protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03329092 | 3 | STUDY DESIGN | This is a Phase 3, prospective, randomized, multicenter, open-label, central assessor-blinded (see Section 9.7), parallel group, comparative study to detennine the efficacy, safety, and tolerability of ATM-AVI ±MTZ versus MER ±COL in the treatment of hospitalized adults with cIAI or NP (including HAP and VAP) in region... | [] |
NCT03329092 | 4 | SUBJECT ELIGIBILITY CRITERIA | This study can fulfill its objectives only if appropriate subjects are enrolled. The following eligibility criteria are designed to select subjects for whom participation in the study is considered appropriate. All relevant medical and nonmedical conditions should be taken into consideration when deciding whether a par... | [] |
NCT03329092 | 4.1 | Inclusion Criteria | Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: | [] |
NCT03329092 | 4.1.1 | All Subjects | - 1. Subject must be ≥18 years of age.
- 2. Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study. If a subject is unable to consent for themselves at Screening, the subject's legally... | [] |
NCT03329092 | 4.1.2 | Additional Inclusion Criteria - cIAI Subjects | 1. Diagnosis of cIAI as:
Intra-operative/postoperative enrolment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis. Surgical intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery. Specimens fr... | [
"EITHER:",
"OR"
] |
NCT03329092 | 4.1.3 | Additional Inclusion Criteria – HAP/VAP Subjects | - 1. Onset of symptoms >48 hours after admission or 3 days).
- 2. New or worsening infiltrate on chest X-ray (or computerized tomography [CT] scan) obtained within 48 hours prior to randomization.
- 3. At least 1 of the following:
- Documented fever (temperature ≥38°C) or hypothermia (rectal/core temperature ≤35°C);
... | [] |
NCT03329092 | 4.2 | Exclusion Criteria | Subjects with any of the following characteristics/conditions will not be included in the study: | [] |
NCT03329092 | 4.2.1 | All Subjects | - 1. Subject has an APACHE II score >30.
- 2. At Screening the subject is found to have/or strongly suspected to have an infection caused by a Gram-negative species not expected to respond to either ATM-AVI and/or MER (eg, *Acinetobacter baumannii),* or an infection caused by only Gram-positive species. The subject is ... | [] |
NCT03329092 | 4.2.2 | Additional Exclusion Criteria – cIAI Subjects | - 1. Subject was diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within ≤24 hours. Other intra-abdominal processes in which the primary etiology is not likely to be infectious.
- 2. Subject has infections limited to the hollow viscou... | [] |
NCT03329092 | 4.2.3 | Additional Exclusion Criteria – HAP/VAP Subjects | - 1. APACHE II score For procedures for withdrawal of incorrectly enrolled subjects see Section 4.5. | [] |
NCT03329092 | 4.3 | Subject Enrolment and Randomization | Investigator(s) should keep a record, the subject screening log, of subjects who entered pre-study screening.
The Investigator will:
1. Obtain signed informed consent from the potential subject or their legally acceptable representative before any study specific procedures are performed. The subject is considered enr... | [] |
NCT03329092 | 4.4 | Randomization Criteria | All subjects being enrolled and fulfilling all eligibility criteria will be randomized in a 2:1 ratio to receive 1 of the 2 IV dosing regimens of either the ATM-AVI ±MTZ treatment arm (ie, test product) or the MER±COL treatment arm (ie, comparator). | [] |
NCT03329092 | 4.5 | Procedures for Handling Incorrectly Enrolled or Randomized Subjects | Subjects who fail to meet the eligibility criteria should not, under any circumstances, be randomized or receive study medication. There can be no exceptions to this rule. Subjects who are enrolled, but subsequently found not to meet all the eligibility criteria must not be randomized or initiated on treatment, and mus... | [] |
NCT03329092 | 4.6 | Lifestyle Requirements | [] | |
NCT03329092 | 4.6.1 | Contraception | All fertile male subjects and female subjects who are of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must agree to use a highly effective method of contraception consistently and correctly for the duration of the active treatment pe... | [] |
NCT03329092 | 4.7 | Sponsor's Qualified Medical Personnel | The contact information for the sponsor's appropriately qualified medical personnel for the study is documented in the study contact list located in the supporting study documentation. To facilitate access to appropriately qualified medical personnel on study-related medical questions or problems, subjects are provided... | [] |
NCT03329092 | 5 | STUDY TREATMENTS | For the purposes of this study, and per International Conference on Harmonisation (ICH) guidelines, investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference/comparator in a clinical trial, including a product with a marketing authorization when u... | [] |
NCT03329092 | 5.1 | Allocation to Treatment | All subjects being enrolled and fulfilling all eligibility criteria will be randomized.
