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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NCT04985682 | 8.4.2.1 | Effectiveness of ADVATE as On-demand and Prophylactic Treatment | 8.4.2.1 Effectiveness of ADVATE as On-demand and Prophylactic Treatment In all cases, the treatment with ADVATE will be at the discretion of the investigator and will consist of either a prophylactic or on-demand treatment as per the ADVATE Product Label for India. The following information will be recorded by the subj... | [] |
NCT04985682 | 8.4.2.1.1 | Assessment of Effectiveness | 8.4.2.1.1 Assessment of Effectiveness Total number (%) of treated bleeds and their corresponding hemostatic effectiveness ratings using an "excellent-to-none" 4-point Likert scale by the subjects/care-giver (subjects reliefofpainandcessationofobjectivesignsofbleeding(e.g.,swelling, tenderness,anddecreasedrangeofmotioni... | [] |
NCT04985682 | 8.4.2.2 | Determination of Incremental Recovery | 8.4.2.2 Determination of Incremental Recovery The assessment of FVIII levels to determine IR will be mandatory at the Baseline Visit and at the End of Treatment Visit / Study Termination Visit (see Table 2). For a more detailed description of the IR assessment, see Appendix 2.5. | [] |
NCT04985682 | 8.4.2.3 | Blood Sampling for Determination of Factor VIII Level | 8.4.2.3 Blood Sampling for Determination of Factor VIII Level See Appendix 2.4. iv If checked, the investigator should determine whether it is considered as "lack of effect" and, if yes, it should be considered as an AE. | [] |
NCT04985682 | 8.4.3 | Safety | 8.4.3 Safety | [] |
NCT04985682 | 8.4.3.1 | Physical Examination | 8.4.3.1 Physical Examination At screening and all subsequent study visits (as shown in Section 1.3, Table 1), a physical examination will be performed on the following body systems: general appearance, head and neck, eyes and ears, nose and throat, chest, lungs, heart, abdomen, extremities and joints, lymph nodes, skin... | [] |
NCT04985682 | 8.4.3.2 | Adverse Events | 8.4.3.2 Adverse Events At each study visit, subjects will be questioned in a general way to ascertain if AEs have occurred since the previous visit (eg, "Have you had any health problems since your last visit?"). Adverse events are collected from the time informed consent is signed.v Refer to Appendix 3 for AE definiti... | [] |
NCT04985682 | 8.4.3.3 | Vital Signs | 8.4.3.3 Vital Signs Vital signs will include body temperature (°C), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (mmHg). Blood pressure will be measured when subjects are in the supine position. Vitals signs will be measured at all study visits (see Table 1) and will... | [] |
NCT04985682 | 8.4.3.4 | Clinical Laboratory Tests | 8.4.3.4 Clinical Laboratory Tests All clinical laboratory tests will be performed according to the laboratory's standard procedures. Reference ranges will be supplied by the laboratory and used to assess the results for clinical significance and out-of-range changes which may be associated with, or constitute, an AE. v... | [] |
NCT04985682 | 8.4.3.5 | Clinical Pharmacology | 8.4.3.5 Clinical Pharmacology Incremental recovery will be determined at baseline and at study completion (see Table 2 and Appendix 2.5). | [] |
NCT04985682 | 8.4.4 | Volume of Blood to Be Drawn from Each Subject | 8.4.4 Volume of Blood to Be Drawn from Each Subject The volume of blood to be drawn from each subject for laboratory assessments will be specified in the laboratory manual. | [] |
NCT04985682 | 8.4.5 | Backup Samples and Biobanking | 8.4.5 Backup Samples and Biobanking Backup samples taken and stored short-term may be used for example for re-testing, follow-up of an AE(s) or other test results, and/or assay development. After study testing is completed, the remaining samples may be stored in a coded form for no more than 2 years after the final stu... | [] |
NCT04985682 | 9 | STATISTICAL CONSIDERATIONS | 9. STATISTICAL CONSIDERATIONS | [] |
NCT04985682 | 9.1 | Statistical Analysis Process | 9.1 Statistical Analysis Process The study will be analyzed by the sponsor or its agent. The SAP will provide the statistical methods and definitions for the analysis of the efficacy and safety data, as well as describe the approaches to be taken for summarizing other study information such as subject disposition, demo... | [] |
