Prolongation of QTc interval to greater than msec
Subjects showing an average QTc interval over consecutive electrocardiograms (ECG) > msec in males and > msec in females at screening (? msec for subjects with bundle branch block (BBB) are not eligible.
Baseline QTc exceeding msec (using the Bazett's formula) and/or patients receiving class A or class III antiarrythmic agents.
Patients with QTc interval > msec.
Patients with QTc interval > msec for male and > msec for female.
ECG with correctd QT interval (QTc) > msec in males or > msec in females at screening
Electrocardiogram (ECG) abnormalities of Q-wave infarction, unless identified or more months prior to screening or QTc Fridericia (F) interval > msec
No QTc with Bazetts correction that is unmeasurable, or >= msec on screening electrocardiogram (ECG) obtained within days prior to registration for protocol therapy; if a subject has QTc >= msec on screening ECG, the screen ECG may be repeated twice (at least hours apart); the average QTc from the three screening ECGs must be < msec in order for the subject to be eligible for the study; NOTE: co-administration of drugs that in some reports might be associated with Torsades de Pointes but at this time lack substantial evidence of Torsades de Pointes should be avoided within weeks of randomization and during study; however, these drugs will be allowed, at the discretion of the investigator, if considered\r\nabsolutely necessary; in such cases, the subject must be closely monitored including regular checks of QTc and electrolytes; for patients who start on the drugs in this group while on the study treatment, the ECG must be checked within hours of commencing the concomitant medication and then at least once per week while the patient remains on the medication; the frequency of ECG monitoring could revert to the standard schedule if no QTc prolongation has been noted during weeks of co-administration of a drug; the electrolytes should be maintained within the normal range using supplements if necessary
STRATUM A: Participants with QTc interval of > msec on screening electrocardiogram (ECG)
STRATUM B: Participants with QTc interval of > msec on screening ECG
STRATUM C: Participants with QTc interval of > msec on screening ECG
Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to > msec for males or > msec for females, based on ECG at screening (patients with stable atrial fibrillation on treatment are allowed provided they do not meet any other cardiac or prohibited drug exclusion criterion);
Patients with QTc interval > msec or those known to have congenital long QTc syndrome.
Baseline QTc exceeding msec (msec for females) and / or patients receiving class A or class III anti-arrhythmic agents.
QTc interval of ? msec (males) or msec (females) calculated according to Fridericia's formula (QTc = QT/RR.; RR=RR interval)
A QTc interval outside of normal. (Normal: < msec for males and < msec for females)
Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ? msec for men and msec for women, or LVEF ? % by MUGA or ECHO).
Baseline electrocardiogram demonstrating all of the following: corrected QT (QTc) < milliseconds (msec) (men) and < msec (women), PR < msec, QRS < msec
QTc prolongation > msec or other significant ECG abnormality noted within days of treatment
Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ? msec for men and msec for women), or LVEF ? % by MUGA or ECHO.
History of serious ventricular arrhythmia (VT or VF, ? beats in a row), QTc ? msec for men and msec for women, or LVEF ? % by MUGA or ECHO.
Patients with QTc > msec.
QTc interval > msec
Screening ECG QTc interval msec for females, msec for males.
Screening ECG QTc interval msec for females, msec for males.
Screening corrected QT (QTc) interval >= msec for males or >= msec for females; PR interval > msec for males and females within weeks prior to start of any therapy
On ECG a QTc(F) interval > msec or any clinically significant cardiac rhythm abnormalities.
Baseline electrocardiogram (ECG) QTc > msec.
QTc interval > msec (males) or > msec (females); or repeated demonstration of a QTc interval > msec.
Patients with mean QTc interval > msec at screening and patients taking drugs known to prolong the QTc interval (see Section , Appendix D) who cannot be switched to an alternative drug
Subjects with baseline QTc interval > msec at screening
QTc > msec (including subjects on medication);
Patients with baseline QTc > msec.
QTc > msec
Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > msec) using the Fridericia method of correction for heart rate.
Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > msec) using the Fridericia method of correction for heart rate
Electrocardiogram (ECG) showing clinically significant abnormality at Screening or showing an average QTc interval ? msec in males and ? msec in females (? msec for subjects with Bundle Branch Block (BBB) over consecutive ECGs).
Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than msec in adults and msec in pediatrics (< years).