Randomization will be performed using an IRT system. Specific information concerning the use of the IRT system will be provided in a separate user manual.
Block randomization using an IRT system will be used to randomize subjects ... | [] |
NCT03329092 | 5.2 | Methods for Ensuring Blinding | This is an open-label study. The Investigators, site personnel, and subjects will not be blinded in this open-label study; however, reasonable attempts by investigators and site personnel should be made to minimize bias wherever possible.
Clinical response outcome recorded at scheduled visits will be assessed by an in... | [] |
NCT03329092 | 5.3 | Methods for Unblinding | Only the independent adjudication committee members will be blinded during the study. They will not require unblinding. | [] |
NCT03329092 | 5.4 | Subject Compliance | The administration of all study drugs (including IPs) should be recorded in the appropriate sections of the CRF.
Qualified study center personnel will administer the IV study treatment and assure treatment compliance. At a minimum the dose, date, and exact start and stop time of administration of the IV study treatmen... | [] |
NCT03329092 | 5.5 | Investigational Product Supplies | [] | |
NCT03329092 | 5.5.1 | Dosage Forms and Packaging | The identity of the IP is provided in Table 2.
Table 2. Identity of Investigational Product
| Investigational product | Dosage form and strength |
|-------------------------|-------------------... | [] |
NCT03329092 | 5.5.2 | Labelling | Labels will be prepared in accordance with Good Manufacturing Practice (GMP) and local regulatory guidelines. The labels will fulfil GMP Annex 13 requirements for labelling (European Commission GMP Guideline 2010). Label text will be translated into local language.
Labels will be provided as either a single panel labe... | [] |
NCT03329092 | 5.5.3 | Preparation and Dispensing | See the IP manual and package insert for instructions on how to prepare the investigational product for administration. Investigational product should be prepared and dispensed by an appropriately qualified and experienced member of the study staff (eg, physician, nurse, physician's assistant, nurse practitioner, pharm... | [] |
NCT03329092 | 5.6 | Administration (Dose and Treatment Regimen) | The recommended minimal duration of treatment with IV study treatment is 5 days for cIAI and 7 days for HAP/VAP. The maximal duration of treatment is 14 days. | [] |
NCT03329092 | 5.6.1 | ATM-AVI ±MTZ Treatment Arm | ATM-AVI: Subjects will be given a loading dose and then an extended loading dose before commencing on a maintenance dose. All doses (loading, extended loading and maintenance), and the dosing frequency of the maintenance dose are dependent on renal function according to Table 3 below.
| Table 3. | ATM-AVIDoses in Rela... | [] |
NCT03329092 | 5.6.2 | MER ±COL Treatment Arm | Subjects will initially be given IV MER 1000 mg q8 h (with or without COL). However, if an MER-resistant pathogen is strongly suspected, COL (ie, colistimethate sodium) can also be initiated, and/or a dose of MER 2000 mg q8h can be used (given as an IV infusion over 3 hours), at the Investigator's discretion (Jaruratan... | [
"Meropenem (MER) (MERONEM SmPC):",
"Colistin (COL) (colistimethate sodium):"
] |
NCT03329092 | 5.6.3 | Optional Aminoglycosides | Subjects with HAP/VAP and proven or suspected co-infection with *Pseudomonas aeruginosa* may receive an optional IV aminoglycoside (eg, amikacin, gentamicin or tobramycin, based upon local practice and epidemiology) at the Investigators discretion to allow coverage for suspected or proven *Pseudomonas aeruginosa* infec... | [] |
NCT03329092 | 5.6.4 | Optional Gram-positive Antibiotics | Subjects with HAP/VAP may receive optional vancomycin or linezolid and subjects with cIAI may receive optional vancomycin, linezolid or daptomycin at the investigators discretion to provide antibiotic cover for a Gram-positive infection. The need for an adjunctive Gram-positive antibiotic should be re-evaluated once cu... | [] |
NCT03329092 | 5.6.5 | Changes in Renal Function during Study Treatment | In some subjects, the CrCL estimated from serum creatinine can rapidly recover (or deteriorate), especially early in the course of treatment for the infection. There is potential for accumulation of MTZ metabolites in ESRDsubjects, and therefore enhanced monitoring for MTZ associated AEs is recommended, and a dose redu... | [] |
NCT03329092 | 5.7 | Investigational Product Storage | The investigator or an approved representative, eg, pharmacist, will ensure that all investigational products including any comparator and/or marketed products are stored in a secured area with controlled access under required storage conditions and in accordance with applicable regulatory requirements.
