Participants with a personal or family history of long QT syndrome
Participants with a personal or family history of long QT syndrome
Participants with a personal or family history of long QT syndrome.
History of personal psoriasis.
Personal history of endometrial cancer or any abnormal uterine bleeding
Family or personal history of long QT syndrome
Personal history of Gilbert’s syndrome
Personal or family history of bleeding diathesis and a coagulation profile that would preclude patient from undergoing a neurosurgical procedure
Personal or family history of severe sickle cell disease or variant (unless donor has tested negative); testing for the presence of hemoglobin S is not required
Patients with personal or family history of bleeding disorders are not eligible
Personal or family history of long QT syndrome
Known personal history of >3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) >2 centimeters (cm) in size
Personal or family history of long QT syndrome
Personal or family history of established Brugada syndrome; if pre-enrollment electrocardiogram (ECG) demonstrates abnormal findings (ST elevation in precordial leads), cardiology consultation should be obtained to rule out presence of this inherited syndrome; patients with family history of unexplained sudden death before the age 45 years; personal history of unexplained syncope or history of unexplained ventricular tachycardia or fibrillation should have a cardiology evaluation to rule out the diagnosis of Brugada syndrome
Personal or family history of long QT syndrome
History of clinically significant cardiac disease, including but not limited to a history (personal or family) of congenital long QT syndrome
Subjects must have a personal mobile device compatible for the activity monitor
A personal history of colorectal cancer
Documented wish against transfusion for personal or religious beliefs
Personal history of migraine, cluster or tension headaches
Individuals who have a personal history of hereditary breast or ovarian cancer\r\n* A subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis
Personal history of an eating disorder
A personal history of cancer, tumor, or a related illness
Unwilling to use personal phone/tablet to test intervention
Personal history of ovarian cancer
Must be willing to complete demographic, family history, personal health and medication history, and informed consent
Known personal history of prostate cancer
Individuals that have a personal or family history of CRC (previous adenomatous polyp), and/or, have a signs and symptoms colonoscopy order from their primary care physician
Personal or family history (1st degree relative) of colon cancer
WHITE, NON-HISPANIC: Without a personal history of melanoma.
H/L: Without a personal history of melanoma and without a personal history of more than one squamous cell carcinoma (SCC) and/or basal cell carcinoma (BCC).
H/L: Participants with a personal history of melanoma and/or more personal history of more than one SCC and/or BCC.
Have a personal history of melanoma and/or family history of melanoma (see definition under child eligibility criteria below)
Personal history of polyps
Personal history of CRC
Personal or family history of porphyrias
Personal or family history of porphyrias
Personal or family history of porphyrias
Personal history of hepatitis or other liver diseases
A personal history of CRC
Ability to understand and the willingness to use the PMSA on the patient’s personal smartphone
Personal phone with SMS text messaging capability
A personal email address
No known history of prolonged QT syndrome
Participant has long QT Syndrome at screening.
Patients with a prior history of drug-induced serotonin syndrome, or a family history of long-QT syndrome
Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome
History of risk factors for TdP, including family history of long QT syndrome.
History or family history of long QT syndrome.
History of long-QT syndrome
Subjects with Long QT Syndrome at Screening.
Clinically significant cardiac abnormalities including QRS duration of >120 msec; QTcF >470 msec for women and >450 msec for men; Abnormal cardiac rhythm; Clinically significant cardiac valve abnormality; Documented history of left ventricular ejection fraction <0.30 within 6 months; Permanent pacemaker or automatic implantable cardioverter defibrillator; History of torsades de pointes, congenital long QT syndrome, or family history of long QT syndrome or sudden death
History of long QT syndrome or a family member with this condition
Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome
Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong the QT/QTc interval
Long QT Syndrome
Subject with a history of Long QT Syndrome at screening.
