat... | [] |
NCT01970982 | 6.6.2 | Dietary Restrictions | 6.6.2 Dietary Restrictions A standard diet will be designed by a dietician for the whole confinement period. For each meal, the caloric and fat content should be controlled in order to avoid "high-fat" diet. The FDA guidance on food-effect studies for bioequivalency testing identifies a "high-fat"diet as a diet which m... | [] |
NCT01970982 | 6.7 | Concomitant Medications | 6.7 Concomitant Medications No medication should be taken during the study from the Screening to the EOS (time of discharge plus 7-day safety follow-up period) without prior informing the Investigator. However, the Principal Investigator is responsible for the medical care of the subjects during their participation in ... | [
"ZRHR-REXC-04-JP Clinical Study Protocol Confidential Final 2.0/08 July 2013 Page 67 of 171"
] |
NCT01970982 | 7 | STUDY PROCEDURES | 7 STUDY PROCEDURES Personnel performing study measurements or recordings must have the appropriate training fully documented. Quality and control measures have to be in place. An overview of all study procedures is shown in the Schedule of Events [\(Appendix 1\)](#page-154-0). In this Section, only the expected/planned... | [] |
NCT01970982 | 7.1 | Informed Consent/Subject Information Sheet | 7.1 Informed Consent/Subject Information Sheet Prior any study assessments is performed, the subject will be asked to provide his consent to participate to the study (ICF for study participation) Section [1.3.](#page-27-1) In addition to the ICF for study participation, the subject will be asked to provide his separate... | [] |
NCT01970982 | 7.2 | Advice on the Risk of Smoking and Debriefing | 7.2 Advice on the Risk of Smoking and Debriefing may be publicly disclosed without the written consent of Philip Morris Products S.A. Confidentiality statement: Data and information contained in this document are considered to constitute trade secrets and confidential commercial information, and the legal protections p... | [] |
NCT01970982 | 7.3 | Support for the Smoking Abstinence Arm | 7.3 Support for the Smoking Abstinence Arm All subjects in the SA arm will be closely monitored by the site study collaborator for possible signs and symptoms of nicotine withdrawal. This includes clinical monitoring, e.g. vital signs, physical examination and body weight. It will also involve close monitoring of the s... | [] |
NCT01970982 | 7.4 | Clinical Assessments | 7.4 Clinical Assessments Any clinically relevant finding detected during the Screening Visit has to be documented as a concomitant disease. This also applies to clinically relevant findings in e.g. laboratory values, vital signs and ECGs, detected during the Screening Visit. Any untoward medical occurrence in a subject... | [] |
NCT01970982 | 7.4.1 | Demographic Data | 7.4.1 Demographic Data Demographic data (sex, date of birth/age) will be recorded at the Screening Visit. | [] |
NCT01970982 | 7.4.2 | Identification of the Current Cigarette Brand | 7.4.2 Identification of the Current Cigarette Brand Identification of the current CC brand(s) smoked by the subject will be done at the Screening Visit and at Day -2. At the Screening Visit, smokers will be asked to bring a pack of their current CC brand(s) to the site. On Day -2, subjects will hand their CC supply for... | [] |
NCT01970982 | 7.4.3 | Smoking History and Willingness to Quit Smoking | 7.4.3 Smoking History and Willingness to Quit Smoking Subjects will be asked about their smoking history. At Screening and on the Day of Admission (Day -2) this will include questions to evaluate whether the subject has smoked for at least the last 3 consecutive years, to determine the number of CC smoked during the pr... | [] |
NCT01970982 | 7.4.4 | Demonstration and Trial of the THS 2.2 | 7.4.4 Demonstration and Trial of the THS 2.2 All subjects will have a demonstration of the THS 2.2 product at the Screening Visit. On Day -2, as the last procedure of the eligibility assessments on that day, subjects will have a trial of the THS 2.2 product (use of up to three THS Tobacco Sticks). In female subjects, t... | [] |