Investigationa... | [] |
NCT03329092 | 5.8 | Investigational Product Accountability | The investigator site must maintain adequate records documenting the receipt, use, loss, or other disposition of the investigational product supplies. All investigational products will be accounted for using a drug accountability form/record.
The study treatment provided for this study will be used only as directed in... | [] |
NCT03329092 | 5.8.1 | Destruction of Investigational Product Supplies | The sponsor or designee will provide guidance on the destruction of unused investigational product (eg, at the site). If destruction is authorized to take place at the investigator site, the investigator must ensure that the materials are destroyed in compliance with applicable environmental regulations, institutional ... | [] |
NCT03329092 | 5.9 | Post Study Access to Study Treatment | At the end of the study, the sponsor will not continue to supply study drug to subjects or Investigators unless the sponsor chooses to extend the study. The Investigator should ensure that the subject receives appropriate standard of care to treat the condition under study. | [] |
NCT03329092 | 5.10 | Concomitant Treatment(s) | All prescription and over the counter medications being taken by the subject for the 2 weeks prior to the first dose of study medication (considered prior treatment) and from the first dose of study medication through the LFU visit (considered concomitant treatments) must be documented on the appropriate pages of the C... | [] |
NCT03329092 | 5.10.1 | Other Concomitant Treatment | Concomitant medication other than that described above, which is considered necessary for the subject's safety and well-being, may be given at the discretion of the Investigator and recorded in the appropriate sections of the CRF. | [] |
NCT03329092 | 5.11 | Drug-drug Interaction | [] | |
NCT03329092 | 5.11.1 | Aztreonam-avibactam | Drug-drug interactions with AVI are unlikely. The binding of AVI to human plasma proteins is very low and concentration-independent. AVI had negligible or no direct inhibitory effect on CYP isoenzymes in vitro; the negligible inhibition observed was at high concentration of AVI that exceed any clinically relevant expos... | [] |
NCT03329092 | 5.11.2 | Coagulation and Concomitant Use of Anticoagulants | Appropriate monitoring (according to applicable medical guidelines and institutional standard of care) should be unde1iaken when anticoagulants are prescribed conc01nitantly with antibiotics. Adjustments in the dose of oral anticoagulants may be necessaiy to maintain the desired level of anticoagulation. | [] |
NCT03329092 | 5.11.3 | Other Investigational Products | fufo1mation on DDis with other medicinal products and other fo1ms of interaction for protocol allowed antibiotics are available in the respective SmPCs for these products and fuvestigators ai·e recommended to refer to these for fmiher prescribing info1mation. | [] |
NCT03329092 | 6 | STUDY PROCEDURES | Study periods are defined in Figure 1. Details of the study plan and timing of procedures are provided in Schedule of Activities (Table 1).
Eve1y effo1i should be made to collect all the data, blood samples, and cultures and to complete all assessments required for each visit as detailed in the Schedule of Activities ... | [] |
NCT03329092 | 6.1 | Screening and Enrollment | Prior to any study specific procedures, subjects (or their legally acceptable representative if applicable) must provide written info1med consent. Enrollment/Screening procedures will be perfo1med according to the Schedule of Activities (Table 1). At Screening, subjects will be assessed regai·ding eligibility criteria.... | [] |
NCT03329092 | 6.1.1 | Visit 1: Eligibility/Screening Procedures (Day -1 to 1) | At Eligibility/Screening (Day -1 to 1), each potential subject (or his/her legally acceptable representative) will provide written info1med consent prior to staiiing any study-specific procedures.