At increased risk for developing prolonged QT interval, including hypokalemia or hypomagnesemia, unless corrected to within normal limits prior to first dose of SNX-5422; congenital long QT syndrome or a history of torsade de pointes; currently receiving anti-arrhythmics or other medications that may be associated with QT prolongation.
History of risk factors for TdP, including family history of long QT syndrome
Long QT syndrome or a known family history of long QT syndrome
Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome
Subject is known to have long QT syndrome.
Patients with a history of long-QT syndrome or documented family history of long-QT syndrome; patients who must remain on drugs that prolong the QT interval
Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval.
At increased risk for developing prolonged QT interval, including hypokalemia or hypomagnesemia, unless corrected to within normal limits prior to first dose of SNX-5422; congenital long QT syndrome or a history of torsade de pointes; currently receiving anti-arrhythmics or other medications that may be associated with QT prolongation
Congenital long QT syndrome, prolonged QT interval, or family history of sudden unexplained death or long QT syndrome
Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
History of long QT syndrome.
Familial short QT syndrome
Grade 3 or higher recent (within the past 6 months) or ongoing cardiac dysrhythmias, family history of long QT syndrome, or serum potassium < 3.0 mEq/L that is persistent and refractory to correction
QTCF > 450 ms, inability to measure QT interval on ECG, personal or family history of long QT syndrome, requirement for medications that have the potential to prolong the QT interval
Subject has a history (or family history) of long QT syndrome.
A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation/flutter will be allowed on study
History of, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec] or concurrent treatment with any medication that prolongs QT interval).
Subject with Long QT Syndrome.
History of Brugada syndrome, risk factors for TdP, or family history of long QT syndrome.
Must have no congenital heart disease
Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
Patients with congenital long QT syndrome
Congenital long QT syndrome
History of congenital long QT syndrome or torsades de pointes
Congenital long QT syndrome
Patients with congestive heart failure, congenital long QT syndrome; bradyarrhythmias, drugs known to prolong the QT interval
Absence of history of congenital long QT syndrome
Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome.
Congenital long QT syndrome or family history of unexpected sudden cardiac death
Any history of congenital long QT syndrome
Known congenital long QT syndrome
History of congenital long QT syndrome or torsades de pointes
Congenital long QT syndrome
Diagnosed congenital long QT syndrome
Clinically significant electrocardiogram (ECG) changes at enrollment which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome.
History of congenital long QT syndrome
History of congenital long QT syndrome
Congenital long QT syndrome
Known family history of congenital long QT syndrome.
Patients with congenital long QT syndrome
Diagnosed congenital long QT syndrome
Congenital long QT syndrome
QTcF >470 msec on screening ECG or congenital long QT syndrome
History of congenital long QT syndrome or torsades de pointes
Congenital long QT syndrome or history of torsades de pointes
Clinically significant cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome
Congenital long QT syndrome
Patients with congenital long QT syndrome are excluded
Congenital long QT syndrome or family history of long QT syndrome
Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, and etc.
Congenital long QT syndrome.
Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
Congenital long QT syndrome or taking drugs known to prolong the QT interval
Diagnosed or suspected congenital long QT syndrome
QTcF >470 msec on screening ECG or congenital long QT syndrome
Diagnosed or suspected congenital long QT syndrome
Congenital long QT syndrome
Diagnosed or suspected congenital long QT syndrome.
Resting heart rate <50 bpm or > 90 bpm Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
Patients with congenital long QT syndrome are excluded from this study
Diagnosed or suspected congenital long QT syndrome
Patients with a family history of congenital long QT syndrome
Congenital long QT syndrome or a known family history of long QT syndrome
Patients with congenital long QT syndrome
Diagnosed congenital long QT syndrome
Congenital long QT syndrome
Patients with QTcF >470 msec at screening ECG or congenital long QT syndrome
QTcF >480 msec on screening ECG or congenital long QT syndrome
Congenital long QT syndrome.