NCT04985682 | 9.2 | Planned Interim Analysis, Adaptive Design, and Data Monitoring Committee | 9.2 Planned Interim Analysis, Adaptive Design, and Data Monitoring Committee No interim analysis, adaptive design, or data monitoring committee (DMC) is planned for this study. | [] |
NCT04985682 | 9.3 | Sample Size and Power Considerations | 9.3 Sample Size and Power Considerations According to the WFH Report on the Annual Global Survey 2017 (World Federation of Hemophilia, 2018) there were a total of 15,920 cases of hemophilia A in India in 2017. Due to the low prevalence of hemophilia A and the difficulty in switching patients from their current therapy,... | [] |
NCT04985682 | 9.4 | Statistical Analysis Set(s) | 9.4 Statistical Analysis Set(s) | [] |
NCT04985682 | 9.4.1 | Effectiveness Full Analysis Set (EFAS) | 9.4.1 Effectiveness Full Analysis Set (EFAS) The EFAS will be comprised of all subjects for whom all inclusion and none of the exclusion criteria are met. This dataset will be used for the efficacy analyses. | [] |
NCT04985682 | 9.4.2 | Safety Analysis Set (SAS) | 9.4.2 Safety Analysis Set (SAS) All subjects having received ADVATE at any time during the study will be included in the SAS. | [] |
NCT04985682 | 9.5 | Efficacy Analyses | 9.5 Efficacy Analyses | [] |
NCT04985682 | 9.5.1 | Primary Efficacy Endpoint | 9.5.1 Primary Efficacy Endpoint Not applicable. There is no primary efficacy endpoint. | [] |
NCT04985682 | 9.5.2 | Secondary Efficacy Endpoints | 9.5.2 Secondary Efficacy Endpoints The annualized bleeding rate (ABR) during the prophylactic treatment will be assumed to have a negative binomial distribution, and the mean ABR (95% CI) will be estimated using a generalized linear model (GLM). The total ABR and ABR by bleed cause/ site, i.e. joint, non-joint, target ... | [] |
NCT04985682 | 9.5.3 | Multiplicity Adjustment | 9.5.3 Multiplicity Adjustment As the analyses will be descriptive in nature, no adjustments for multiplicity will be applied. | [] |
NCT04985682 | 9.6 | Safety Analyses | 9.6 Safety Analyses Frequency counts and percentages for possibly or probably related SAEs (including FVIII inhibitor formation) as well as for subjects with possibly or probably related SAEs (including FVIII inhibitor formation) that occurred during or after first ADVATE infusion will be summarized. The incidence of F... | [] |
NCT04985682 | 9.7 | Other Analyses | 9.7 Other Analyses No other analyses are planned at this time. For non-commercial use only TAK-761-4009 Protocolversion 1.0 ADVATE 01 DEC 2022 | [] |
NCT04985682 | 10 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
Appendix 1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
Appendix 1.1 Regulatory and Ethical Considerations This study is conducted in accordance with current applicable regulations including ICH E6, EU Directive 2001/20/EC, and all updates, as wel... | [
"Appendix 1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS",
"Appendix 1.1 Regulatory and Ethical Considerations",
"Appendix 1.2 Sponsor's Responsibilities",
"Good Clinical Practice Compliance",
"Indemnity/Liability and Insurance",
"Public Posting of Study Information",
"Submission of Summary o... |
NCT04985682 | 11 | REFERENCES | 11. REFERENCES Bolton-Maggs, P. H. & Pasi, K. J. 2003. Haemophilias A and B. Lancet, 361, 1801-1809. - Lee, C. A. 2007. Prevention of haemophilic synovitis: prophylaxis. Haemophilia, 13 Suppl 3, 20- 25. - Shapiro, A. D., Donfield, S. M., Lynn, H. S., Cool, V. A., Stehbens, J. A., Hunsberger, S. L., Tonetta, S. & Gomper... | [] |
NCT05059600 | 2 | SYNOPSIS | 2. SYNOPSIS
Name of Sponsor/Company: Sage Therapeutics, Inc. (hereafter referred to as Sage Therapeutics, or Sage)
Name of Investigational Product: ZULRESSO®
Name of Active Ingredient: brexanolone (previously referred to as SAGE-547)
Title of Study: Assessment of Safe-Use Conditions for Administration of ZULRESSO i... | [
"Name of Sponsor/Company:",
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"Planned Duration for each Study Participant:",
"Objectives and Endpoints:",
"Primary",
"Secondary",
"Endpoints",
"Primary",