NCT01970982 | 7.4.5 | Medical History, Concomitant Diseases, Previous and Ongoing Medications | 7.4.5 Medical History, Concomitant Diseases, Previous and Ongoing Medications Relevant medical history will be documented at the Screening Visit. Any concomitant disease will be documented at the Screening Visit. Medical history is defined as any condition that started prior to and ended prior to Screening. A concomita... | [] |
NCT01970982 | 7.4.6 | Physical Examination | 7.4.6 Physical Examination A physical examination will be conducted at the Screening Visit, at Admission (Day -2), and at Day 6. Appropriate medical advice will be provided to the subject in case of any medical findings requiring health care. Final 2.0/08 July 2013 Page 73 of 171 | [] |
NCT01970982 | 7.4.7 | Body Height and Weight | 7.4.7 Body Height and Weight Body weight will be recorded at all time-points at the Screening Visit, at Admission (Day - 2), and at Discharge on Day 6. Body height will be measured only at the Screening Visit. Body mass index will be calculated from the body weight and height using the following formula: weight in kilo... | [] |
NCT01970982 | 7.4.8 | Vital signs | 7.4.8 Vital signs Systolic and diastolic blood pressure, pulse rate and respiratory rate will be measured at the Screening Visit, at Admission (Day -2), and in the morning of every day of the confinement period (i.e. Days -1 to 6). All measurements will be made after the subject has rested for at least 5 minutes in a s... | [] |
NCT01970982 | 7.4.9 | Other Clinical Assessments | 7.4.9 Other Clinical Assessments | [] |
NCT01970982 | 7.4.9.1 | Spirometry | 7.4.9.1 Spirometry Spirometry with and without a short-acting bronchodilator will be done at the Screening Visit to evaluate inclusion/exclusion criteria (the post-bronchodilator results). At screening, spirometry without bronchodilator will be done first, and then, spirometry with bronchodilator. Furthermore, spiromet... | [] |
NCT01970982 | 7.4.9.2 | Electrocardiogram | 7.4.9.2 Electrocardiogram An ECG will be recorded at Screening, and at Day 6. Electrocardiogram testing will be performed as per the site's local practice. A standard 12-lead ECG will be recorded after the subject has rested for at least 10 minutes in a supine position. The following parameters will be documented: hear... | [] |
NCT01970982 | 7.4.9.3 | Chest X ray | 7.4.9.3 Chest X ray A chest X-ray (anterior-posterior and left lateral views) will be assessed during the Screening period to exclude subjects with relevant pulmonary diseases. Subjects will be referred to a radiology facility for this procedure. No new examination is required if the subject can present a chest X-ray w... | [] |
NCT01970982 | 7.5 | Biomarker Assessment | 7.5 Biomarker Assessment All bioanalytical assays and laboratory assessments will be carried out using validated methods (see Sections [7.6](#page-78-0) and [7.7\)](#page-80-0). The bioanalytical methods used will be documented in the Bioanalytical Plans/Reports. A list of laboratories is provided in [Appendix 2.](#pag... | [] |
NCT01970982 | 7.5.1 | Biomarker of Exposure | 7.5.1 Biomarker of Exposure | [] |
NCT01970982 | 7.5.1.1 | Exhaled CO and Carboxyhemoglobin | 7.5.1.1 Exhaled CO and Carboxyhemoglobin Carboxyhemoglobin measured in blood and exhaled CO will be investigated as a measure of CO in all three study arms. The CO breath test should be conducted in timely conjunction with the blood sampling for COHb, where applicable. In the SA arm, the CO breath test will serve as a ... | [
"CO Breath Test",
"Carboxyhemoglobin"
] |
NCT01970982 | 7.5.1.2 | Plasma Nicotine and Cotinine | 7.5.1.2 Plasma Nicotine and Cotinine Nicotine and cotinine concentrations will be measured in plasma to evaluate the exposure to nicotine. For subjects in the SA arm, blood samples will be collected on Days 0 to 4, at comparable time points. No nicotine PK profile will be done for subjects in the SA arm on Day 5 and Da... | [] |
NCT01970982 | 7.5.1.3 | Other Biomarkers of Exposure | 7.5.1.3 Other Biomarkers of Exposure The following BoExp will be measured in 24-hour urine collection samples as per the Schedule of Events (see also [Appendix 1\)](#page-154-0): - Primary BoExp: MHBMA, 3-HPMA, S-PMA. - Secondary BoExp: total NNAL, 1-NA, total 1-OHP, total NNN, 3 hydroxy(a)benzopyrene, 4-ABP, 2-NA, o-t... | [] |
