protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03386474 | 9.3.3 | Prior surgical and medical procedures | 9.3.3 Prior surgical and medical procedures Prior surgical and medical procedures (ocular and non-ocular) will be summarized using number and percent of patients by primary system organ class and preferred term according to the MedDRA dictionary. Prior surgical and medical procedures are those that have a start date pr... | [] |
NCT03386474 | 9.3.4 | Concomitant medications | 9.3.4 Concomitant medications Concomitant medications (ocular and non-ocular) will be summarized using number and percent of patients by ATC class and preferred term according to the WHO Drug reference list dictionary. A concomitant medication is defined as any medication taken at least once after the first injection o... | [] |
NCT03386474 | 9.3.5 | Concomitant surgical and medical procedures | 9.3.5 Concomitant surgical and medical procedures Concomitant surgical and medical procedures (ocular and non-ocular) will be summarized using number and percent of patients by primary system organ class and preferred term according to the MedDRA dictionary. Concomitant surgical and medical procedures are those that oc... | [] |
NCT03386474 | 9.4 | Analysis of safety and efficacy variable(s) | 9.4 Analysis of safety and efficacy variable(s) The objective of this study is to collect data on the safety and efficacy of the brolucizumab 6 mg drug product intended for commercialization in patients with nAMD previously treated in the CRTH258A2301 study to support comparability to the drug product used in Phase III... | [] |
NCT03386474 | 9.4.1 | Safety and efficacy variable(s) | 9.4.1 Safety and efficacy variable(s) Safety and efficacy variables: - Treatment emergent Adverse Events - Best-corrected visual acuity - q12 treatment status at Week 20 - ADA status including drug exposure - CSFT - Intraocular pressure - Vital signs | [] |
NCT03386474 | 9.4.2 | Statistical model, hypothesis, and method of analysis | 9.4.2 Statistical model, hypothesis, and method of analysis Formal hypothesis testing is not planned for this study.
Treatment emergent Adverse Events Treatment emergent AEs are defined as AEs which start on or after the time of the first injection of study treatment in this extension study and until the patient exits... | [
"Treatment emergent Adverse Events",
"Best-Corrected Visual Acuity",
"q12 treatment status at Week 20",
"Anti-drug antibodies",
"Central Subfield Thickness",
"Intraocular pressure",
"Vital signs"
] |
NCT03386474 | 9.4.3 | Handling of missing values/censoring/discontinuations | 9.4.3 Handling of missing values/censoring/discontinuations Missing BCVA data will be imputed using LOCF. Observed values from both scheduled and unscheduled visits will be used for the LOCF imputation. For patients with no post baseline value, no imputation will be performed. The details regarding handling of missing/... | [] |
NCT03386474 | 9.4.4 | Sensitivity analyses | 9.4.4 Sensitivity analyses
Best-Corrected Visual Acuity Analyses of the BCVA variables described in [Section 9.4.2](#page-41-0) will be performed using observed data.