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"Study Description:",
"Number of Particip... |
NCT05059600 | 4 | LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS | 4. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS The following abbreviations and specialist terms are used in this study protocol. Table 4: Abbreviations and Specialist Terms | Abbreviation | Definition | |--------------|--------------------------------------------------------------------------------------------------... | [] |
NCT05059600 | 5 | INTRODUCTION | 5. INTRODUCTION Postpartum depression (PPD) is a serious mood disorder estimated to affect approximately 10% to 20% of women giving birth globally. In the United States, estimates of new mothers identified with PPD each year vary by state from 10% to 24% with an overall average of 13.2% (Bauman 2020). PPD is defined in... | [] |
NCT05059600 | 5.1 | Brexanolone (ZULRESSO® ) | 5.1. Brexanolone (ZULRESSO® ) Brexanolone injection is approved by the US FDA under the trade name ZULRESSO for the treatment of PPD in adults. The brexanolone drug product is a proprietary formulation of brexanolone drug substance (chemically identical to endogenous allopregnanolone) and excipients. In clinical studie... | [] |
NCT05059600 | 5.2 | Study Rationale | 5.2. Study Rationale In the US, ZULRESSO is available commercially only through a restricted program called the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS) due to the risk of serious harm resulting from excessive sedation or sudden loss of consciousness during the infusion. The requirement for ZULRESSO to b... | [] |
NCT05059600 | 5.3 | Dose Justification | 5.3. Dose Justification The dose for this study is consistent with the recommended dose in the FDA-approved US Prescribing Information, which is a continuous 60-hour IV infusion, administered as follows: - 0 to 4 hours: Initiate with a dosage of 30 mcg/kg/h - 4 to 24 hours: Increase dosage to 60 mcg/kg/h - 24 to 52 hou... | [] |
NCT05059600 | 6 | STUDY OBJECTIVES AND ENDPOINTS | 6. STUDY OBJECTIVES AND ENDPOINTS | [] |
NCT05059600 | 6.1 | Primary Objective | 6.1. Primary Objective The primary objective of the study is to evaluate whether the safe-use conditions for administration of ZULRESSO can be implemented in a home setting. | [] |
NCT05059600 | 6.2 | Secondary Objective | 6.2. Secondary Objective The secondary objective of the study is: • To identify any process and procedural changes to be implemented for ZULRESSO administration at home  | [] |
NCT05059600 | 6.4 | Endpoints | 6.4. Endpoints | [] |
NCT05059600 | 6.4.1 | Primary Endpoint | 6.4.1. Primary Endpoint • Incidence of treatment-emergent adverse events (TEAEs) leading to dose interruption/discontinuation. | [] |
NCT05059600 | 6.4.2 | Secondary Endpoints | 6.4.2. Secondary Endpoints - Incidence of nonadherence with the safe-use conditions for administration of ZULRESSO - Incidence of use-related issues related to the home administration of ZULRESSO - Incidence of all TEAEs - Incidence of medication error  | [] |
NCT05059600 | 7 | INVESTIGATIONAL PLAN | 7. INVESTIGATIONAL PLAN | [] |
NCT05059600 | 7.1 | Overall Study Design | 7.1. Overall Study Design This is an open-label, multicenter study designed to assess the safe-use conditions for administration of ZULRESSO in a home setting to women with PPD with the overall goal to improve patient access to ZULRESSO treatment. The safety monitoring plan for this study incorporates safe-use conditio... | [] |
NCT05059600 | 7.2 | Number of Participants | 7.2. Number of Participants Up to 50 participants may participate. | [] |
NCT05059600 | 7.3 | Treatment Assignment | 7.3. Treatment Assignment In this open-label study, participants will be administered a single, continuous, 60-hour, IV infusion of ZULRESSO starting on Day 1. | [] |
NCT05059600 | 7.4 | Dose Adjustment Criteria | 7.4. Dose Adjustment Criteria If excessive sedation occurs at any time during the infusion, the infusion will be stopped until the symptoms resolve. The infusion may be resumed at the same or lower dose as clinically appropriate. The infusion will be immediately stopped if pulse oximetry reveals hypoxia. After an episo... | [] |