NCT01970982 | 7.5.2 | Other assessments | 7.5.2 Other assessments | [] |
NCT01970982 | 7.5.2.1 | Risk markers | 7.5.2.1 Risk markers The following risk markers will be recorded/measured at the following time points: - 8-epi-PGF2α to be measured in 24-hour urine on Day 0 and Day 5. - 11-DTX-B2 to be measured in 24-hour urine on Day 0 and Day 5. | [] |
NCT01970982 | 7.5.2.2 | CYP1A2 activity test | 7.5.2.2 CYP1A2 activity test CYP1A2 activity will be measured at Day 0, and at Day 5. Measurement of enzyme activity will be assessed through paraxanthine (PX) and caffeine (CAF) plasma molar concentrations approximately 6 hours (±15 minutes) after the intake of one Tomerumin® [\(LionCorp.\)](#page-149-3) caffeine tabl... | [] |
NCT01970982 | 7.5.2.3 | CYP2A6 activity | 7.5.2.3 CYP2A6 activity CYP2A6 activity will be measured in plasma on Day 0, and at Day 6, using the metabolic molar ratio of trans-3'-hydroxycotinine/cotinine [\(Jacob et al., 2011\)](#page-149-4). Blood sampling for CYP2A6 activity will be done prior to product use. CYP2A6 activity drives the hepatic metabolism of ni... | [] |
NCT01970982 | 7.5.2.4 | Ames Mutagenicity Test | 7.5.2.4 Ames Mutagenicity Test Urine mutagenicity, a biomarker for measuring mutagen load, will be measured on Day 0 and on Day 5 in 24-hour urine. The urinary determination of each sample will be done in one bacterial strain (S. typhimurium strain YG1024), using S9 metabolic activation and 4 doses for each of the urin... | [] |
NCT01970982 | 7.6 | Laboratory Assessments | 7.6 Laboratory Assessments | [] |
NCT01970982 | 7.6.1 | Clinical Chemistry, Hematology, and Urine Analysis for Safety Panel | 7.6.1 Clinical Chemistry, Hematology, and Urine Analysis for Safety Panel Hematology, clinical chemistry and urine analysis for the safety panel will be measured at Screening, Day 0, and at Day 6. Blood samples will be taken after at least 10 hours of fasting (see Section [6.6.2\)](#page-64-1). The urine test will be p... | [] |
NCT01970982 | 7.6.2 | Serology | 7.6.2 Serology A test for HbsAg, HCV, and anti-HIV1/2 and p24 antigen will be done at Screening. In case of positive results, the subject will be referred to appropriate medical care. | [] |
NCT01970982 | 7.6.3 | Urine Drug Screen | 7.6.3 Urine Drug Screen A urine drug screen will be performed at the study site at the Screening Visit and on the day of Admission (Day -2). The urine will be screened for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates. | [] |
NCT01970982 | 7.6.4 | Urine Cotinine Screening | 7.6.4 Urine Cotinine Screening A urine cotinine test will be performed at Screening and at Admission to the clinic (Day -2) in order to confirm the subject's smoking status. The test must detect cotinine with a cotinine threshold of ≥200 ng/mL. | [] |
NCT01970982 | 7.6.5 | Alcohol Breath Test | 7.6.5 Alcohol Breath Test Subjects will have a breath alcohol test at the Screening Visit and at Admission to the clinic (Day -2) using an alcometer device. | [] |
NCT01970982 | 7.6.6 | Urine Pregnancy Testing | 7.6.6 Urine Pregnancy Testing All female subjects will undergo pregnancy testing at the Screening Visit, at Admission (Day -2), at Day 6. Female subjects with a positive pregnancy test at the Screening Visit or at Day -2 cannot be enrolled and will be considered a screening failure. The product test at Admission must b... | [] |
NCT01970982 | 7.7 | Sampling Handling and Storage | 7.7 Sampling Handling and Storage All blood samples are to be tested at a central laboratory with the exception of COHb blood sample and the safety laboratory panel which will be tested at a local laboratory (see [Appendix 2\)](#page-160-0). The urine cotinine test, urine pregnancy tests and urine drug screen will be d... | [] |
NCT01970982 | 7.7.1 | Blood samples | 7.7.1 Blood samples Blood samples will be collected by qualified and trained site personnel. Subjects should be in a seated position during blood collection. The maximal total volume of blood drawn for each subject will be around 170 ml, which includes 30 ml for safety and repeated analysis, 20 ml of blood for long-ter... | [] |
NCT01970982 | 7.7.2 | Urine samples | 7.7.2 Urine samples Spot urine samples will be used for the urine drug screen, urine cotinine screen, urine pregnancy tests, and safety urinalysis. For the 24-hour urine collection, subjects will empty their bladders shortly before 06:30 AM on the study day indicated in the Schedule of Events [\(Appendix 1,](#page-154-... | [] |
NCT01970982 | 7.7.3 | Bio-banking Long Term Storage of Blood and Urine | 7.7.3 Bio-banking Long Term Storage of Blood and Urine If a subject gives consent for sample bio-banking for BoExp/risk markers, additional samples of urine (from the 24 hour urine collection) and serum/plasma (20 ml of blood total) will be collected. - Samples from the 24-hour urine will be collected from the urine co... | [] |
NCT01970982 | 7.8 | Other Study Procedures | 7.8 Other Study Procedures | [] |
NCT01970982 | 7.8.1 | Human Smoking Topography Assessment | 7.8.1 Human Smoking Topography Assessment Human smoking topography (HST) involves the measurement of each smoker's unique way of smoking CCs or using THS Tobacco Sticks using the HST SODIM® device. The HST SODIM® device, model SPA/M (SODIM® Instrumentation, Fleury les Aubrais, France) is a device which is used to measu... | [] |
NCT01970982 | 7.8.1.1 | Human Smoking Topography Parameters: | 7.8.1.1 Human Smoking Topography Parameters: The HST SODIM® device measures and records the flow and other per-puff parameters listed in [Table 4](#page-84-0) below. From the per-puff parameters [\(Table 4\)](#page-84-0), the per cigarette parameters shown in [Table 5](#page-84-1) will be derived (representing average ... | [] |
NCT01970982 | 7.8.2 | Visual Inspection of Tobacco Plugs | 7.8.2 Visual Inspection of Tobacco Plugs All tobacco plugs collected during the study will be sent to the Sponsor for subsequent visual inspection to determine whether combustion occurred during product use. | [] |
NCT01970982 | 7.8.3 | Questionnaires | 7.8.3 Questionnaires The subject questionnaires and the VAS will be entered by the subject directly in the electronic patient reported outcomes device, or on paper copy. The questionnaires and the VAS will be reviewed for completeness by the study site study collaborator and subjects will be requested to complete any m... | [] |
NCT01970982 | 7.8.3.1 | Fagerström Test for Nicotine Dependence (revised version) | 7.8.3.1 Fagerström Test for Nicotine Dependence (revised version) Potential nicotine dependence will be assessed via a questionnaire at Screening using the Fagerström Test for Nicotine Dependence (FTND) [\(Fagerström et al., 2012\)](#page-145-2). The questionnaire consists of 6 questions which will be answered by the s... | [] |
NCT01970982 | 7.8.3.2 | Assessment of Cough | 7.8.3.2 Assessment of Cough Subjects will be asked to assess the respiratory symptom 'cough' on a VAS, on 3 Likert scales, and with an open question on a daily basis during the confinement period from Day 0 to Day 6. On each day, cough assessment has to be done prior to product use but no later than10: 00 AM. Subjects ... | [] |
NCT01970982 | 7.8.3.3 | Modified Cigarette Evaluation Questionnaire | 7.8.3.3 Modified Cigarette Evaluation Questionnaire Product evaluation will be assessed using the Modified Cigarette Evaluation Questionnaire (MCEQ; [Cappelleri et al., 2007\)](#page-144-5). The MCEQ assesses the degree to which subjects experience the reinforcing effects of smoking, by measuring: - Smoking satisfactio... | [] |
NCT01970982 | 7.8.3.4 | Questionnaire of Smoking Urges (QSU-brief) | 7.8.3.4 Questionnaire of Smoking Urges (QSU-brief) To assess the urge-to-smoke, all subjects will be asked to fill-in a 10-item brief version of the Questionnaire of Smoking Urges (QSU-brief; [Cox et al., 2001\)](#page-145-3). The QSU-brief is a self- reported questionnaire with 10 items to be rated on a 7-point scale,... | [] |
NCT01970982 | 7.8.3.5 | Minnesota Nicotine Withdrawal Scale (revised version) | 7.8.3.5 Minnesota Nicotine Withdrawal Scale (revised version) The MNWS is a valid and reliable scale that has been used previously to examine signs and symptoms of withdrawal from cigarette smoking [\(Hughes and Hatsukami, 1986;](#page-147-4) [Hughes and](#page-148-3) [Hatsukami, 2008\)](#page-148-3). It consists of tw... | [] |
NCT01970982 | 7.8.3.6 | Human Smoking Topography Questionnaire | 7.8.3.6 Human Smoking Topography Questionnaire A specific questionnaire, used for exploratory purposes, has been developed by PMI to evaluate the impact of the utilization of the HST SODIM® device on smoker's smoking/inhalation experience in terms of ritual disruption. This is a questionnaire with 5 items to be rated o... | [] |
NCT01970982 | 8 | ADVERSE EVENTS | 8 ADVERSE EVENTS | [] |
NCT01970982 | 8.1 | Definitions | 8.1 Definitions | [] |
NCT01970982 | 8.1.1 | Adverse Events | 8.1.1 Adverse Events The FDA MRTP guidelines specify the following definition for adverse events for tobacco products: an AE is any health-related event associated with the use of tobacco product in humans, which is adverse or unfavorable, whether or not it is considered related to the tobacco product, as defined by th... | [] |
NCT01970982 | 8.1.2 | Serious Adverse Events | 8.1.2 Serious Adverse Events An SAE is defined as, but not limited to, any untoward medical occurrence that: - Results in death. - Is life-threatening. - Requires inpatient hospitalization or prolongation of existing hospitalization. - Results in persistent or significant disability/incapacity, or - Is a congenital ano... | [] |
NCT01970982 | 8.2 | Assessment of Adverse Events | 8.2 Assessment of Adverse Events The Investigator is responsible for obtaining, assessing and documenting all AEs during the study. | [] |
NCT01970982 | 8.2.1 | Collection of Information | 8.2.1 Collection of Information Adverse event information will be collected from the time of signature of the ICF onwards until End of Study (EOS) either by the Investigator via spontaneous reporting or by the use of consistent, open, non-directive questions from study site study collaborator (e.g. "Have you had any he... | [] |
NCT01970982 | 8.2.2 | Period of Collection | 8.2.2 Period of Collection From the signature of the ICF onwards until EOS, all AEs (includes SAEs) will be collected by the Investigators and study collaborator as described below. | [] |
NCT01970982 | 8.2.3 | Screening Period | 8.2.3 Screening Period All existing health conditions identified during the Screening period will be recorded as concomitant disease and the subject's eligibility for admission to the study will be reviewed. Any AEs which occur during the screening period will be captured by the study site staff and assessed by the Inv... | [] |
NCT01970982 | 8.2.4 | Admission Day until the End of Study | 8.2.4 Admission Day until the End of Study From Admission onwards until Day of Discharge, all AEs will be actively collected by the study site staff. Any new, clinically relevant, abnormal finding or worsening of a pre-existing condition/concomitant disease detected during the study will be documented as an AE and/or S... | [] |
NCT01970982 | 8.2.5 | Intensity of Adverse Event | 8.2.5 Intensity of Adverse Event For each AE, the intensity will be graded by the Investigator on a 3-point intensity scale (mild, moderate, severe) using the following definitions: Mild: The AE is easily tolerated and does not interfere with activities of daily living (ADL). Moderate: The AE interferes with ADL, but t... | [] |
NCT01970982 | 8.2.6 | Relationship to Investigational Product and Relationship to Study Procedures | 8.2.6 Relationship to Investigational Product and Relationship to Study Procedures According to the Council for International Organizations of Medical Sciences VI Working Group, there are no definitive methods for distinguishing most adverse drug reactions (i.e., events that are causally attributed to the IP) from clin... | [] |
NCT01970982 | 8.2.7 | Expectedness | 8.2.7 Expectedness An AE will be regarded as 'unexpected' if its nature or severity is not consistent with information already known about the IP, and/or has not been previously observed and is not listed in the current IB. The IB provides further detail on signs or symptoms that might be expected with the use of the I... | [] |
NCT01970982 | 8.3 | Reporting of Serious Adverse Events | 8.3 Reporting of Serious Adverse Events Any SAEs reported or observed during the study after signature of the ICF until the end of the safety follow-up period (i.e. up to 7 days after study Discharge), whether or not attributable to the IP, to any other medication or to any study procedures, must be reported by the Pri... | [] |
NCT01970982 | 8.4 | Reporting of Other Events Critical to Safety Evaluations | 8.4 Reporting of Other Events Critical to Safety Evaluations | [] |
NCT01970982 | 8.4.1 | Abnormal Results of Laboratory Tests | 8.4.1 Abnormal Results of Laboratory Tests Any clinical safety laboratory test result that is outside of the normal reference range will be reviewed by the Investigator and assessed for clinical relevance. If the Investigator considers the abnormal result to be of clinical relevance, then it must be recorded as a conco... | [] |
NCT01970982 | 8.4.2 | Abnormal Results of Other Tests or Investigations | 8.4.2 Abnormal Results of Other Tests or Investigations An ongoing medical condition or clinically relevant finding detected during the Screening Visit (including elevated laboratory parameters), will be considered a concomitant disease and the subject's eligibility for admission to the study will be reviewed. Any new,... | [] |
NCT01970982 | 8.5 | Reporting and Follow-Up of Pregnancies | 8.5 Reporting and Follow-Up of Pregnancies For pregnancies detected during the Screening period and prior to first THS 2.2 use, the subject will be considered as a screening failure and removed from the study. No Pregnancy Form will be filled; however, the diagnosed pregnancy must be captured in the Screen Failure eCRF... | [] |
NCT01970982 | 8.6 | Adverse Events Leading to Withdrawal | 8.6 Adverse Events Leading to Withdrawal Subjects who are withdrawn from the study because of an AE will undergo the procedures, as described for the Day of Discharge, as soon as possible and will enter the period of safety follow-up. The Investigator will follow-up these AEs until they have resolved, stabilized (i.e.,... | [] |
NCT01970982 | 8.7 | Investigational Device Misuse | 8.7 Investigational Device Misuse Any occurrences of the THS Tobacco Stick Holder or THS Charger misuse (use not in accordance with its label and instruction) by a subject, will be documented by the Investigator or his/her designated study collaborator using a Device Issue Log. Investigational device misuse may result ... | [] |
NCT01970982 | 8.8 | Investigational Device Malfunction | 8.8 Investigational Device Malfunction Any occurrences of malfunction of the Tobacco Stick Holder or Charger will be documented by the Investigator or his/her designated study collaborator using a Device Issue Log. ZRHR-REXC-04-JP Clinical Study Protocol Confidential Final 2.0/08 July 2013 Page 100 of 171 Furthermore, ... | [] |
NCT01970982 | 9 | STUDY ACTIVITIES | 9 STUDY ACTIVITIES A detailed schedule of assessment can be found in [Appendix 1.](#page-154-0) The time points shown are to be considered the time of assessment for the first subject. As not all subjects can be treated at the same time, a short time window will be implemented for subsequent subjects. Measurements not ... | [] |
NCT01970982 | 9.1 | Screening Visit | 9.1 Screening Visit The screening Visit will be performed within 4 weeks (Day -30 to Day -3) prior to admission (Day -2). Subjects will attend the investigational site in at least 10-hour fasting state for clinical laboratory to be assessed. [Table 6](#page-100-2) shows the assessments that will be performed at the Scr... | [
"ZRHR-REXC-04-JP Clinical Study Protocol Confidential Final 2.0/08 July 2013 Page 102 of 171"
] |
NCT01970982 | 9.2 | Confinement Period (Days -2 to 6) | 9.2 Confinement Period (Days -2 to 6) | [] |
NCT01970982 | 9.2.1 | Admission (Day -2) | 9.2.1 Admission (Day -2) The procedures of Day -2 can be performed in order deemed most practical except product test which will be the last assessment prior to enrolment after all eligibility criteria have been met. [Table 7](#page-102-1) shows the assessments that will be performed at Admission (Day -2): Table 7. Tim... | [] |
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