Each subject will undergo Screening assessment procedures lessthan 24 hours prior to randoinization. Exceptions to this ai... | [] |
NCT03329092 | 6.2 | Study Period | [] | |
NCT03329092 | 6.2.1 | Visit 2: Baseline Procedures and Day 1 of Treatment (Day 1) | Procedures for visit 2 will vary depending on the timing of the visits 1 and 2 relative to surgery. Visit 2 may occur pre- or postoperatively in subjects with cIAI.
Local laboratory test results obtained at Visit 1 will be used to qualify subjects for inclusion (see Section 6.1.1). At Visit 2, safety lab samples (incl... | [] |
NCT03329092 | 6.2.2 | Visit 3 to 15: Ongoing Treatment (Days 2 to 14) | The recommended minimal duration of treatment in this study will be 5 days for cIAI and 7 days for HAP/VAP. The maximal duration of treatment will be 14 days. Subjects, who require continuation of IV study treatment after 5 days (cIAI) or 7 days (HAP/VAP), will continue to receive their IV study treatment by study cent... | [] |
NCT03329092 | 6.2.3 | Post-Treatment Period | [] | |
NCT03329092 | 6.2.3.1 | Visit 16: End of Treatment (Within 24 Hours after Last Infusion) | The following assessment procedures will be performed within 24 hours after the completion of the last infusion of IV study treatment:
- 1. Reviewing prior and concomitant medications (including prior and concomitant antibiotic treatment).
- 2. Performing complete physical examination as defined in Section 7.2.2.
- 3.... | [] |
NCT03329092 | 6.2.3.2 | Visit 17: Test of Cure (Day 28 ±3 days) | If it is not possible to perform the TOC on study Day 28, then the allowed visit window is Day 25 to 31.
The following assessment procedures will be performed at TOC:
- 1. Reviewing prior and concomitant medications (including antibiotic treatment).
- 2. Performing complete physical examination as defined in Section ... | [] |
NCT03329092 | 6.2.3.3 | Visit 18: Late Follow-up (Day 45±3 days) | If it is not possible to perform the LFU on study Day 45, then the allowed visit window is Day 42 to 48. If the subject has been discharged from hospital and is unable to return, the LFU visit can be conducted by telephone (with the permitted omission of the physical examination).
The LFU visit assessment procedures i... | [] |
NCT03329092 | 6.3 | Discontinuation of Investigational Product | Subjects may be discontinued from IP in the following situations:
- Condition under investigation resolved prior to minimum treatment period.
- Subject decision. The subject is at any time free to discontinue treatment, without prejudice to further treatment.
- Occurrence of an AE or any other condition posing a risk ... | [] |
NCT03329092 | 6.3.1 | Procedures for Discontinuation of a Subject from Investigational Product | At any time, subjects are free to discontinue IP or withdraw from the study (ie, IP and assessments – see Section 6.4), without prejudice to further treatment. A subject that decides to discontinue IP will always be asked about the reason(s) and the presence of any AEs. If possible, they will be seen and assessed by an... | [] |
NCT03329092 | 6.4 | Subject Withdrawal | Subjects may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the investigator or sponsor for safety (see also the Withdrawal From the Study Due to Adverse Events Section 8.1.3) or behavioral reasons, or the inability of the subject to comply with the p... | [] |
NCT03329092 | 6.4.1 | Screen Failures | Screening failures are subjects who do not fulfil the eligibility criteria for the study, and therefore must not be randomized. These subjects should have the reason for study withdrawal recorded as 'Screen failure' (the potential subject who does not meet one or more criteria required for participation in a study, thi... | [] |
NCT03329092 | 6.4.2 | Withdrawal of Consent | Subjects who request to discontinue receipt of study treatment will remain in the study and must continue to be followed for protocol specified follow-up procedures. The only exception to this is when a subject specifically withdraws consent for any further contact with him or her or persons previously authorized by th... | [] |
NCT03329092 | 6.4.3 | Lost to Follow-up | All reasonable efforts must be made to locate subjects to determine and report their ongoing status. This includes follow-up with persons authorized by the subject as noted above. Lost to follow-up is defined by the inability to reach the subject after a minimum of 2 documented phone calls, faxes, or e-mails as well as... | [] |
NCT03329092 | 7 | ASSESSMENTS | Every effort should be made to ensure that the protocol-required tests and procedures are completed as described. However, it is anticipated that from time to time there may be circumstances outside of the control of the investigator that may make it unfeasible to perform the test. In these cases the investigator will ... | [] |
NCT03329092 | 7.1 | Efficacy Assessments | [] | |
NCT03329092 | 7.1.1 | Clinical Response Assessment | Clinical response will be determined at the EOT and TOC visits as either cure, failure or indeterminate. The clinical response at each visit will be assessed by the Investigator, and subsequently validated by an independent adjudication committee that will be blinded to study treatment (see Section 9.7). Reason for fai... | [] |
NCT03329092 | 7.1.2 | Microbiological Response | For each pathogen identified at Baseline, microbiological outcome at EOT and TOC will be determined as shown in Table 10.
Table 10. Definition of Microbiological Response Categories at the EOT and TOC Visits, for Each Pathogen Identified at Initial/Pre Study (Study Qualifying) Culture
| Microbiologicalresponse ... | [] |
NCT03329092 | 7.1.2.1 | Microbiological Response Assessment | The per-subject and per-pathogen microbiological response at the EOT and TOC visits will be assessed based on the pathogen(s) isolated from the study qualifying baseline and post-baseline cultures per the definitions outlined below.
Microbiological response will be assessed separately for each pathogen after completio... | [
"Per-pathogen Microbiological Assessments after Completion of All Follow Up Visits",
"Per-subject (Overall) Microbiological Response Assessments",
"Per-resistance Type Microbiological Response Assessments",
"Emergent Infections"
] |
NCT03329092 | 7.2 | Safety Assessments | Safety and tolerability assessment will be undertaken on individual subject and cohort basis through a determination of SAEs and AEs based on signs and symptoms, examinations and laboratory tests. If deterioration in a laboratory value is associated with clinical signs and symptoms, the clinical diagnosis (or sign or s... | [] |
NCT03329092 | 7.2.1 | Laboratory Safety Assessments | Blood and urine samples for determination of clinical chemistry, hematology, and urinalysis will be taken at the times indicated in the Schedule of Activities (see Table 1 and Section 6).
Blood and urine samples collected for safety analyses will be sent to the central laboratory for analysis. The results of safety la... | [] |
NCT03329092 | 7.2.2 | Physical Examination | A complete physical examination will be performed as scheduled in the Schedule of Activities (Table 1) and include an assessment of the following: general appearance including site of infection, skin, head and throat (head, eyes, ears, nose, and throat), lymph nodes, respiratory, cardiovascular (CV), abdomen including ... | [] |
NCT03329092 | 7.2.3 | ECG | Standard 12-lead ECGs (triplicates for each recording time point) will be recorded and assessed at Baseline and Day 3 during the treatment period (see Table 1). The ECG on Day 3 should be performed at maximum plasma concentration (Cmax) which is immediately (within 30 minutes) after an infusionis completed.
The date o... | [] |
NCT03329092 | 7.2.4 | Vital Signs | Vital sign measurements (including BP, heart rate and body temperature) should be assessed at Screening, Baseline, daily (twice daily for body temperature) while the subject is receiving IV study treatment, at EOT and at TOC visits; for subjects with HAP/VAP, respiratory rate (breath per minute) and peripheral O2 satur... | [] |
NCT03329092 | 7.2.4.1 | Pulse and Blood Pressure | Supine BP and heart rate should be measured using a semiautomatic BP recording device with an appropriate cuff size or by direct measurement via arterial catheter. The subjects will be required to rest in a supine position for at least 10 minutes prior to heart rate and BP measurements. | [] |
NCT03329092 | 7.2.4.2 | Body Temperature | Body temperature will be measured using an automated thermometer. The subject's body temperature will be evaluated at least twice a day (suggested at least 8 hours apart) and the actual time of body temperature collection will be recorded. Fever will be defined as a body temperature ≥38°C. For each individual subject, ... | [] |
NCT03329092 | 7.2.5 | Pregnancy Testing | For female subjects of childbearing potential, a serum or urine pregnancy test, with sensitivity of at least 25 mIU/mL for β-hCG will be performed locally at screening (Visit 1). A negative pregnancy test result is required before the subject may receive the investigational product. Pregnancy tests will also be done wh... | [] |
NCT03329092 | 7.2.6 | Other Safety Assessments | [] | |
NCT03329092 | 7.2.6.1 | Chest X-ray/ CT Scan | For HAP/VAP subjects only, a chest X-ray or a CT scan will be taken at Screening (if not available within 48 hours prior to randomization), and as clinically indicated during the study (see Table 1). | [] |
NCT03329092 | 7.2.6.2 | Acute Physiology and Chronic Health Evaluation | At Screening, cIAI and HAP/VAP subjects will be assessed by using the Acute Physiology and Chronic Health Evaluation (APACHE) II score (see Appendix 5). Subjects with cIAI will also be stratified at randomization based on APACHE score. ABGs will be collected at Screening to calculate APACHE II score (see Table 1) as re... | [] |
NCT03329092 | 7.3 | Microbiology | Cultures of abdominal site infections (for cIAI subjects only)
Specimens must be obtained for culture from an initial qualifying surgical procedure performed within 24 hours before or after randomization and sent to the local laboratory for microbiological culture. This will be treated as the baseline culture.
Additi... | [
"Respiratory specimen for Gram-stain/culture (for HAP/VAP subjects only)",
"Collection of Blood for Culture (for all subjects)"
] |
NCT03329092 | 7.4 | Pharmacokinetics | PK sampling will be employed to achieve further information on the PK of ATM-AVI in the subject population. | [] |
NCT03329092 | 7.4.1 | Collection of Plasma Samples for Analysis of Aztreonam-Avibactam | A total of 6 blood samples (2 mL/sample to provide approximately 1.0 mL of plasma) for PK and/or PK/PD evaluation should be collected into appropriately labeled tubes containing sodium fluoride/potassium oxalate (gray top) from subjects assigned to the ATM-AVI ±MTZ treatment arm. Samples will be collected from the subj... | [] |
NCT03329092 | 7.4.2 | Determination of Drug Concentration | Samples for determination of ATM and AVI concentration in plasma will be analyzed using an appropriate validated bioanalytical method in compliance with Pfizer & vendor standard operating procedures (SOPs). Full details of the bioanalytical methods used will be described in a separate bioanalytical report.
The PK samp... | [] |
NCT03329092 | 7.4.3 | Storage and Destruction of Pharmacokinetic Samples | PK samples will be disposed of 12 months after the Bioanalytical Report finalization unless requested for future analyses.
Any residual back-up PK samples may be used for future CCI (in this case, residual back-up PK samples will be shipped to Sponsor assigned biostorage; see details in the Laboratory Manual). This is... | [] |
NCT03329092 | 7.5 | Pharmacogenomics: not applicable | Pharmacogenomics samples will not be taken during the study. | [] |
NCT03329092 | 7.6 | Biological Samples | The subject's consent to the use of donated biological samples is mandatory. Optional CCI samples will utilize the PK samples, so no additional draw of blood is needed. Samples for safety, microbiological and PK analyses will be collected as per the inclusion criteria, Schedule of Activities (Table 1) and PK sampling s... | [] |
NCT03329092 | 7.6.1 | Storage, Re-use and Destruction of Biological Samples | Samples will be stored until the end of the study and then destroyed; unused PK samples (with consent) will be stored for up to 15 years for CCI analysis; microbiology isolates will be kept at least five years after the study drug is submitted to the regulatory authorities for marketing approval. | [] |
NCT03329092 | 7.6.2 | Labelling and Shipment of Biological Samples | The Principal Investigator ensures that samples are labelled and shipped in accordance with the Laboratory Manual and the Biological Substance, Category B Regulations (materials containing or suspected to contain infectious substances that do not meet Category A criteria), see Appendix 2 'International Airline Transpor... | [] |
NCT03329092 | 7.6.3 | Chain of Custody of Biological Samples | A full chain of custody is maintained for all samples throughout their lifecycle.
The Investigator at each center keeps full traceability of collected biological samples from the subjects while in storage at the center until shipment or disposal (where appropriate) and keeps documentation of receipt of arrival.