Corrected QT (QTc) interval > msec; if QTc interval is > msec, then additional electrocardiograms (ECGs) should be obtained over a brief period of time (e.g., within - minutes) to confirm the abnormality; the average QTc interval will be determined from the ECG tracings by manual evaluation and will be used to determine if the subject will be excluded from the study; the same method of QTc determination must be used throughout the subjects participation in the trial
Parts A, B, C, and E: Have QTc interval of > millisecond (msec) on screening electrocardiogram (ECG). Part D participants have QTc interval of >msec on screening ECG. Additional Exclusion Criteria For Part C
QTc < msec on screening ECG.
QTc interval ? msec at Baseline
Screening ECG QTc interval ? msec for females, ? msec for males.
Patients must have QTc interval less than msec
Mean resting QTc > msec obtained from ECGs
Subjects with a QTc > msec (QTc > msec for subjects with Bundle Branch Block) at baseline
Patients with QTc prolongation (defined as a QTc interval equal to or greater than msec) or other significant echocardiogram (ECG) abnormalities are excluded
QTc > msec
QTc > msec on electrocardiogram
Mean QTc >= msec (for males) or QTc >= msec (for females)
QTc interval >. seconds
Appropriately corrected screening ECG QTc interval msec for females, msec for males.
Clinically relevant findings in the ECG such as a second-degree or third-degree atrioventricular (AV) block (subjects with AV block and pacemaker in place for > year and checked by a cardiologist within ? months before the first dose of study drug will not be excluded), prolongation of the QRS complex over msec or of the QTc interval (Fridericia, QTcF) over msec (subjects with a pacemaker and QRS interval over msec or QTc inverval over msec may be enrolled on a case-by-case basis, following a discussion between the investigator and the sponsor).
Screening ECG with a QTc > msec.
Patients must have an electrocardiogram (EKG) documenting normal intervals (especially QTc interval < msec) and no arrhythmia prior to enrollment
Mean QTc interval >= msec at screening
Baseline QTc exceeding msec ( msec for females) using the Bazetts formula and/or patients receiving class A or class III antiarrythmic agents.
QTc interval <= msec
Screening ECG QTc interval ? msec for females, ? msec for males.
Subjects with a QT interval corrected for heart rate according to Bazett's formula (QTcB) <millisecond (msec) or <msec for subjects with bundle branch block. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
Electrocardiogram (EKG) abnormalities of:\r\n* Q-wave infarction, unless identified or more months prior to screening\r\n* QTc interval > msec, the upper limit of normal for women
Grade > QTc prolongation at baseline (> msec by Bazett formula) confirmed by a repeat electrocardiogram (ECG)
QTc greater than msec.
Have a QTc interval greater than msec
QTc with Fridericias correction that is not measurable, or >= msec on screening electrocardiogram (ECG); (Note: if a patient has a QTc interval >= msec on screening ECG, the screen ECG may be repeated twice [at least hours apart]; the average QTc from the three screening ECGs must be < msec in order for the patient to be eligible for the study); patients who are receiving a drug that has a risk of QTc prolongation are excluded if QTc is >= msec
Have QTc interval of > msec on screening electrocardiogram
Subject has electrocardiogram (ECG) showing clinically significant abnormality at screening or an average QTc interval (Fridercia's or Bazett's formula) > msec in males and > msec in females (> msec for subjects with Bundle Branch Block (BBB)).
Has an -lead ECG obtained at screening visit which shows medically significant abnormality(ies) (e.g. left bundle branch block, frequent premature ventricular contractions, QTc interval prolongation > msec for males and > msec for females)
Screening ECG with a QTc > msec. If QTc > and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc.
QTc with Fridericia's correction that is unmeasurable, or ? msec on screening ECG. The average QTc from the screening ECG (completed in triplicate) must be < msec in order for the patient to be eligible for the study;
Has QTc (QT interval corrected for rate) prolongation defined as: a) Symptomatic QTc prolongation > msec (males) or > msec (females) OR b) Any QTc prolongation of > msec
QTc with Bazetts correction that is unmeasurable or >= msec on screening electrocardiogram (ECG); (Note: if a subject has a QTc interval >= msec on screening ECG, the screen ECG may be repeated twice [at least hours apart]; the average QTc from the three screening ECGs must be < msec in order for the subject to be eligible for the study)
QTc interval < millisecond (msec).
QTc prolongation > msec.