Central Subfield Thickness Analyses of the CSFT variables described in [Section 9.4.2](#page-41-0) will be performed using observed data. | [
"Best-Corrected Visual Acuity",
"Central Subfield Thickness"
] |
NCT03386474 | 9.5 | Analysis of secondary variables | 9.5 Analysis of secondary variables Not applicable | [] |
NCT03386474 | 9.5.1 | Efficacy variables | 9.5.1 Efficacy variables Not applicable | [] |
NCT03386474 | 9.5.2 | Safety variables | 9.5.2 Safety variables Not applicable | [] |
NCT03386474 | 9.5.3 | Resource utilization | 9.5.3 Resource utilization Not applicable | [] |
NCT03386474 | 9.5.4 | Pharmacokinetics | 9.5.4 Pharmacokinetics Not applicable | [] |
NCT03386474 | 9.5.5 | DNA | 9.5.5 DNA Not applicable | [] |
NCT03386474 | 9.5.6 | Biomarkers | 9.5.6 Biomarkers Not applicable | [] |
NCT03386474 | 9.5.7 | PK/PD | 9.5.7 PK/PD Not applicable | [] |
NCT03386474 | 9.6 | Analysis of exploratory variables | 9.6 Analysis of exploratory variables Not applicable | [] |
NCT03386474 | 9.7 | Interim analyses | 9.7 Interim analyses An interim analysis might be conducted when 50 patients are treated with brolucizumab 6 mg for 6 months to support a brolucizumab Biologic License Application submission at the earliest possible time point, which is currently planned for end of 2018. The interim analysis will be performed with an u... | [] |
NCT03386474 | 9.8 | Sample size calculation | 9.8 Sample size calculation Approximately 75 to100 patients who completed study CRTH258A2301 are expected to be enrolled in this study. This sample size is not based on a power calculation and depends on the number of patients in the core study fulfilling the eligibility criteria of the extension study (see [Section 4\... | [] |
NCT03386474 | 10 | Ethical considerations | 10 Ethical considerations | [] |
NCT03386474 | 10.1 | Regulatory and ethical compliance | 10.1 Regulatory and ethical compliance This clinical study was designed and shall be implemented, executed and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC, US CFR 21, and Japanese Ministry of ... | [] |
NCT03386474 | 10.2 | Informed consent procedures | 10.2 Informed consent procedures Eligible patients/subjects may only be included in the study after providing (witnessed, where required by law or regulation), IRB/IEC-approved informed consent, or, if applicable after such consent has been provided by a legally acceptable representative(s) of the patient. Informed con... | [] |
NCT03386474 | 10.3 | Responsibilities of the investigator and IRB/IEC | 10.3 Responsibilities of the investigator and IRB/IEC Before initiating a trial, the investigator/institution must obtain approval/favorable opinion from the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for the trial protocol, informed consent form, consent form updates, subject recruitment procedu... | [] |
NCT03386474 | 10.4 | Publication of study protocol and results | 10.4 Publication of study protocol and results The key design elements of this protocol will be posted in a publicly accessible database such as clinicaltrials.gov. In addition, upon study completion and finalization of the study report the results of this trial will be either submitted for publication and/or posted in... | [] |
NCT03386474 | 10.5 | Quality Control and Quality Assurance | 10.5 Quality Control and Quality Assurance Novartis maintains a robust Quality Management (QM) system that includes all activities involved in quality assurance and quality control, including the assignment of roles and responsibilities, the reporting of results, and the documentation of actions and escalation of issue... | [] |
NCT03386474 | 11 | Protocol adherence | 11 Protocol adherence This protocol defines the study objectives, the study procedures and the data to be collected on study participants. Additional assessments required to ensure safety of patients/subjects should be administered as deemed necessary on a case by case basis. Under no circumstances including incidental... | [] |
NCT03386474 | 11.1 | Protocol amendments | 11.1 Protocol amendments Any change or addition to the protocol can only be made in a written protocol amendment that must be approved by Novartis, health authorities where required, and the IRB/IEC prior to implementation. Only amendments that are intended to eliminate an apparent immediate hazard to patients/subjects... | [] |
