protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT01673646 | 4.1 | Description of study design | 4.1 Description of study design A total of 30 eligible patients will be enrolled. The enrolled patients will be randomized to one of 3 doses of pasireotide LAR (20 mg, 40 mg, or 60 mg) in a ratio of 1:1:1. Randomization will be stratified by prior medications (e.g. somatostatin analogues, dopamine agonists or GH recept... | [] |
NCT01673646 | 4.2 | Timing of interim analyses and design adaptations | 4.2 Timing of interim analyses and design adaptations Not applicable | [] |
NCT01673646 | 4.3 | Definition of end of the study | 4.3 Definition of end of the study Completion of the study as a whole (last patient last visit) will occur after all patients have completed all assessments as per [Table 7-1](#page-49-0) and [Table 7-2](#page-52-0) (core and extension phase) or have discontinued early. | [] |
NCT01673646 | 4.4 | Early study termination | 4.4 Early study termination The study can be terminated at any time for any reason by Novartis. Should this be necessary, the patient should be seen as soon as possible and the same assessments should be performed as described in [Section 7.1.3](#page-55-0) for a prematurely withdrawn patient. The investigator may be i... | [] |
NCT01673646 | 5 | Population | 5 Population | [] |
NCT01673646 | 5.1 | Patient population | 5.1 Patient population The eligible patient population will consist of adult Japanese patients, with active acromegaly or pituitary gigantism. The investigator or designee must ensure that only patients who meet all the following inclusion and none of the exclusion criteria are offered study treatment in the study. | [] |
NCT01673646 | 5.2 | Inclusion criteria | 5.2 Inclusion criteria Patients eligible for inclusion in this study have to meet all of the following criteria: - 1. Written informed consent obtained prior to any screening procedures - 2. Male or female patients of at least 18 years of age - 3. Patients with active acromegaly or pituitary gigantism following a or b ... | [] |
NCT01673646 | 5.3 | Exclusion criteria | 5.3 Exclusion criteria Patients eligible for this study must not meet any of the following criteria: - 1. For patients with inadequately controlled acromegaly or pituitary gigantism with current medication. - Patients who have been treated with dopamine agonists during the last 8 weeks prior to visit 1 (screening). - P... | [] |
NCT01673646 | 6 | Study treatment | 6 Study treatment | [] |
NCT01673646 | 6.1 | Study treatment | 6.1 Study treatment Investigational study treatment: pasireotide LAR i.m. | [] |
NCT01673646 | 6.1.1 | Dosing regimen | 6.1.1 Dosing regimen Patient will receive one of three pasireotide LAR i.m. doses of 20, 40, or 60 mg. Intramuscular administration of pasireotide LAR will be repeated every month (1 month = 28 days) for 12 months in core phase. It is permitted to increase the dose up to 60 mg in a patient showing the following biochem... | [] |
NCT01673646 | 6.1.2 | Ancillary treatments | 6.1.2 Ancillary treatments Not applicable. | [] |
NCT01673646 | 6.1.3 | Rescue medication | 6.1.3 Rescue medication Not applicable. | [] |
NCT01673646 | 6.1.4 | Guidelines for continuation of treatment | 6.1.4 Guidelines for continuation of treatment Patients may continue treatment provided no tolerability issues are present (See [Section 6.3](#page-36-0)) and criteria for discontinuation are not met (see [Section 7.1.3\)](#page-55-0). | [] |
NCT01673646 | 6.1.5 | Treatment duration | 6.1.5 Treatment duration Patients will be treated for 12 months in the core phase of the study and will have the option to continue study treatment for 12 more months in the extension phase of the study. | [] |
NCT01673646 | 6.2 | Dose escalation guidelines | 6.2 Dose escalation guidelines Not applicable. | [] |
NCT01673646 | 6.3 | Dose modifications | 6.3 Dose modifications | [] |
NCT01673646 | 6.3.1 | Dose modification and dose delay | 6.3.1 Dose modification and dose delay
Dose up-titration Dose increases is permitted after the first three months of treatment (steady-state reached) if biochemical parameters show a mean GH level ≥ 2.5 µg/L and/or IGF-1 > ULN (age and sex related) and there are no tolerability issues (see [Table 6-1\)](#page-37-0). P... | [
"Dose up-titration",
"Dose down-titration",
"Dose interruption"
] |
NCT01673646 | 6.3.2 | Follow-up for toxicities | 6.3.2 Follow-up for toxicities Refer to [Table 6-2](#page-37-0), [Table 6-3](#page-37-0) and [Section 6.3.3.](#page-38-0) 2 Dose reduction below 20mg is prohibited .Dose reduction should be based on the worst toxicity demonstrated at the last dose. | [] |
NCT01673646 | 6.3.3 | Anticipated risks and safety concerns of the study drug | 6.3.3 Anticipated risks and safety concerns of the study drug Appropriate eligibility criteria, specific dose modification and stopping rules are included in this protocol. Recommended guidelines for prophylactic or supportive treatment for expected toxicities, including management of study-drug induced adverse events,... | [] |
NCT01673646 | 6.3.3.1 | Hyperglycemia | 6.3.3.1 Hyperglycemia Hyperglycemia is known to be associated with the treatment of somatostatin analogues (SSA). Clinical studies of pasireotide in healthy volunteers and in patients with Cushing's disease, acromegaly or carcinoid syndrome have reported transient, asymptomatic increases in fasting and postprandial glu... | [
"Monitoring of blood glucose"
] |
NCT01673646 | 6.3.3.2 | QT-related cardiology consultation / Holter monitoring | 6.3.3.2 QT-related cardiology consultation / Holter monitoring All patients will be asked to return on Day 22 for an ECG recording and PK sampling. If at any visit a QTcF > 500 msec is observed, triplicate ECGs, each 2-3 minutes apart, need to be taken approximately 1 hour after the initial ECG. The mean QTcF from the ... | [] |
NCT01673646 | 6.3.3.3 | Hepatic safety management | 6.3.3.3 Hepatic safety management If any of the criteria below are observed at any scheduled or unscheduled visit the sponsor should be notified immediately upon awareness. - ALT or AST > 3 x ULN and Total Bilirubin ≥ 2 x ULN - ALT or AST > 5 x ULN and ≤ 8 x ULN - ALT or AST > 8 x ULN The following should be performed ... | [] |
NCT01673646 | 6.4 | Concomitant medications | 6.4 Concomitant medications | [] |
NCT01673646 | 6.4.1 | Permitted concomitant therapy | 6.4.1 Permitted concomitant therapy The patient must be told to notify the investigational site about any new medications he/she takes after the start of the study drug. As well as any changes in the dose of any medication the patient was taking prior to or during the study. All medications (other than study drug) and ... | [] |
NCT01673646 | 6.4.2 | Permitted concomitant therapy requiring caution and/or action | 6.4.2 Permitted concomitant therapy requiring caution and/or action Investigators should discourage patients from taking any medication during the study, with the exception of medications that are required to treat an adverse event. | [] |
NCT01673646 | 6.4.3 | Prohibited concomitant therapy | 6.4.3 Prohibited concomitant therapy For patients with medication naïve acromegaly or pituitary gigantism the single dose of short acting octreotide or short-acting dopamine agonists should not be administered within 3 days prior to Visit2 (baseline). In case of a single dose of short-acting octreotide, the dose should... | [] |
NCT01673646 | 6.5 | Patient numbering, treatment assignment or randomization | 6.5 Patient numbering, treatment assignment or randomization | [] |
NCT01673646 | 6.5.1 | Patient numbering | 6.5.1 Patient numbering Each patient is identified in the study by a Patient Number (Patient No.), that is assigned when the patient is first enrolled for screening and is retained as the primary identifier for the patient throughout his/her entire participation in the trial. The Patient No. consists of the Center Numb... | [] |
NCT01673646 | 6.5.2 | Treatment assignment or randomization | 6.5.2 Treatment assignment or randomization | [] |
NCT01673646 | 6.5.2.1 | Randomization number | 6.5.2.1 Randomization number If the patient is deemed eligible for the study and will commence dosing, a randomization number will be assigned. Once assigned to a subject, a randomization number will not be reused. Patients who have prior medications will be assigned randomization numbers and patients who don't have pr... | [] |