NCT05059600 | 7.5 | Criteria for Study Termination | 7.5. Criteria for Study Termination Sage Therapeutics may terminate this study or any portion of the study at any time for safety reasons, including the occurrence of AEs or other findings suggesting unacceptable risk to participants, or for administrative reasons. In the event of study termination, Sage Therapeutics w... | [] |
NCT05059600 | 8 | SELECTION AND WITHDRAWAL OF PARTICIPANTS | 8. SELECTION AND WITHDRAWAL OF PARTICIPANTS | [] |
NCT05059600 | 8.1 | Participant Inclusion Criteria | 8.1. Participant Inclusion Criteria Participants must meet all of the following criteria to qualify for participation in this study: - 1. Ambulatory female ≥18 years of age - 2. Participant has a current diagnosis of PPD, as confirmed by the investigator - 3. Participant agrees not to be the primary caregiver of any de... | [] |
NCT05059600 | 8.2 | Participant Exclusion Criteria | 8.2. Participant Exclusion Criteria Participants who meet any of the following criteria are disqualified from participation in this study: - 1. Participant has end stage renal failure - 2. Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection - 3. Participant i... | [] |
NCT05059600 | 8.3 | Screen Failures | 8.3. Screen Failures Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently entered in the study. A minimal set of screen failure information will be collected, including demography, screen failure details, eligibility criteria, and any serious adverse even... | [] |
NCT05059600 | 8.4 | Investigational Product Discontinuation and Early Termination from the Study | 8.4. Investigational Product Discontinuation and Early Termination from the Study A participant may withdraw from the study at any time at his/her own request for any reason. The investigator may discontinue a participant from the study and/or from IP for safety, behavioral, compliance, or administrative reasons. The r... | [] |
NCT05059600 | 8.4.1 | Investigational Product Discontinuation | 8.4.1. Investigational Product Discontinuation If it is necessary to discontinue the IP earlier than planned and consent is not withdrawn, participants will remain in the study and be followed per protocol to capture assessments for the duration of the study period. The reason for IP discontinuation must be documented ... | [] |
NCT05059600 | 8.4.2 | Early Termination from the Study | 8.4.2. Early Termination from the Study At the time of study withdrawal/stopping study participation, if possible, the assessments listed for the post-infusion visit should be conducted. The participant will be permanently discontinued both from the IP and from the study at that time. If the participant withdraws conse... | [] |
NCT05059600 | 8.4.3 | Loss to Follow up | 8.4.3. Loss to Follow up Not applicable | [] |
NCT05059600 | 9 | TREATMENT OF PARTICIPANTS | 9. TREATMENT OF PARTICIPANTS | [] |
NCT05059600 | 9.1 | Description of Investigational Product | 9.1. Description of Investigational Product Brexanolone (ZULRESSO) is a sterile, clear, colorless solution that must be diluted prior to administration as an IV infusion. ZULRESSO will be administered as a single, continuous, IV infusion for 60 hours. Additional details on IP administration are in Section 10.5 and addi... | [] |
NCT05059600 | 9.2 | Prior Medications, Concomitant Medications, Restrictions, and Contraception Requirements | 9.2. Prior Medications, Concomitant Medications, Restrictions, and Contraception Requirements | [] |
NCT05059600 | 9.2.1 | Prior and Concomitant Medications and/or Supplements | 9.2.1. Prior and Concomitant Medications and/or Supplements Participants may receive standard of care for patients diagnosed with PPD, including psychosocial interventions. Any concomitant medication determined medically necessary for the welfare of the participant may be given at the discretion of the investigator at ... | [] |
NCT05059600 | 9.2.2 | Prohibited Medications | 9.2.2. Prohibited Medications Concomitant use of opioids, central nervous system depressants, such as benzodiazepines, or other drugs interacting with the GABAA receptor are prohibited in this study as these drugs may increase the risk for sedation-like AEs if administered concomitantly with ZULRESSO. | [] |
NCT05059600 | 9.2.3 | Other Restrictions | 9.2.3. Other Restrictions The participant should not engage in potentially hazardous activities requiring mental alertness and should not drive a car until after completion of the ZULRESSO infusion and until any feelings of sedation have dissipated. The participant must not leave her house for the duration of the infus... | [] |
NCT05059600 | 9.3 | Intervention after the End of the Study | 9.3. Intervention after the End of the Study Not applicable | [] |
NCT05059600 | 9.4 | Treatment Adherence | 9.4. Treatment Adherence IP will be administered to participants by home healthcare provider staff, as described in Section 10.5. The designated staff will record the time and dose of IP administration in the source documents. Any reasons for nonadherence will also be documented. Deviation(s) from the prescribed dosage... | [] |
NCT05059600 | 9.5 | Randomization and Blinding | 9.5. Randomization and Blinding This is an open-label study in which all participants will receive ZULRESSO. | [] |
NCT05059600 | 10 | INVESTIGATIONAL PRODUCT MATERIALS AND MANAGEMENT | 10. INVESTIGATIONAL PRODUCT MATERIALS AND MANAGEMENT | [] |
NCT05059600 | 10.1 | Investigational Product | 10.1. Investigational Product Brexanolone (ZULRESSO) is a sterile, clear, colorless, and preservative-free solution. It is hypertonic and must be diluted prior to administration as an IV infusion. Each mL of solution contains 5 mg of brexanolone, 250 mg of betadex sulfobutyl ether sodium as a solubilizer, citric acid a... | [] |
NCT05059600 | 10.2 | Investigational Product Packaging and Labeling | 10.2. Investigational Product Packaging and Labeling IP will be provided to the home infusion provider. The IP is sterile-filtered and aseptically filled into 20-mL clear glass vials with a stopper container closure system. IP is intended to be used as a single-use vial. IP labels with all required information and conf... | [] |
NCT05059600 | 10.3 | Investigational Product Storage | 10.3. Investigational Product Storage IP vials should be stored under refrigerated conditions (2 to 8°C) and suitably protected from light. The vials must be carefully stored safely and separately from other drugs. The IP may not be used for any purpose other than the present study. Once the admixture in IV bags is dis... | [] |
NCT05059600 | 10.4 | Investigational Product Preparation | 10.4. Investigational Product Preparation The home infusion provider pharmacist or qualified designee will be responsible for preparing IP for dosing. Refer to the pharmacy manual for specific instructions regarding requirements for IV bags and labeling, infusion sets, infusion preparation and administration instructio... | [] |
NCT05059600 | 10.5 | Investigational Product Administration | 10.5. Investigational Product Administration IP will be administered as a single, continuous, IV infusion for 60 hours, by a home healthcare provider in the participant's home. The prepared admixture will be administered at room temperature. The specific infusion dose of IP will be calculated based on weight (obtained ... | [] |
NCT05059600 | 10.6 | Investigational Product Accountability, Handling, and Disposal | 10.6. Investigational Product Accountability, Handling, and Disposal Upon receipt of IP (vials), the responsible pharmacist or qualified designee, will inspect the IP and complete and follow the instructions regarding receipt and storage in the Investigator's Brochure and (where applicable) in the pharmacy manual. A co... | [] |
NCT05059600 | 10.7 | Product Complaints | 10.7. Product Complaints A product complaint is any written, electronic, or verbal expression of dissatisfaction regarding the identity, quality, reliability, safety, purity, potency, effectiveness, or performance (applicable for approved marketed products) of a drug product after it is released for distribution. In th... | [] |
NCT05059600 | 10.8 | Ancillary Supplies | 10.8. Ancillary Supplies The home infusion provider will provide PVC, non-DEHP, nonlatex infusion sets and a programmable peristaltic infusion pump with alarm for each participant. The pharmacist or qualified designee will ship the infusion sets and preprogrammed infusion pump to the participant's home prior to Day 1. ... | [] |