NCT03386474 | 12 | References | 12 References References are available upon request. Bloch SB, Larsen M, Munch IC (2012) Incidence of legal blindness from age-related macular degeneration in Denmark: Year 2000 to 2010. Am J Ophthalmol; 153:209-13. Campbell JP, Bressler SB, Bressler NM (2012) Impact of availability of anti-vascular endothelial growth ... | [] |
NCT03400943 | 1 | Title page | 1. Title page A randomized, parallel-group, double-blind and open-label, placebo-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids Short title: Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids Acronym: ASTEROID 3 Test drug: BAY 1002... | [
"Confidential",
"Signature of the sponsor's medically responsible person",
"Signature of principal investigator"
] |
NCT03400943 | 2 | Synopsis | 2. Synopsis This section was changed in Amendment 2, see Section [15.1.1](#page-80-1) | Title | A randomized, parallel-group, double-blind and open-label placebocontrolled, multicenter study to assess the efficacy and safety of vilaprisanin subjects with uterine fibroids | |------------------------------|--------------... | [
"Protocol Amendment Summary of Changes Table",
"Amendment 6 (17 FEB 2020)",
"Overall Rationale for the Amendment:",
"Short summary for sites:",
"List of abbreviations",
"Definition of terms"
] |
NCT03400943 | 3 | Introduction | 3. Introduction With the implementation of protocol amendment 5 (version 5.0) no new subjects will be enrolled in the study and no subjects will receive any further study drug treatment. Any subjects who have taken at least one dose of study medication (including the subjects who completed the study or were prematurely... | [
"Results from chronic carcinogenicity studies with vilaprisan in rodents (rat and mice)",
"Benefit risk assessment"
] |
NCT03400943 | 4 | Study objectives | 4. Study objectives The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids. With th... | [] |
NCT03400943 | 5 | Study design | 5. Study design This section was changed in Amendment 2, see Section [15.1.1](#page-80-1) This is a randomized, parallel-group, double-blind and open-label, placebo-controlled, multicenter study. Blinding was applied to Treatment Groups A1, B1, and B2; Treatment Group A2 was open-label. The study is conducted in the US... | [
"The primary efficacy variable is:",
"Justification of the design",
"Placebo control and blinding:",
"Study design valid with the implementation of protocol amendment 5 (version 5.0):",
"Efficacy / pharmacodynamic assessments:",
"Safety monitoring:",
"Endometrial monitoring",
"Liver monitoring",
"Ad... |
NCT03400943 | 6 | Study population | 6. Study population
Eligibility No longer valid, since no new subjects will be enrolled in this study with the implementation of protocol amendment 5 (version 5.0). Originally the study population had to fulfill the following criteria: Women with symptomatic uterine fibroids meeting all inclusion and presenting none o... | [
"Eligibility"
] |
NCT03400943 | 6.1 | Inclusion criteria | 6.1 Inclusion criteria - 1. Signed and dated informed consent - 2. Women, 18 years or older at the time of Visit 1 - 3. Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter ≥30 mm - 4. The largest diameter of any uterine fibroid is 80.00 mL documented by th... | [] |
NCT03400943 | 6.2 | Exclusion criteria | 6.2 Exclusion criteria This section was changed in Amendment 2, see Section [15.1.1](#page-80-1) - 1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) - 2. Hypersensitivity to any ingredient of the study drug - 3. Any condition requiring immediate blood transf... | [] |
NCT03400943 | 6.3 | Justification of selection criteria | 6.3 Justification of selection criteria The exclusion criteria are valid for known or suspected conditions and were chosen to ensure that subjects with specific risks for administration of the study drugs and/or subjects with conditions that may have an effect on the aims of the study are excluded. | [] |
NCT03400943 | 6.4 | Withdrawal of subjects from study | 6.4 Withdrawal of subjects from study | [] |