NCT01673646 | 6.5.3 | Treatment blinding | 6.5.3 Treatment blinding This is an open-label study. However, in order to minimize the potential impact of treatment knowledge, treatment allocation, dose information and PK data will not be accessed by sponsor except data manager and CRA until it will be locked for the primary analysis. The investigators and patients... | [] |
NCT01673646 | 6.6 | Study drug preparation and dispensation | 6.6 Study drug preparation and dispensation Novartis supplies pasireotide LAR to the investigational sites as 20 mg and 40mg vials. All dosages given to the patient and all dose changes during the study must be recorded on the Dosage Administration Record CRF. Instructions for Use can be found in [Appendix 1.](#page-84... | [] |
NCT01673646 | 6.6.1 | Study drug packaging and labeling | 6.6.1 Study drug packaging and labeling Pasireotide LAR will be provided as powder for suspension in vials and solution for suspension ("vehicle") will be provided in ampoules. Medication labels will be in the local language and comply with the legal requirements of Japan. They will include storage conditions for the d... | [] |
NCT01673646 | 6.6.2 | Drug supply and storage | 6.6.2 Drug supply and storage Study treatments must be received by a designated personnel at the study site, handled and stored safely and properly, and kept in a secured location to which only the investigator and designated site personnel have access. Upon receipt, pasireotide LAR should be stored according to the in... | [] |
NCT01673646 | 6.6.3 | Study drug compliance and accountability | 6.6.3 Study drug compliance and accountability | [] |
NCT01673646 | 6.6.3.1 | Study drug compliance | 6.6.3.1 Study drug compliance Study drug compliance will be assessed by the Dosage Administration Record. All information is to be noted in the Dosage Administration Record. | [] |
NCT01673646 | 6.6.3.2 | Study drug accountability | 6.6.3.2 Study drug accountability The investigator or designee must maintain an accurate record of the shipment and dispensing of study treatment in a drug accountability log. Drug accountability will be noted by the field monitor during site visits and at the completion of the study. At study close-out, and, as approp... | [] |
NCT01673646 | 6.6.4 | Disposal and destruction | 6.6.4 Disposal and destruction The study drug supply can be destroyed at the local Novartis facility, Drug Supply group or third party, as appropriate. | [] |
NCT01673646 | 7 | Visit schedule and assessments | 7 Visit schedule and assessments 6.6.3.3 Handling of other study treatment | [] |
NCT01673646 | 7.1 | Study flow and visit schedule | 7.1 Study flow and visit schedule [Table 7-1](#page-49-0) and [Table 7-2](#page-52-0) list all of the assessments and indicate with an "X", the visits when they are performed. All data obtained from these assessments must be supported in the patient's source documentation. The table indicates which assessments produce ... | [] |
NCT01673646 | 7.1.1 | Screening | 7.1.1 Screening Screening examination (Visit 1) is to include the procedures found in [Table 7-1](#page-49-0) and should occur within 28 days prior to baseline. The informed consent must be signed prior to ANY screening procedure being performed. Patients that do not meet eligibility criteria are allowed to be rescreen... | [] |
NCT01673646 | 7.1.1.1 | Eligibility screening | 7.1.1.1 Eligibility screening Manual process: Patient eligibility will be checked by the Registration center once all screening procedures are completed. The eligibility check form will be sent from the site to the Registration center either via fax or email for evaluation. Upon confirmation of eligibility, the Registr... | [] |
NCT01673646 | 7.1.1.2 | Information to be collected on screening failures | 7.1.1.2 Information to be collected on screening failures Patients who sign an informed consent but fail to be started on treatment for any reason will be considered a screen failure. The reason for not being started on treatment will be entered on the Screening Log Page. The Demography, Informed consent eCRF pages mus... | [] |