NCT05059600 | 11 | EFFICACY AND CLINICAL PHARMACOLOGY ASSESSMENTS | 11. EFFICACY AND CLINICAL PHARMACOLOGY ASSESSMENTS | [] |
NCT05059600 | 11.1 | Efficacy Assessments | 11.1. Efficacy Assessments Not applicable | [] |
NCT05059600 | 11.2 | Clinical Pharmacology Assessments | 11.2. Clinical Pharmacology Assessments Not applicable | [] |
NCT05059600 | 12 | SAFETY ASSESSMENTS | 12. SAFETY ASSESSMENTS | [] |
NCT05059600 | 12.1 | Safety Parameters | 12.1. Safety Parameters All assessments will be recorded at the time points summarized in the Schedule of Assessments (Table 3). | [] |
NCT05059600 | 12.1.1 | Demography and Medical History | 12.1.1. Demography and Medical History Demographic characteristics (age, race, sex, ethnicity) and a full medical and surgical history will be documented. Information regarding diagnosis, isolation, and/or hospitalization due to COVID-19 will be documented as part of medical history, AE collection, and prior/concomitan... | [] |
NCT05059600 | 12.1.2 | Weight and Height | 12.1.2. Weight and Height After the participant provides informed consent, a body weight scale will be delivered to the participant's home. The participant will weigh herself on the scale approximately 7 days prior to Day 1 and report her body weight to study personnel. Body weight at screening/baseline is used to calc... | [] |
NCT05059600 | 12.1.3 | Vital Signs | 12.1.3. Vital Signs Vital signs include blood pressure, respiratory rate, heart rate, and oxygen saturation. Blood pressure should be collected in the supine position at all scheduled time points. Respiratory rate, heart rate, and oxygen saturation will be monitored continuously through a wearable device. The wearable ... | [] |
NCT05059600 | 12.1.4 | Oxygen Saturation | 12.1.4. Oxygen Saturation Participants will be monitored for hypoxia using continuous pulse oximetry equipped with an alarm. Oxygen saturation will only be recorded in the event of excessive sedation, loss of consciousness, hypoxia, or AESI. The infusion will be immediately stopped if pulse oximetry reveals hypoxia. Af... | [] |
NCT05059600 | 12.1.5 | Remote Monitoring of Oxygen Saturation and Vital Signs | 12.1.5. Remote Monitoring of Oxygen Saturation and Vital Signs In addition to local monitoring in the home, oxygen saturation and vital signs will also be remotely monitored continuously throughout the duration of the infusion using a wireless, | [] |
NCT05059600 | 12.1.6 | Monitoring for Excessive Sedation | 12.1.6. Monitoring for Excessive Sedation For the duration of the infusion, participants must be assessed for excessive sedation by a healthcare provider every 2 hours during planned nonsleep periods. If excessive sedation occurs at any time during the infusion, the infusion will be stopped until the symptoms resolve. ... | [] |
NCT05059600 | 12.1.7 | Suicidal Thoughts and Behaviors | 12.1.7. Suicidal Thoughts and Behaviors Participants should be counseled before the start of the ZULRESSO infusion to pay close attention to any changes related to suicidal thoughts or behaviors, especially sudden changes in mood, behavior, thoughts, or feelings; participants should tell the healthcare provider right a... | [] |
NCT05059600 | 12.1.8 | Pregnancy Screen | 12.1.8. Pregnancy Screen A urine pregnancy test will be conducted for all participants at screening; a urine pregnancy test will be conducted on Day 1 prior to the start of the infusion. | [] |
NCT05059600 | 12.1.9 | Nonadherence with the Safe-use Conditions for Administration of ZULRESSO | 12.1.9. Nonadherence with the Safe-use Conditions for Administration of ZULRESSO A secondary endpoint of this study is incidence of nonadherence with the safe-use conditions for administration of ZULRESSO. Nonadherence with safe-use conditions for administration of ZULRESSO in the home setting is defined by any of the ... | [] |
NCT05059600 | 12.1.10 | Daily and/or End-of-Shift Checklist/Journal | 12.1.10. Daily and/or End-of-Shift Checklist/Journal Throughout the duration of the infusion, home healthcare provider staff will complete checklists and/or journals at the end of each day and/or shift to document any use-related issues, including how the issues were addressed and followed-up. Any use-related issues de... | [] |
NCT05059600 | 12.1.11 | Post-infusion Interview of Home Healthcare Providers | 12.1.11. Post-infusion Interview of Home Healthcare Providers An HF team member will conduct a post-infusion remote interview (no more than 3 days after completion of the infusion) with the home healthcare provider to assess their comprehension of and compliance to processes and procedures and to identify potential pro... | [] |
NCT05059600 | 12.2 | Adverse and Serious Adverse Events | 12.2. Adverse and Serious Adverse Events | [] |
NCT05059600 | 12.2.1 | Adverse Event Definition | 12.2.1. Adverse Event Definition An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnorm... | [] |
NCT05059600 | 12.2.2 | Serious Adverse Event Definition | 12.2.2. Serious Adverse Event Definition An SAE is any untoward medical occurrence that at any dose: - Results in death - Places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death - Requires ... | [] |
NCT05059600 | 12.2.3 | Definition of Adverse Events of Special Interest | 12.2.3. Definition of Adverse Events of Special Interest An AESI is an AE/SAE of scientific and/or medical concern, specific to the product or program for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. Such adverse events normally require thorough documentation and inve... | [] |
NCT05059600 | 12.2.4 | Relationship to Investigational Product | 12.2.4. Relationship to Investigational Product The investigator must make the determination of relationship to the IP for each adverse event (not related, related). The following definitions should be considered when evaluating the relationship of AEs and SAEs to the IP. | Not Related | An AE will be considered "not r... | [] |
NCT05059600 | 12.2.5 | Recording Adverse Events | 12.2.5. Recording Adverse Events Adverse events spontaneously reported by the participant and/or in response to an open question from the study personnel or revealed by observation will be recorded during the study. The AE term should be reported in standard medical terminology when possible. For each AE, the investiga... | [] |
NCT05059600 | 12.2.6 | Reporting Serious Adverse Events | 12.2.6. Reporting Serious Adverse Events In order to adhere to all applicable laws and regulations for reporting an SAE(s), the investigator must notify Sage or designee within 24 hours of the study site staff becoming aware of the SAE(s). The investigator must complete, sign and date the SAE report form, verify the ac... | [] |
NCT05059600 | 12.3 | Pregnancy | 12.3. Pregnancy Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm. If a participant becomes pregnant after the first administration of IP, pregnancy information must be collected and recorded on the Pregnancy Form and submitted to the sponsor within 24... | [] |
NCT05059600 | 12.4 | Overdose | 12.4. Overdose Overdoses in the absence of clinical signs and symptoms should not be recorded as a separate AE on the eCRF; however, all overdoses must be recorded on an Overdose form and sent to Sage or designee within 24 hours of the site becoming aware of the overdose. An overdose must be reported to Sage or designe... | [] |
NCT05059600 | 12.5 | Medication Error | 12.5. Medication Error Medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. All medication errors must be recorded and sent to Sage or designee within 24 hours of the ... | [] |
NCT05059600 | 13 | STATISTICS | 13. STATISTICS Detailed description of the analyses to be performed in the study will be provided in the statistical analysis plan (SAP). The SAP will be finalized and approved prior to database lock. Any changes/additions to the SAP following database lock will be described in detail in the clinical study report. | [] |
NCT05059600 | 13.1 | Data Analysis Sets | 13.1. Data Analysis Sets The Safety Set will include all participants administered ZULRESSO. | [] |
NCT05059600 | 13.2 | Handling of Missing Data | 13.2. Handling of Missing Data Every attempt will be made to avoid missing data. All participants will be used in the analyses, as per the analysis populations, using all nonmissing data available. No imputation process will be used to estimate missing data. | [] |
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