NCT03400943 | 6.4.1 | Withdrawal | 6.4.1 Withdrawal No longer valid, since with the implementation of protocol amendment 5 (version 5.0) no subjects will start or continue treatment in this study. Originally, the criteria for withdrawal from the study or from the study treatment were the following:
Withdrawal criteria Subjects must be withdrawn from th... | [
"Withdrawal criteria",
"Follow-up of subjects prematurely withdrawing from study treatment or during followup",
"Screening failure",
"Dropout",
"Contacting of treated subjects who already left the study",
"General procedures"
] |
NCT03400943 | 6.4.2 | Replacement | 6.4.2 Replacement Dropouts will not be replaced. Version 6.0 Page: 32 of 113 | [] |
NCT03400943 | 6.5 | Subject identification | 6.5 Subject identification At screening upon signing the informed consent form and registering the subject in the interactive voice/web response system (IVRS/IWRS), each subject was assigned a unique multi-digit SID number by the site for unambiguous identification. The SID number was constructed as follows: - Digits 1... | [] |
NCT03400943 | 7 | Treatments | 7. Treatments Instructions in Sections 7.1 to 7.4 are no longer valid, since with the implementation of protocol amendment 5 (version 5.0) no subjects will start or continue treatment in this study. Originally, the instructions in Sections 7.1 to 7.4 were the following: | [] |
NCT03400943 | 7.1 | Treatments to be administered | 7.1 Treatments to be administered Eligible subjects will be randomized to one of the following treatment groups: A1: vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode A2: vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break B1: placebo, 1 treatment period of 12 weeks, and... | [
"Start of treatment",
"Missed intake of study drug",
"Diet"
] |
NCT03400943 | 7.2 | Identity of study treatment | 7.2 Identity of study treatment The investigational medicinal product vilaprisan and matching placebo are round immediaterelease tablets, 6 mm in diameter and coated with a dark red coat (see [Table 7—1](#page-34-1)). Version 6.0 Page: 34 of 113 Table 7—1: Identity of test drug/vilaprisan tablets and matching placebo |... | [] |
NCT03400943 | 7.3 | Treatment assignment | 7.3 Treatment assignment At Visit 3 (randomization), eligible subjects will be randomized via the IVRS/IWRS to one of the treatment groups (see Section [7.1](#page-32-0)). The site will receive confirmation on the completion of the randomization procedure from the IVRS/IWRS. The confirmation will be considered as sourc... | [] |
NCT03400943 | 7.4 | Dosage and administration | 7.4 Dosage and administration See Section [7.1](#page-32-0) for administration details. | [] |
NCT03400943 | 7.5 | Blinding | 7.5 Blinding Forward looking instructions regarding blinding are no longer valid, since with the implementation of protocol amendment 5 (version 5.0) no subjects will start or continue treatment in this study. However, for the subjects randomized in this study before the temporary pause, the blinding will be maintained... | [] |
NCT03400943 | 7.5.1 | Blinding measures | 7.5.1 Blinding measures Vilaprisan tablets and respective placebo tablets are identical in appearance (size, shape, color). The packaging and labeling will be designed to maintain the blinding of the investigator's team and the subjects for Treatment Groups A1, B1, and B2. Treatment Group A2 is open-label because the s... | [] |
NCT03400943 | 7.5.2 | Unblinding | 7.5.2 Unblinding In compliance with applicable regulations, in the event of a suspected, unexpected serious adverse reaction (SUSAR) (see Section [9.6.1.5](#page-48-0)) related to the blinded treatment, the subject's treatment code will usually be unblinded by the sponsor's Pharmacovigilance department before reporting... | [] |
NCT03400943 | 7.5.3 | Emergency unblinding by the investigator | 7.5.3 Emergency unblinding by the investigator In case of emergency or any finding that requires unblinding, the investigator can break the blind for an individual subject via IVRS/IWRS consistent with the unblinding instructions provided. This will allow breaking the blind for an individual subject without impairing t... | [] |
NCT03400943 | 7.6 | Drug logistics and accountability | 7.6 Drug logistics and accountability No longer valid, since with the implementation of protocol amendment 5 (version 5.0) no subjects will start or continue treatment in this study and therefore no study medication will be newly distributed. All unused study drug should have been returned during the temporary pause an... | [] |
NCT03400943 | 7.7 | Treatment compliance | 7.7 Treatment compliance To monitor compliance, the subjects were required to complete an electronic Diary (eDiary) daily throughout the study. The date of each study drug intake was tracked via the eDiary. The eDiary was dispensed at Visit 1 and the completeness of the eDiary data reviewed by the investigator or desig... | [] |
NCT03400943 | 8 | Non-study therapy | 8. Non-study therapy | [] |
NCT03400943 | 8.1 | Prior and concomitant therapy | 8.1 Prior and concomitant therapy All concomitant medications administered after signing of informed consent until the completion of study participation[8](#page-36-4), including topical (eg, vaginal) preparations and over the counter drugs are to be recorded in the eCRF (trade name, dose, unit, frequency, route, start... | [] |
NCT03400943 | 8.1.1 | Iron supplementation | 8.1.1 Iron supplementation In subjects with hemoglobin 10.9 g/dL in blood, iron supplementation should be offered in a standardized regimen (see Section [9.7.1](#page-65-7)) consistent with local standards of practice and at the investigator's discretion. Iron supplementation will not be considered a study medication a... | [] |
NCT03400943 | 8.1.2 | Progestin therapy for induction of bleeding | 8.1.2 Progestin therapy for induction of bleeding If required, subjects were given an appropriate progestin therapy for induction of bleeding. Progestin therapy will not be considered as study medication and will be documented as concomitant medication. | [] |
NCT03400943 | 8.2 | Post-study therapy | 8.2 Post-study therapy Before the temporary pause, it was foreseen that subjects completing the treatment periods will participate in the post treatment FUP without drug treatment. According to the rules of the temporary pause, subjects were required to not start any new treatment period and thereby those subjects ente... | [] |
NCT03400943 | 9 | Procedures and variables | 9. Procedures and variables | [] |
NCT03400943 | 9.1 | Tabular schedule of evaluations | 9.1 Tabular schedule of evaluations No longer valid, since with the implementation of protocol amendment 5 (version 5.0) no subjects will be recruited and none of the enrolled subjects will receive further study drug treatment. All subjects who were randomized and started treatment before the temporary pause will be as... | [] |
NCT03400943 | 9.2 | Visit description | 9.2 Visit description No longer valid, since with the implementation of protocol amendment 5 (version 5.0) all subjects will need to come to the site for the safety closeout visit. In most cases the procedures scheduled for this visit will not take place on the same day. The second scheduled visit, the "Safety result r... | [] |
NCT03400943 | 9.2.1 | Unscheduled visits | 9.2.1 Unscheduled visits If deemed necessary for an individual subject, the investigator or designee, at his/her discretion, may arrange visits in addition to the scheduled study visits. A possible reason for unscheduled visits would be the requirement for follow up investigations. | [] |
NCT03400943 | 9.2.2 | Optional pre-screening phone contact | 9.2.2 Optional pre-screening phone contact No longer valid, since with the implementation of protocol amendment 5 (version 5.0) no new subjects will be recruited. | [] |
NCT03400943 | 9.2.3 | Scheduled visits | 9.2.3 Scheduled visits With the implementation of protocol amendment 5 (version 5.0) all subjects who took at least one dose of study medication will need to come to the site for the safety closeout visit. For details regarding this safety closeout visit please see Section [9.1](#page-37-0). The second scheduled visit,... | [] |
NCT03400943 | 9.3 | Population characteristics | 9.3 Population characteristics With implementation of protocol amendment 5 (version 5.0) no new subjects will be recruited. This section describes the data collection performed in subjects enrolled before the temporary pause. | [] |
NCT03400943 | 9.3.1 | Demographic | 9.3.1 Demographic Demographic data (eg, year of birth, age at Visit 1, race, ethnic group, educational level) and other population characteristics including smoking habits and alcohol consumption were collected consistent with the original schedule of procedures in protocol amendment 3 (version 3.0). | [] |
NCT03400943 | 9.3.2 | Medical history | 9.3.2 Medical history Medical history findings (ie, previous diagnoses, diseases or surgeries) meeting all criteria listed below were collected as available to the investigator: - Not pertaining to the study indication - Start before signing of the informed consent - Considered relevant for the subject's study eligibil... | [] |
NCT03400943 | 9.3.3 | Reproductive, menstrual, and fibroids history | 9.3.3 Reproductive, menstrual, and fibroids history Reproductive and menstrual history includes information on menarche, births, other pregnancies, and inability to conceive. Fibroids history includes information on family history, onset of symptoms, diagnosis, and previous medical treatments and procedures, if applica... | [] |
NCT03400943 | 9.3.4 | Heavy menstrual bleeding questions | 9.3.4 Heavy menstrual bleeding questions This set of questions has been developed as a tool to identify women with HMB. It could have been used at Visit 1 and the responses could have been entered directly into electronic data capturing system RAVE, which is considered as primary source data. The questionnaire could al... | [] |
NCT03400943 | 9.4 | Efficacy | 9.4 Efficacy This section details the procedures for collecting efficacy variables. A concise listing of efficacy variables as collected before the temporary pause is given in Section [10.3.1](#page-66-1). The complete list of variables to be analyzed for this study will be provided in the Statistical Analysis Plan (SA... | [] |
NCT03400943 | 9.4.1 | Alkaline hematin method to assess HMB | 9.4.1 Alkaline hematin method to assess HMB This section was changed in Amendment 2, see Section [15.1.1](#page-80-1) During the duration of the study, subjects were required to use selected types of sanitary products provided (pads and/or tampons). During the entire duration of the study, subjects were to collect thei... | [] |
NCT03400943 | 9.4.2 | Ultrasound (efficacy) to assess uterine fibroids | 9.4.2 Ultrasound (efficacy) to assess uterine fibroids This section was changed in Amendment 2, see Section [15.1.1](#page-80-1) If possible, the same examiner should have conducted all ultrasound examinations of a subject throughout the study and the same ultrasound machine (per site) should have been used throughout ... | [] |
NCT03400943 | 9.5 | Pharmacokinetics / pharmacodynamics | 9.5 Pharmacokinetics / pharmacodynamics With the implementation of protocol amendment 5 (version 5.0) no new subjects will be recruited and no study medication will be given to the subjects who have been enrolled in the study. This section describes processes performed in subjects enrolled before the temporary pause. | [] |
NCT03400943 | 9.5.1 | Drug measurements | 9.5.1 Drug measurements Blood samples for measurement of vilaprisan in plasma for PK were to be collected at the time points given in the original schedule of procedures. At Visit 5, the PK sample was to be taken predose. At Visit 6, 3 PK samples were to be taken. The first sample was to be taken before intake of study... | [] |
NCT03400943 | 9.5.2 | Population pharmacokinetic analysis of vilaprisan | 9.5.2 Population pharmacokinetic analysis of vilaprisan Based on the plasma concentrations, the variability in vilaprisan PK will be analyzed using population PK modeling. This analysis might start prior to database lock (eg, at the moment that approximately 80% of the expected PK samples have been measured). Appropria... | [] |
NCT03400943 | 9.5.3 | Pharmacokinetic/pharmacodynamic relationship of vilaprisan | 9.5.3 Pharmacokinetic/pharmacodynamic relationship of vilaprisan Optionally, a population PK/PD model could be used to describe the effect of vilaprisan exposure on PD data related to efficacy and safety such as bleeding intensity and endocrine hormone levels. The final population PK model that will be applied to descr... | [] |
NCT03400943 | 9.6.1 | Adverse events | 9.6.1 Adverse events | [] |
NCT03400943 | 9.6.1.1 | Definitions | 9.6.1.1 Definitions
Definition of AE This section was changed in Amendment 2, see Section [15.1.1](#page-80-1) In a clinical study, an AE is any untoward medical occurrence (ie, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subj... | [
"Definition of AE",
"Definition of SAE",
"The following types of events are excluded from SAE reporting:"
] |
NCT03400943 | 9.6.1.2 | Classifications for AE assessment | 9.6.1.2 Classifications for AE assessment All AEs will be assessed and documented by the investigator according to the categories detailed below. | [] |
NCT03400943 | 9.6.1.2.1 | Seriousness | 9.6.1.2.1 Seriousness For each AE, the seriousness must be determined according to the criteria given in Section [9.6.1.1](#page-43-0). | [] |
NCT03400943 | 9.6.1.2.2 | Intensity | 9.6.1.2.2 Intensity The intensity of an AE is classified according to the following categories: - Mild - Moderate - Severe | [] |
NCT03400943 | 9.6.1.2.3 | Causal relationship | 9.6.1.2.3 Causal relationship The assessment of the causal relationship between an AE and the administration of treatment is a decision to be made by the investigator, who is a qualified physician, based on all information available at the time of the completion of the eCRF. The assessment is based on the question whet... | [
"Causal relationship to protocol-required procedure(s)"
] |
NCT03400943 | 9.6.1.2.4 | Action taken with study treatment | 9.6.1.2.4 Action taken with study treatment Any action on study treatment to resolve the AE is to be documented using the categories listed below. Version 6.0 Page: 47 of 113 The study treatment action should be recorded as detailed in the eCRF. - Drug withdrawn - Drug interrupted - Dose not changed - Not applicable - ... | [] |
NCT03400943 | 9.6.1.2.5 | Other specific treatment(s) of AEs | 9.6.1.2.5 Other specific treatment(s) of AEs - None - Remedial drug therapy - Other | [] |
NCT03400943 | 9.6.1.2.6 | Outcome | 9.6.1.2.6 Outcome The outcome of the AE is to be documented as follows: - Recovered/resolved - Recovering/resolving - Recovered/resolved with sequelae - Not recovered/not resolved - Fatal - Unknown | [] |
NCT03400943 | 9.6.1.3 | Assessments and documentation of AEs | 9.6.1.3 Assessments and documentation of AEs Attention is to be paid to the occurrence of AEs at all stages of the examination. Thus, the subject should be closely observed by the investigator. AEs observed, mentioned on open questioning by a member of the investigator team or spontaneously reported by the subject will... | [] |
NCT03400943 | 9.6.1.4 | Reporting of SAEs | 9.6.1.4 Reporting of SAEs The definition of SAEs is given in Section [9.6.1.1.](#page-43-0) Each SAE must be followed up until resolution or stabilization by submission of updated reports to the designated recipient.
Investigator's notification of the sponsor All investigators will be thoroughly instructed and trained... | [
"Investigator's notification of the sponsor",
"Notification of the Independent Ethics Committees/Institutional Review Boards",
"Notification of the authorities",
"Sponsor's notification of the investigational site"
] |
NCT03400943 | 9.6.1.5 | Expected AEs | 9.6.1.5 Expected AEs For this study, the applicable reference document is the most current version of the IB. Overview listings of frequent events that have occurred so far in the clinical development are shown in the current IB. If relevant new safety information is identified, the information will be integrated into ... | [] |
NCT03400943 | 9.6.1.6 | Adverse events of special safety interest | 9.6.1.6 Adverse events of special safety interest The investigators will assess all AEs to determine if they are AEs of special interest (AESIs) and document this in the eCRF. Adverse events from the following areas should be considered for reporting as AESI according to the following guidance: - HMB (especially after ... | [] |
NCT03400943 | 9.6.2 | Pregnancies | 9.6.2 Pregnancies An acceptable nonhormonal contraceptive method has to be used starting at Screening Visit 1 and continued until the end of the study. Barrier contraception (eg, condoms with spermicide) will be dispensed as required by the subject. This is not required if contraception is achieved by a permanent metho... | [
"Pregnancies occurring during the study"
] |
NCT03400943 | 9.6.3 | Further safety | 9.6.3 Further safety | [] |
NCT03400943 | 9.6.3.1 | Laboratory evaluations | 9.6.3.1 Laboratory evaluations This section was changed in Amendment 2, see Section [15.1.1](#page-80-1) Only blood samples analyzed at the central laboratory will be considered for analysis. The name and address for the central lab service provider can be found in the documentation supplied by the vendor. The followin... | [
"Hemoglobin (Hb concentration)",
"Parameters measured for adrenal monitoring:"
] |
NCT03400943 | 9.6.3.2 | Endometrial biopsies | 9.6.3.2 Endometrial biopsies | [] |
NCT03400943 | 9.6.3.2.1 | Algorithm for endometrial biopsy evaluations | 9.6.3.2.1 Algorithm for endometrial biopsy evaluations Figure 9–1: Overview of the endometrial safety monitoring algorithm  1 Normal is defined as: Diagnosis of safety read of all 3 individual components of the multiread needs to be "benign endometrium" in Part II of the evaluation form. In addi... | [] |
NCT03400943 | 9.6.3.2.2 | Timing of last endometrial biopsies | 9.6.3.2.2 Timing of last endometrial biopsies Each subject should have an endometrial biopsy with a normal[10](#page-54-0) result documented from a timepoint taken at the earliest 7 days before last study drug intake. For subjects with menstrual cycles the endometrial biopsy should be taken between Day 7 to 15 (inclusi... | [] |
NCT03400943 | 9.6.3.2.3 | Sampling of endometrial biopsies | 9.6.3.2.3 Sampling of endometrial biopsies All endometrial biopsies must be collected by a gynecologically well experienced physician. A negative pregnancy test is a prerequisite for performing an endometrial biopsy. In addition, an ultrasound should be performed before each biopsy. If a cervical smear sample is collec... | [] |
NCT03400943 | 9.6.3.2.4 | Assessment of endometrial biopsies | 9.6.3.2.4 Assessment of endometrial biopsies Blinding and distribution of biopsy samples will be organized by the central laboratory. Central assessment of endometrial biopsies will be performed in 2 steps, i.e. safety assessment 10 Normal is defined as: Diagnosis of safety read of all 3 individual components of the mu... | [
"Safety assessment",
"Multi-reader assessment"
] |
NCT03400943 | 9.6.3.2.5 | Follow-up of endometrial biopsies with abnormalities | 9.6.3.2.5 Follow-up of endometrial biopsies with abnormalities Endometrial biopsies with a safety-reader diagnosis (Part II of the evaluation form) other than "benign endometrium" (i.e. "Malignant neoplasm", "Endometrial Hyperplasia" with or without atypia) should undergo an expedited multi-reader assessment. If an exp... | [] |
NCT03400943 | 9.6.3.2.6 | Follow-up of PAEC | 9.6.3.2.6 Follow-up of PAEC Besides standard diagnostic criteria (i.e., proliferative/secretory/atrophic endometrium, endometrial hyperplasia) presence of PAEC will be analyzed in all endometrial biopsy samples as part of the multi-reader assessment. The diagnosis of PAEC is based on a constellation of histologic featu... | [] |
NCT03400943 | 9.6.3.2.7 | Heavy menstrual bleeding / suspicious bleeding pattern | 9.6.3.2.7 Heavy menstrual bleeding / suspicious bleeding pattern The study drug was administered in a study population with symptomatic heavy menstrual bleeding. The study drug itself leads to changes in bleeding pattern, mostly amenorrhea during treatment, but can also be associated with intermittent spotting or mild ... | [
"Standard criteria for subjects with unusual HMB or bleeding pattern identified from review of bleeding data or reports by the subject during the temporary pause",
"Evaluation plan for subjects with unusual HMB or new onset bleeding pattern"
] |
NCT03400943 | 9.6.3.2.8 | Unscheduled endometrial biopsy | 9.6.3.2.8 Unscheduled endometrial biopsy Unscheduled endometrial biopsies can result from the requirement to follow-up on abnormal results of a previous biopsy, see Section [9.6.3.2.5](#page-56-0). In addition, also the following two findings trigger unscheduled biopsies: - In case of increased endometrial thickness (1... | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.