NCT01673646 | 7.1.1.3 | Patient demographics and other baseline characteristics | 7.1.1.3 Patient demographics and other baseline characteristics Standard demographic information and medical history will be collected. Acromegaly or pituitary gigantism history and diabetes history together with the medication/treatment used will also be collected. Other baseline assessments will be collected as per [... | [] |
NCT01673646 | 7.1.2 | Treatment period | 7.1.2 Treatment period The treatment period in the core phase of the study will be 12 months. Patients will have monthly visits with some visits more frequently (see [Table 7-1\)](#page-49-0). All visits should be performed on the indicated days. In cases where this is not possible, the following visit windows apply: +... | [] |
NCT01673646 | 7.1.3 | End of treatment visit including study completion and premature withdrawal | 7.1.3 End of treatment visit including study completion and premature withdrawal Patients who discontinue study treatment before visit 777 (if patient is in the core phase of the study) or visit 33 (if patient is in the extension phase of the study), should be scheduled for a visit as soon as possible, at which time al... | [
"End of treatment visit and Study completion visit for patients treated for more than 2 years (after Visit 33)"
] |
NCT01673646 | 7.1.3.1 | Criteria for premature patient withdrawal | 7.1.3.1 Criteria for premature patient withdrawal Patients may voluntarily withdraw from the study or be dropped from it at the discretion of the investigator at any time. Patients may be withdrawn from the study if any of the following occur: - Adverse event(s) [including abnormal laboratory value(s) and abnormal test... | [] |
NCT01673646 | 7.1.4 | Follow up period | 7.1.4 Follow up period All patients must have safety evaluations for 56 days after the last dose of study treatment. Patients lost to follow up should be recorded as such on the eCRF. For patients who are lost to follow-up, the investigator should show "due diligence" by documenting in the source documents steps taken ... | [] |
NCT01673646 | 7.2 | Assessment types | 7.2 Assessment types | [] |
NCT01673646 | 7.2.1 | Efficacy assessments | 7.2.1 Efficacy assessments | [] |
NCT01673646 | 7.2.1.1 | GH (5-point mean GH level) | 7.2.1.1 GH (5-point mean GH level) Patients' 5-point mean GH level will be assessed from a 2-hour profile after one hour at rest at the hospital before pasireotide LAR injection (for details please refer to [Table 7-1](#page-49-0) and [Table](#page-52-0) [7-2](#page-52-0)). The scheduled time points for blood sampling ... | [] |
NCT01673646 | 7.2.1.2 | IGF-1 | 7.2.1.2 IGF-1 Patient's total IGF-1 levels will be assessed with one pre-dose sample at the same visits as GH (for details please refer to [Table 7-1](#page-49-0) and [Table 7-2](#page-52-0)). T0 is defined as time point immediately pre-dose with respect to pasireotide LAR injection. The samples for IGF-1 will be analy... | [] |
NCT01673646 | 7.2.1.3 | MRI | 7.2.1.3 MRI An MRI of the pituitary will be performed at visits indicated in [Table 7-1.](#page-49-0) MRI will not be performed during Extension phase. For de-novo patients an adenoma must be visible on screening MRI. The MRIs will be sent for evaluation by a central reader. To ensure consistency throughout all partici... | [] |
NCT01673646 | 7.2.1.4 | Symptoms of acromegaly or pituitary gigantism | 7.2.1.4 Symptoms of acromegaly or pituitary gigantism The investigator will measure the patient's ring size using the gauge at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) Ring size will be measured at the fourth digit of the non-dominant hand. In the case a patient has a fourth digit size e... | [] |
NCT01673646 | 7.2.1.5 | Prolactin (PRL) | 7.2.1.5 Prolactin (PRL) PRL levels will be assessed at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) T0 is defined as time point immediately pre-dose with respect to pasireotide LAR injection. The samples for PRL will be analyzed by the central laboratory, . Please refer to the for processing... | [] |
NCT01673646 | 7.2.2 | Safety and tolerability assessments | 7.2.2 Safety and tolerability assessments Safety will be monitored by assessing hematology (including coagulation parameters), Biochemistry (including fasting blood glucose, glycosylated hemoglobin, LFTs), fasting serum cortisol, plasma ACTH, liver and thyroid function tests, urinalysis, injection site reactions, physi... | [] |
NCT01673646 | 7.2.2.1 | Physical examination | 7.2.2.1 Physical examination A complete physical examination will be performed by the investigator at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) Information about the physical examination findings will be presented in the source documentation at the study site. Significant findings that we... | [] |
NCT01673646 | 7.2.2.2 | Vital signs | 7.2.2.2 Vital signs Blood pressure, heart rate and body temperature will be assessed at visits indicated in [Table 7-](#page-49-0) [1](#page-49-0) and [Table 7-2](#page-52-0) and recorded in the eCRF. Blood pressure and heart rate are to be taken after the patient has been in a supine position for 3 minutes. | [] |
NCT01673646 | 7.2.2.3 | Height and weight | 7.2.2.3 Height and weight Height in centimeters (cm) and weight to the nearest 0.1 kilogram (kg) are to be collected are to occur at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2](#page-52-0) and recorded in the appropriate eCRF. | [] |
NCT01673646 | 7.2.2.4 | Laboratory evaluations | 7.2.2.4 Laboratory evaluations Central laboratories will be used for the analysis of serum cortisol and ACTH evaluations. Details on the collections, shipment of samples and reporting of results by the central laboratory are to be provided to investigators in the [Laboratory Manual]. Patients are to fast overnight for ... | [] |
NCT01673646 | 7.2.2.4.1 | Hematology | 7.2.2.4.1 Hematology Hematology will be assessed locally at the site at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) Hematology will include: WBC count with differential, hemoglobin, hematocrit, RBC count and platelet count. | [] |
NCT01673646 | 7.2.2.4.2 | Coagulation | 7.2.2.4.2 Coagulation PT and activated partial thromboplastin time (APTT) will be assessed locally at the site at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) | [] |
NCT01673646 | 7.2.2.4.3 | Biochemistry | 7.2.2.4.3 Biochemistry Fasting biochemistry (including fasting blood glucose) will be assessed locally at the site at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) Albumin, Alkaline phosphatase (ALP), Total Bilirubin, ALT (SGPT), AST (SGOT), GGT, Calcium, Chloride, Magnesium, Potassium, Sodiu... | [] |
NCT01673646 | 7.2.2.4.4 | Liver function testing | 7.2.2.4.4 Liver function testing Presence of HBsAg and AntiHCV are to be assessed during screening. At Visit 8 (Day 50) a full chemistry panel is not required and only the following Liver chemistry tests (LFTs) will be measured: ALT, AST, total bilirubin, direct bilirubin, indirect bilirubin, Alb, ALP and GGT. If at an... | [] |
NCT01673646 | 7.2.2.4.5 | Serum cortisol | 7.2.2.4.5 Serum cortisol One pre-dose sample for fasting serum cortisol will be taken early in the morning at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2](#page-52-0) and assessed at the central laboratory. It is strongly recommended to take the sample for fasting serum cortisol between 7 and 9 am as thi... | [] |
NCT01673646 | 7.2.2.4.6 | ACTH | 7.2.2.4.6 ACTH A pre-dose blood draw for plasma ACTH sampling will be taken at visits indicated in [Table](#page-49-0) [7-1](#page-49-0) and [Table 7-2](#page-52-0) and assessed at the central laboratory. | [] |
NCT01673646 | 7.2.2.4.7 | Thyroid function tests | 7.2.2.4.7 Thyroid function tests Free T4 and TSH will be assessed at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) These tests will be performed and assessed locally at the site. | [] |
NCT01673646 | 7.2.2.4.8 | Urinalysis | 7.2.2.4.8 Urinalysis Specific gravity, pH, semi-quantitative "dipstick" evaluation of glucose, protein, bilirubin, ketones, leukocytes and blood will be assessed at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) | [] |
NCT01673646 | 7.2.2.4.9 | Pregnancy and assessments of fertility | 7.2.2.4.9 Pregnancy and assessments of fertility All pre-menopausal women who are not surgically sterile will have a serum hCG-β pregnancy test at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2.](#page-52-0) Note: Up to Visit 33, serum pregnancy test will be done and after Visit 33, serum or urine pregnancy... | [] |
NCT01673646 | 7.2.2.4.10 | Gallbladder ultrasound | 7.2.2.4.10 Gallbladder ultrasound A gallbladder ultrasound will be performed at the sites at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2](#page-52-0) and the results will be recorded in the eCRF. | [] |
NCT01673646 | 7.2.2.5 | Cardiac assessments | 7.2.2.5 Cardiac assessments | [] |
NCT01673646 | 7.2.2.5.1 | Electrocardiogram (ECG) | 7.2.2.5.1 Electrocardiogram (ECG) A 12-lead ECG and a rhythm strip will be performed in supine position at the sites at visits indicated in [Table 7-1](#page-49-0) and [Table 7-2](#page-52-0). All ECGs should include all 12 standard leads and a Lead II rhythm strip of at least a 10 second duration. The ECGs will be per... | [] |
NCT01673646 | 7.2.2.6 | Tolerability | 7.2.2.6 Tolerability In addition to general safety data, information on dose reductions will be collected. | [] |
NCT01673646 | 7.2.3 | Pharmacokinetics | 7.2.3 Pharmacokinetics To assess the pharmacokinetic profile of pasireotide administered as LAR, blood samples will be collected at the predefined time points ([Table 7-5](#page-62-0)) and plasma concentration of pasireotide will be measured. The time of blood collection will be recorded on the PK blood collection eCRF... | [] |
NCT01673646 | 7.2.3.1 | Pharmacokinetic blood sample collection and handling | 7.2.3.1 Pharmacokinetic blood sample collection and handling All blood samples will be taken by either direct venipuncture or indwelling cannula inserted in a forearm vein. 2.5 mL of blood will be collected into an EDTA tube to yield 1mL of plasma for analysis of pasireotide plasma concentration. Immediately after bloo... | [] |
NCT01673646 | 7.2.3.2 | Analytical method | 7.2.3.2 Analytical method Pasireotide plasma concentrations will be measured using a validated radio-immunoassay (RIA) with a lower limit of quantification (LLOQ) of at least 0.15 ng/mL (150 pg/mL). PK samples will be shipped to Atlanbio for bioanalysis.  | [] |
NCT01673646 | 7.2.5 | Other assessments | 7.2.5 Other assessments No additional tests will be performed on patients entered into this study. | [] |
NCT01673646 | 8 | Safety monitoring and reporting | 8 Safety monitoring and reporting | [] |
NCT01673646 | 8.1 | Adverse events | 8.1 Adverse events | [] |
NCT01673646 | 8.1.1 | Definitions and reporting | 8.1.1 Definitions and reporting An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained. Abnormal laboratory values or test results occurring after informed consent c... | [] |
NCT01673646 | 8.1.2 | Laboratory test abnormalities | 8.1.2 Laboratory test abnormalities | [] |
NCT01673646 | 8.1.2.1 | Definitions and reporting | 8.1.2.1 Definitions and reporting Laboratory abnormalities that constitute an Adverse event in their own right (are considered clinically significant, induce clinical signs or symptoms, require concomitant therapy or require changes in study treatment), should be recorded on the Adverse Events eCRF. Whenever possible, ... | [] |
NCT01673646 | 8.1.3 | Adverse events of special interest (optional) | 8.1.3 Adverse events of special interest (optional) Adverse events of special interest include but may not be limited to AE's related to the following preferred terms: arrhythmogenic potential, bradycardia, coagulation, constipation, diabetes insipidus, diarrhoea, gall bladder and biliary, GI bleeding, GH deficiency, h... | [] |
NCT01673646 | 8.1.3.1 | Definitions and reporting | 8.1.3.1 Definitions and reporting Groupings of adverse event of special interest will be considered and the number of patients with at least one event in each grouping will be reported. Such groups consist of AEs for which there is a specific interest in connection with SOM230 treatment (i.e. where SOM230 may influence... | [] |
NCT01673646 | 8.2 | Serious adverse events | 8.2 Serious adverse events | [] |
NCT01673646 | 8.2.1 | Definitions | 8.2.1 Definitions Serious adverse event (SAE) is defined as one of the following: - Is fatal or life-threatening - Results in persistent or significant disability/incapacity - Constitutes a congenital anomaly/birth defect - • Is medically significant, i.e., defined as an event that jeopardizes the patient or may requir... | [] |
NCT01673646 | 8.2.2 | Reporting | 8.2.2 Reporting To ensure patient safety, every SAE, regardless of suspected causality, occurring after the patient has provided informed consent and until at least 56 days after the patient has stopped study treatment must be reported to Novartis within 24 hours of learning of its occurrence. Any SAEs experienced afte... | [] |
NCT01673646 | 8.3 | Pregnancies | 8.3 Pregnancies To ensure patient safety, each pregnancy occurring while the patient is on study treatment must be reported to Novartis within 24 hours of learning of its occurrence. The pregnancy should be followed up to determine outcome, including spontaneous or voluntary termination, details of the birth, and the p... | [] |
NCT01673646 | 8.4 | Warnings and precautions | 8.4 Warnings and precautions No evidence available at the time of the approval of this study protocol indicated that special warnings or precautions were appropriate, other than those noted in the provided Investigator Brochure. Additional safety information collected between IB updates will be communicated in the form... | [] |
NCT01673646 | 9 | Data collection and management | 9 Data collection and management | [] |
NCT01673646 | 9.1 | Data confidentiality | 9.1 Data confidentiality Information about study subjects will be kept confidential and managed under the applicable laws and regulations. Those regulations require a signed subject authorization informing the subject of the following: - What protected health information (PHI) will be collected from subjects in this st... | [] |
NCT01673646 | 9.2 | Site monitoring | 9.2 Site monitoring Before study initiation, at a site initiation visit or at an investigator's meeting, Novartis personnel (or designated CRO) will review the protocol and eCRFs with the investigators and their staff. During the study, the field monitor will visit the site regularly to check the completeness of patien... | [] |
NCT01673646 | 9.3 | Data collection | 9.3 Data collection For studies using Electronic Data Capture (EDC), the designated investigator staff will enter the data required by the protocol into the Electronic Case Report Forms (eCRF). The eCRFs have been built using fully validated secure web-enabled software that conforms to 21 CFR Part 11 requirements, Inve... | [] |
NCT01673646 | 9.4 | Database management and quality control | 9.4 Database management and quality control For studies using eCRFs, Novartis personnel (or designated CRO) will review the data entered by investigational staff for completeness and accuracy. Electronic data queries stating the nature of the problem and requesting clarification will be created for discrepancies and mi... | [] |
NCT01673646 | 10 | Statistical methods and data analysis | 10 Statistical methods and data analysis In this study, the results will be reported several times. The first report is planned when the last patient completes 3 months assessment. The result of the primary endpoint will be summarized. On emerging safety concerns observed during the early study period, the second repor... | [] |
NCT01673646 | 10.1 | Analysis sets | 10.1 Analysis sets | [] |
NCT01673646 | 10.1.1 | Full Analysis Set | 10.1.1 Full Analysis Set The Full Analysis Set (FAS) comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients will be analyzed according to the study treatment they have been assigned to during the randomization procedure. | [] |
NCT01673646 | 10.1.2 | Safety Set | 10.1.2 Safety Set The Safety Set includes all patients who received at least one dose of study treatment. Patients will be analyzed according to the study treatment they actually received. A precise definition of "actually received" will be added in the RAP. | [] |
NCT01673646 | 10.1.3 | Per-Protocol Set | 10.1.3 Per-Protocol Set The Per-Protocol Set (PPS) consists of a subset of the patients in the FAS without any major protocol deviation and who received at least one dose of study treatment. Any protocol deviations leading to exclusion from the PPS will be detailed in the validation and planning (VAP) Module 3. | [] |
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