The s... | [] |
NCT03329092 | 8 | ADVERSE EVENT REPORTING | [] | |
NCT03329092 | 8.1 | Requirements | The table below summarizes the requirements for recording safety events on the CRF and for repo1iing safety events on the Clinical Trial (CT) Serious Adverse Event (SAE) Repo1i Fo1m to Pfizer Safety. These requirements are delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposur... | [] |
NCT03329092 | 8.1.1 | Additional Details on Recording Adverse Events on the CRF | All events detailed in the table above will be recorded on the AE page(s) of the CRF. It should be noted that the CT SAE Report Form for reporting of SAE information is not the same as the AE page of the CRF. When the same data are collected, the forms must be completed in a consistent manner. AEs should be recorded us... | [] |
NCT03329092 | 8.1.2 | Eliciting Adverse Event Information | The investigator is to record on the CRF all directly observed AEs and all AEs spontaneously reported by the study subject/legally acceptable representative. In addition, each study subject/legally acceptable representative will be questioned about the occurrence of AEs in a non-leading manner. | [] |
NCT03329092 | 8.1.3 | Withdrawal from the Study Due to Adverse Events (see also the Subject Withdrawal Section) | Withdrawal due to AEs should be distinguished from withdrawal due to other causes, according to the definition of AE noted below, and recorded on the CRF.
When a subject withdraws from the study because of an SAE, the SAE must be recorded on the CRF and reported, as appropriate, on the CT SAE Report Form, in accordanc... | [] |
NCT03329092 | 8.1.4 | Time Period for Collecting AE/SAE Information | The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each subject begins from the time the subject provides informed consent, which is obtained before the subject's participation in the study (ie, before undergoing any study-related procedure and/or receiving investigation... | [] |
NCT03329092 | 8.1.4.1 | Reporting SAEs to Pfizer Safety | All SAEs occurring in a subject during the active collection period are reported to Pfizer Safety on the CT SAE Report Form.
SAEs occurring in a subject after the active collection period has ended are reported to Pfizer Safety if the investigator becomes aware of them; at a minimum, all SAEs that the investigator bel... | [] |
NCT03329092 | 8.1.4.2 | Recording Non-serious AEs and SAEs on the CRF | During the active collection period, both non-serious AEs and SAEs are recorded on the CRF.
Follow-up by the investigator may be required until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.
Any AEs/SAEs that are unresolved at the sub... | [] |
NCT03329092 | 8.1.5 | Causality Assessment | The investigator's assessment of causality must be provided for all AEs (serious and non-serious); the investigator must record the causal relationship on the CRF, and report such an assessment in accordance with the SAE reporting requirements, if applicable. An investigator's causality assessment is the determination ... | [] |
NCT03329092 | 8.1.6 | Sponsor's Reporting Requirements to Regulatory Authorities | AE reporting, including suspected unexpected serious adverse reactions, will be carried out in accordance with applicable local regulations. | [] |
NCT03329092 | 8.2 | Definitions | [] | |
NCT03329092 | 8.2.1 | Adverse Events | An AE is any untoward medical occurrence in a study subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Examples of AEs include, but are not limited to:
- Abnormal test findings;
- Clinically significant signs and symptoms;
- Changes ... | [] |
NCT03329092 | 8.2.2 | Abnormal Test Findings | Abnormal objective test findings should be recorded as AEs when any of the following conditions are met:
- Test result is associated with accompanying symptoms; and/or
- Test result requires additional diagnostic testing or medical/surgical intervention; and/or
- Test result leads to a change in study dosing (outside ... | [] |
NCT03329092 | 8.2.3 | Definitions of Serious Adverse Events | A serious adverse event is any untoward medical occurrence at any dose that:
- Results in death;
- Is life-threatening (immediate risk of death);
- Requires inpatient hospitalization or prolongation of existing hospitalization;
- Results in persistent or significant disability/incapacity (substantial disruption of the... | [] |
NCT03329092 | 8.2.4 | Hospitalization | Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility, or any prolongation of an existing admission. Admission also includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric wing to a medical floor, medical flo... | [] |
NCT03329092 | 8.3 | Severity Assessment | | | If required on the AE page of the CRF, the investigator will use the adjectives MILD, | |
|---------------------|---------------------------------------------------------------------------------------|-----------------------------------------|
| MODERATE, ... | [] |
NCT03329092 | 8.4 | Special Situations | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.