Patients with congenital long QT syndrome
Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
Patients with congenital prolonged QT syndrome
Congenital long QT syndrome
Congenital long QT syndrome
History of congenital long QT syndrome or congenital short QT syndrome
Congenital long QT syndrome
Congenital long QT syndrome or family history of unexpected sudden cardiac death.
Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome
Diagnosed or suspected congenital long QT syndrome
Congenital long QT syndrome or family history of unexpected sudden cardiac death
History of congenital long QT syndrome or QTc > 450 ms
Diagnosed or suspected congenital long QT syndrome;
Patients with congenital long QT syndrome
Congenital long QT syndrome or a known family history of long QT syndrome
Participants may not have any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value\r\n* No history of QT prolongation associated with other medications that required discontinuation of that medication\r\n* Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval\r\n* Symptomatic heart failure – New York Heart Association (NYHA) grade II-IV
Any of the following cardiac criteria:\r\n* Resting corrected QT interval (QTc) > 480 msec obtained from electrocardiogram (ECG)\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) eg, complete left bundle branch block, third degree heart block\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval\r\n* Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade >= 2\r\n* Uncontrolled hypotension – systolic blood pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg\r\n* Left ventricular ejection fraction (LVEF) below lower limit of normal for site
Patients with QTc interval > 450 msecs or other factors that increase the risk of QTc prolongation or arrhythmic events (ex. heart failure, clinically significant hypokalemia, clinically significant hypomagnesemia, family history of long QT syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
Any factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, or any concomitant medication known to the prolong the QT interval that a patient is unable to stop
Subjects with corrected QT using Fridericia's formula (QTcF) interval of >= 450 msec if male and >= 470 msec if female; other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, chronic hypokalemia, family history of long QT interval syndrome) at screening; subjects with bundle branch block should be reviewed by the principal investigator for potential inclusion
Significant medical history or unstable medical comorbidities, including:\r\n* Heart disease including congestive heart failure (New York Heart Association [NYHA] grade II or greater); unstable angina; prior myocardial infarction (non-ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]) within 6 months prior to study enrollment; hypertension with a systolic blood pressure of > 150 mm Hg or diastolic blood pressure of > 100 mm Hg while on antihypertensive medication\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g. complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 msec, mean resting corrected QT value (QTc) of > 470 msec\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, or any concomitant medication known to the prolong the QT interval that a patient is unable to stop\r\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\r\n* Active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol\r\n* Active infection or ongoing antiviral medication for viral infections including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); screening for chronic conditions is not required; HIV-positive participants on combination antiretroviral therapy are ineligible
Patients with QTc interval > 450 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
QTc prolongation >450 ms or other factors that increase the risk for QT interval prolongation (e.g., heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], family history of long QT interval syndrome, or concomitant use of medications that may prolong QT interval)
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
Any factors that increase the risk of QTc prolongation or risk of rrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
Medications with a known risk of prolongation of QT interval
No congenital long QT syndrome or known 1st degree relative with unexplained sudden death under 40 years of age
Corrected QT (QTc) interval (i.e., Friderica’s correction [QTcF]) >= 450 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening
Any of the following cardiac abnormalities or history:\r\n* Mean resting corrected QT interval (QTc) > 470 msec, obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
Any of the following cardiac criteria: \r\n* Mean resting corrected QT interval (QTc using Fridericia's formula) > 470 msec;\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250msec;\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
QTc interval using Fridericia's formula (QTcF) ?450 msec or other factors that increase the risk of QT interval prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome). Bundle branch block and prolonged QTc are permitted with approval of the study Sponsor
Patients with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) that meets New York Heart Association (NYHA) class II or above
Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension, (see Table 1). Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.
Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT. syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age
History of risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome); concomitant use of medications with a low risk of QT/QTc prolongation (including, but not limited to diphenhydramine, famotidine, ondansetron) is permissible
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
QT prolongation and/or familiar history of QT prolongation and uncontrolled cardiac arrhythmias
Any of the following cardiac criteria\r\n* Resting corrected QT interval (QTc using Fridericia’s formula) > 480 msec\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograph (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval \r\n** Symptomatic congestive heart failure or left ventricular ejection fraction (LVEF) < 50%
known and possible risk for QT prolongation
Mean corrected QT interval (QTc) > 480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in a next-of-kin relative.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
History of QT prolongation associated with other medications that required discontinuation of that medication
Any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (Fridericia's correction formula [QTcF]) > 470 ms ms obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived corrected QT (QTc) value\r\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
Any factor increasing the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives, or any concomitant medication known to prolong the QT interval.
Any of the following cardiac criteria: Mean resting QT interval corrected for heart rate (QTc) more than 470 msec, obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
Patients must not have a mean resting corrected QT interval (QTc) > 450 msec obtained from 3 consecutive electrocardiograms (ECGs); performed within 28 days prior to sub-study registration; patients must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); patients must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age
Patients must not have a mean resting corrected QT interval (QTc) > 450 msec obtained from 3 consecutive electrocardiograms (ECGs); performed within 28 days prior to Step 2 re-registration; patients must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); patients must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age
Subjects with heart-rate corrected QT (QTc) interval ?450 ms or other factors that increase the risk of QT prolongation or arrhythmic events.
Patients with QTc interval ?450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome)
Clinically significant ECG abnormalities or any factors that increase the risk of corrected QT interval prolongation or risk of arrhythmic events
Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation or risk of arrhythmic events (such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age)
Patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 2 cardiac arrhythmias may be considered for inclusion if the arrhythmias are stable, asymptomatic, and unlikely to affect patient safety; patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade >= 3, corrected QT interval (QTc) prolongation > 450 ms, or other factors that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia [defined as serum potassium < 3.0 mEq/L that is persistent and refractory to correction], or family history of long QT interval syndrome)
Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital or familial long QT syndrome or family history of unexplained sudden death under 40 years of age or any concomitant medications known to prolong QT interval.
Subjects with heart-rate corrected QT (QTc) interval ? 450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome). Subjects with right bundle branch block and a prolonged QTc interval should be reviewed by the Medical Monitor for potential inclusion.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval.
Subjects with heart-rate corrected QT (QTc) interval ?450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening.
No clinical evidence of heart failure or history of untreated ejection fraction below the lower limit of normal per institutional standards, or significant QT prolongation (> grade 1, 480 msec) no history of congenital long QT syndrome, and no use of drugs known to increase the risk of torsades de point - patients may be eligible for study if the drug can be changed to another agent with less risk
QT related exclusion criteria:\r\n* QT interval corrected using Fridericia’s formula (QTcF) at screening > 470 msec\r\n* History of syncope or family history of idiopathic sudden death\r\n* Sustained or clinically significant cardiac arrhythmias\r\n* Risk factors for torsades de pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade atrioventricular (AV) block\r\n* Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), human immunodeficiency virus (HIV), cirrhosis, uncontrolled hypothyroidism or cardiac failure\r\n* Concomitant medication(s) known to increase the QT interval
Impaired cardiac function including ongoing cardiac dysrhythmias of grade > 2, ejection fraction < 50%, atrial fibrillation of any grade, or corrected QT (QTc) prolongation > 450 ms, or other factors that increase the risk of QT prolongation (i.e. family history of long QT interval syndrome, hypokalemia defined as serum potassium < 3.0 mEq/L)
Patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 2 cardiac arrhythmias may be considered for inclusion if the arrhythmias are stable, asymptomatic, and unlikely to affect patient safety; patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade >= 3, corrected QT interval (QTc) prolongation > 450 ms, or other factors that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia [defined as serum potassium < 3.0 mEq/L that is persistent and refractory to correction], or family history of long QT interval syndrome)
Heart-rate corrected QT (QTc) interval >450 msec or with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome). Subjects with right bundle branch block and a prolonged QTc interval should be reviewed by the Medical Monitor for potential inclusion
Patients with a corrected QT interval (QTc) at baseline of > 450 milliseconds or other factors that increase the risk of QT prolongation or arrhythmic events (i.e., heart failure, hypokalemia with potassium < 3.5 despite supplementation, family history of long QT syndrome) should be excluded
Known history of QT prolongation or is taking any medication known to lead to QT prolongation
Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age
Cardiovascular disease, including recent history of or currently clinically symptomatic and uncontrolled congestive heart failure, arrhythmia, angina, corrected QT (QTc) prolongation or other QTc risk factors, myocardial infarction; patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 2 cardiac arrhythmias may be considered for inclusion if the arrhythmias are stable, asymptomatic, and unlikely to affect patient safety; patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade >= 3, corrected QT interval (QTc) prolongation > 450 ms, or other factors that increase the risk for QT interval prolongation (e.g., heart failure, hypokalemia [defined as serum potassium < 3.0 mEq/L that is persistent and refractory to correction], or family history of long QT interval syndrome)
Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age;
Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation
Has any factors that increase the risk of corrected QT (QTc) interval prolongation or risk of arrhythmic events, such as congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation or risk of arrhythmic events (such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age)
QTc > 480 msec (based on the mean value of the triplicate electrocardiography [ECG]s), family or personal history of long or short QTc prolongation, or torsade de pointes (Tdp)
Patients with prior history of QTC prolongation or QTC > 450 ms on screening ECG will be excluded
Corrected QT interval (QTc) using Fridericia's formula (QTcF) value > 480 msec at Screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at Screening; previous history of drug induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG).
QTc >480 msec, or family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
Consistent corrected QT (QTc) > 470 msec on more than one screening electrocardiography (ECG). Patients with a history of long QTc syndrome or personal or family history of ventricular arrhythmias will be excluded.
Consistent corrected QT (QTc) > 470 msec on more than one screening electrocardiograms (ECGs); patients with a history of long QTc syndrome or personal or family history of ventricular arrhythmias will be excluded
Corrected QT interval (QTc) using Fridericia's formula (QTcF) value > 480 msec at Screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at Screening; previous history of drug induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG).
Corrected QT interval using Fridericia’s formula value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG)
Family history of long QTc syndrome; personal history of long QTc syndrome or previous drug-induced QTc prolongation of at least Grade 3 (QTc >500 ms).
Known family or personal history of long corrected QT (QTc) syndrome or ventricular arrhythmias including ventricular bigeminy
Corrected QT interval (QTc) value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (EKG); if QTc prolongation on screening EKG is felt to be related to electrolyte imbalance, an EKG can be repeated after correction of electrolytes
QTc > 450ms, history of Qtc prolongation or predisposition for QTc prolongation or family history of sudden cardiac death or QT prolongation
Must not have a family history of long QTc syndrome
Personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy.
Corrected QT interval using Fridericia’s formula (QTcF) value > 480 msec at screening; family or personal history of long corrected QT (QTc) syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG)
QTc greater than 480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or know history of QTc prolongation, or Torsade de Pointes (TdP).
Corrected QT interval using Fridericia's formula (QTcF) value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG)
QTcF > 480 msec, family or personal history of long QTc syndrome or ventricular bigeminy; previous history of drug-induced QTc prolongation or the need for medications known or suspected of producing prolonged QTc intervals on ECG
Family history of long QTc syndrome
Family history of long QTc syndrome
Consistent corrected QT (QTc) > 450 msec for men and > 470 msec for women by Fridericia formula, on 3 separate electrocardiograms (ECGs); patients with a history of long QTc syndrome or personal or family history of ventricular arrhythmias will be excluded
Corrected QT interval (QTc) using Fridericia's formula value > 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG).
Patient has a QTcF value of >480 msec; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation
QTc prolongation defined as a QTc greater than or equal to 470 ms or a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities