The subject has a baseline corrected QT interval =< 480 ms
Patients with a prolonged corrected QT interval (QTc) interval (>= 450 ms)
Baseline corrected QT (QTc) < 480 ms
Baseline corrected QT (QTc) =< 500 ms
Adequate cardiac conductivity with corrected QT interval (QTC) of < 450 ms on screening electrocardiogram (ECG)
A baseline corrected QT interval of > 500 ms; patients with left bundle branch block that is deemed not clinically significant may be enrolled with corrected QT > 500
Congenital long QT syndrome or a corrected QTc interval ? 470 ms at screening
Mean resting corrected QT (QTc) interval using the Fridericia formula (QTcF) > 450 ms (i.e., grade 1 or higher) for males and > 470 ms for females on electrocardiogram (ECG) prior to initiation of study treatment obtained from 3 electrocardiograms (ECGs) obtained 2-5 minutes apart at study entry, or history of congential long QT syndrome\r\n* If baseline QTc on screening ECG is > 450 ms for males or > 470 ms for females:\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm QTcF interval\r\n* For patients with baseline heart rate (HR) < 60 bpm or > 100 bpm, manual measurement of QT interval by cardiologist is required, with Fridericia correction applied to that manual measurement to determine the QTc for eligibility consideration\r\n* Note: For patients with HR 60-100 bpm, manual measurement of QTc interval is NOT required
Corrected QT (QTc) interval < 480 ms (as calculated by the Fridericia correction formula)
Long QT or prolonged QTc (>460 ms)
History of long QT syndrome or whose corrected QT(QTc) interval measured (Fridericia method) at screening is prolonged (>450 ms)
Corrected QT interval at screening greater than (>) 480 milliseconds (ms) (average of triplicate screening measurements)
Subject has QT interval corrected (QTc) >480 ms (both males and females) at Screening (repeat values may be obtained during the period between Screening and admission to the study site).
Corrected QT interval (QTc) prolongation (defined as a QTc >450 ms for males and >470 ms for females [Fridericia's correction]) or other clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator
Have normal QT interval on electrocardiogram (ECG) evaluation QT corrected of =< 450 ms in males or =< 470 ms in females obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine-derived corrected QT (QTc) value
Within two weeks prior to enrollment: Corrected QT (QTc) interval =< 450 ms
QT corrected by Bazzett's formula (QTcB) must be < 470 milliseconds (ms) for males and < 480 ms for females
Screening 12-lead ECG with a measurable QTc interval according to Fridericia's correction >450 ms.
Patients with a corrected QT (QTc) > 480 ms in the baseline electrocardiography (EKG)
Has a QT interval corrected for heart rate (QTc) > 470 ms using the Fridericia formula; if the screening electrocardiogram (ECG) has a QTc > 470ms, the mean QTc of 3 electrocardiograms (ECGs) can be utilized, but must be < 470 ms
Corrected QT (QTc) (Fridericia Correction Formula) > 480 ms on electrocardiogram (ECG)
QT interval corrected for heart (QTc) >= 470 ms calculated from 1 electrocardiogram (ECG) using Fridericia's correction
Prolongation of QT/ corrected QT (QTc) interval (QTc interval > 450 ms for males or > 470 ms for females) using the Fridericia method of QTc analysis.
Corrected QT (QTc) > 500ms at baseline (average of 3 determinations at 10 minute intervals)
12?lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula >450 ms in males or >470 ms in females at screening or history of long QT interval corrected syndrome.
Corrected QT interval ([QTc] Fridericia) > 480 ms
Patients, who continue to have prolonged corrected QT (QTc) (males: > 450 ms; females: > 470 ms as calculated by Fridericia’s correction formula) despite normal electrolyte balance and discontinuation of medications known to prolong QTc, will be excluded from the study
Clinically active cardiac disease, including prolonged corrected QT (QTc) interval >= 481 ms (i.e. >= grade 2)
Patients with baseline corrected QT (QTc) > 470 ms or patients with symptomatic bradycardia
Congenital QT syndrome, corrected QT (QTc) > 500 ms
Corrected QT (QTc) =< 480 ms
Corrected QT interval (QTc) > 500 ms at baseline
Corrected QT (QTc) interval =< 480 ms by electrocardiogram (EKG)
Has a corrected QT prolongation to > 450 millisecond (ms) in males and > 470 ms in females
Patients must have an electrocardiogram (EKG) within 28 days prior to registration according to the following parameters:\r\n* Male patients must have a corrected QT (QTc) =< 450 ms\r\n* Female patients must have a QTc =< 470 ms
QTc interval < 450 ms
Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant.
QTcb >470 ms
Corrected QT (QTc) interval prolongation greater than 500 ms
To be performed within 28 days prior to day 1 of protocol therapy: Corrected QT (QTc) interval =< 480 ms (12 lead-electrocardiography [ECG])
Prolonged corrected QT interval (QTc) > 450 milliseconds (ms) at the screening visit
Patients with baseline corrected QT (QTc) > 450 ms or patients who are taking medications that prolong the QTc interval at the time of screening
The subject has a corrected QT interval (QTc) > 500 ms at screening or has a history of long QT syndrome
Within 30 days of registration: Corrected QT interval (QTc) must be < 450 ms in males and < 470 ms in females
Evidence of corrected QT (QTc) prolongation as defined as QTc using Fredericia's formula (QTcF) > 470 ms (per Fridericia’s formula)
Baseline corrected QT interval (QTc) =< 480 ms
Averaged corrected QT interval (QTc) baseline in 3 electrocardiography (ECG)s at least 5 minutes apart of >= 450 ms
Severe conduction abnormality including significant corrected QT (QTc) prolongation > 450 ms
Corrected QT interval (QTc) greater than 460 ms at baseline
Baseline corrected QT interval (QTc) < 480 ms
Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms).
Congenital long QT syndrome or a corrected QTc interval ?450 ms at the Screening visit.
QTc interval of > 480 ms.
Corrected QT interval (QTc) > 500 ms at baseline (average of 3 determinations at 10 minutes interval)
Patients with a baseline electrocardiography (ECG) demonstrating a corrected QT (QTc) > 460 ms
History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 470 ms). Individuals who screen fail due to this criterion are not eligible to be re-screened
Corrected QT interval (QTc) =< 500 milliseconds (ms)
Prolongation of QTc interval to greater than 480 ms
Mean QT interval ?470 ms
History of prolonged QT syndrome or electrocardiogram (ECG) at screening QT interval corrected for heart rate (QTc) of > 470 ms with Bazett’s or Fridericia’s formula
Baseline corrected QT interval (QTc) =< 480 milliseconds (ms)
Baseline screening corrected QT (QTc) < 470 ms is eligible
Corrected QT interval (QTc) =< 480 ms within 14 days before enrollment
Baseline corrected QT interval (QTc) =< 480 ms
QRS interval ? 110ms
PR interval ? 200ms
Corrected QT (QTc) interval > 450 ms for men or 470 ms for women, or known history of QTc prolongation or Torsades de Pointes
A baseline corrected QT interval of > 470 ms
Electrocardiogram (ECG) corrected QT (QTC) interval < 470 ms
Patients must have a corrected QT (QTc) interval < 450 ms on baseline electrocardiogram (EKG)
Patient must not have corrected QT (QTc) > 500 ms within 14 days before enrollment
Patients with a baseline corrected QT interval (QTc) > 500 ms
Corrected QT (QTc) interval =< 470 ms on screening electrocardiogram (ECG)
Mean corrected QT (QTc) > 450 ms at time of screening
Baseline corrected QT interval (QTc) =< 480 ms
ECG: QTc interval ? 450 ms
Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction formula).
Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
Corrected QT interval (QTc) < 470 ms
Corrected QT interval (QTc) greater than 450 ms
Corrected QT (QTc) interval >= 450 ms (ie, grade 1 or higher) on electrocardiogram (ECG) prior to initiation of study treatment\r\n* If baseline QTc on screening ECG is >= 450 ms (ie, grade 1 or higher):\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm QTc interval\r\n* For patients with baseline heart rate (HR) < 60 beats per minute (bpm) or > 100 bpm, manual measurement of QT interval by cardiologist is required, with Fridericia correction applied to that manual measurement to determine the QTc for eligibility consideration\r\n* Note: For patients with HR 60-100 bpm, manual measurement of QTc interval and use of Fridericia calculation is NOT required
History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 480 ms for males and females).
Corrected QT (QTc) interval =< 480 ms
Corrected QT (QTc) interval =< 480 ms
Pre-treatment corrected QT (QTc) interval of greater than 490 ms
11. Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction formula).
Corrected QT interval (QTc) < 470 ms
Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
The subject has a corrected QT interval (QTc) > 480 ms at screening or has a history of long QT syndrome
History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). Individuals who screen-fail due to this criterion are not eligible to be re-screened
Corrected QT interval (QTc) of > 450 milliseconds (ms) in males and > 470 milliseconds (ms) in females on baseline electrocardiogram (ECG) (using Fridericia [QTcF] corrected QT interval
Corrected QT (QTc) interval =< 480 ms
Patients should not be allergic to eggs or soy beans. Patients must be medically, psychologically and neurologically stable and have triplicate baseline ECG's with a mean QTc interval <500 ms and >300 ms and neither a history of congenital prolonged or short QT syndrome. Patients with a history of cardiac disease must be stable.
QTc interval prolongation >450ms for males and >470 ms for females.
A baseline ECG QTc > 470 ms
Baseline corrected QT interval (QTc) > 450 ms
Prolonged QTc interval (males >450ms, females >470ms)
Prolonged QTc interval (males >450ms, females >470ms)
Corrected (Bazett) QTc interval of > .50 ms (male) or > .52 ms (female)
Correct QT (QTc) longer than 500 ms
Corrected QT (QTc) =< 450 ms
Prolongation of corrected QT interval of > 480 ms
Corrected QT (QTc) interval =< 480 ms
PATIENTS: History of prolonged corrected QT (QTc) interval (> 500 ms)
Patients with corrected QT (QTc) interval greater than 450 ms
Patients must not have baseline corrected QT (QTc) interval >= 500 ms
Previously documented and persistent corrected QT (QTc) prolongation (> 500 ms)
Patient must have an electrocardiogram without evidence of arrhythmia, QT prolongation (corrected QT [QTc] > 450 ms in males and > 470 ms in females), or other severe dysfunction within 2 weeks of registration
Patients with familial short QT syndrome or with corrected QT (QTc) interval =< 300 ms
Corrected QT interval (QTc) > 450 ms per Fridericia’s correction
Corrected QT (QTc) (Fredericia’s formula) < 470 ms
Evidence of corrected QT (QTc) prolongation on pre-treatment electrocardiography (ECG) (greater than 440 ms in males or greater than 460 ms in females)
Evidence of corrected QT (QTc) prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 460 ms in females)
Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 450 ms in females)
Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
Subjects with QTc interval > 480ms.
Congenital long QT syndrome or a corrected QTc interval of ?450 ms at the Screening visit.
QTc > 450 ms (M) or 470 ms (F) (Bazett formula -QT Interval / ? (RR interval) where RR Interval = 60/HR).
Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:\r\n* Resting corrected QT interval (QTc) =< 480 msec\r\n** NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs\r\n* The following only need to be assessed if the mean QTc > 480 msec\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc\r\n** For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required\r\n** For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc\r\n** Patient must not have hypokalemia (value < institutional lower limit of normal)\r\n* No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, 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** NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs
Prolongation of QTc interval to greater than 480 msec
Subjects showing an average QTc interval over 3 consecutive electrocardiograms (ECG) >450 msec in males and >470 msec in females at screening (? 480 msec for subjects with bundle branch block (BBB) are not eligible.
Baseline QTc exceeding 450 msec (using the Bazett's formula) and/or patients receiving class 1A or class III antiarrythmic agents.
Patients with QTc interval > 450 msec.
Patients with QTc interval >450 msec for male and >470 msec for female.
Subjects with baseline QT prolongation > 470 msec
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): QTc interval =< 450 msec for men or =< 470 msec for women within 2 weeks of registration
ECG with correctd QT interval (QTc) >450 msec in males or >470 msec in females at screening
No QTc with Bazett’s correction that is unmeasurable, or >= 480 msec on screening electrocardiogram (ECG) obtained within 7 days prior to registration for protocol therapy; if a subject has QTc >= 480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart); the average QTc from the three screening ECGs must be < 480 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 2 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 24 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 4 weeks of co-administration of a drug; the electrolytes should be maintained within the normal range using supplements if necessary
STRATUM B: Participants with QTc interval of > 450 msec on screening ECG
STRATUM C: Participants with QTc interval of > 450 msec on screening ECG
Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to >480 msec for males or >500 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 > 480 msec or those known to have congenital long QTc syndrome.
Baseline QTc exceeding 450msec (470msec for females) and / or patients receiving class 1A or class III anti-arrhythmic agents.
QTc interval of ? 450 msec (males) or 470 msec (females) calculated according to Fridericia's formula (QTc = QT/RR0.33; RR=RR interval)
A QTc interval outside of normal. (Normal: < 450 msec for males and < 460 msec for females)
Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ? 450 msec for men and 470 msec for women, or LVEF ? 40% by MUGA or ECHO).
Baseline electrocardiogram demonstrating all of the following: corrected QT (QTc) < 450 milliseconds (msec) (men) and < 470 msec (women), PR < 240 msec, QRS < 100 msec
QTc prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment
Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ? 450 msec for men and 470 msec for women), or LVEF ? 40% by MUGA or ECHO.
History of serious ventricular arrhythmia (VT or VF, ? 3 beats in a row), QTc ? 450 msec for men and 470 msec for women, or LVEF ? 40% by MUGA or ECHO.
History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females.
Patients with QTc > 480 msec.
QTc interval > 450 msec
Screening ECG QTc interval 470 msec for females, 450 msec for males.
Screening ECG QTc interval 470 msec for females, 450 msec for males.
Screening corrected QT (QTc) interval >= 450 msec for males or >= 470 msec for females; PR interval > 250 msec for males and females within 4 weeks prior to start of any therapy
On ECG a QTc(F) interval >480 msec or any clinically significant cardiac rhythm abnormalities.
QT intervals of QTc ? 500 msec
Baseline QTc > 470 msec or previous history of QT prolongation while taking other medications
QTc interval >460 msec (males) or >470 msec (females); or repeated demonstration of a QTc interval >450 msec.
Patients with mean QTc interval >450 msec at screening and patients taking drugs known to prolong the QTc interval (see Section 9, Appendix D) who cannot be switched to an alternative drug
Subjects with baseline QTc interval >470 msec at screening
QTc > 470 msec (including subjects on medication);
Screening 12-lead ECG with measurable QTc interval (according to either Fridericia's or Bazett's correction) of >=470 msec).
Patients with baseline QTc > 480 msec.
QTc >480 msec
Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > 470 msec) using the Fridericia method of correction for heart rate.
Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > 470 msec) using the Fridericia method of correction for heart rate
Electrocardiogram (ECG) showing clinically significant abnormality at Screening or showing an average QTc interval ?450 msec in males and ?470 msec in females (?480 msec for subjects with Bundle Branch Block (BBB) over 3 consecutive ECGs).
Parts A, B, C, and E: Have QTc interval of > 470 millisecond (msec) on screening electrocardiogram (ECG). Part D participants have QTc interval of >450msec on screening ECG. Additional Exclusion Criteria For Part C
QTc <450 msec on screening ECG.
QTc interval ? 470 msec at Baseline
Patients taking drugs that can cause significant QTc/QTf prolongation unless able to be switched to non-QTc/QTf prolonging medication or on a stable dose without significant QT prolongation (> 470 msec)
Screening ECG QTc interval ?470 msec for females, ?450 msec for males.
Patients must have QTc interval less than 450 msec
Normal corrected QT (QTc) interval defined on electrocardiogram (EKG) as QTc =< 440 msec\r\n* Note: patients who are assigned to arm B must have QTc =< 440 msec on day (D)1 and D8 of cycle 1 of eribulin treatments for continued eligibility\r\nPostmenopausal women defined as women with:\r\n* Prior bilateral surgical oophorectomy, or\r\n* Medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause
Mean resting QTc >470 msec obtained from 3 ECGs
Subjects with a QTc > 480 msec (QTc > 510 msec for subjects with Bundle Branch Block) at baseline
Patients with QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant echocardiogram (ECG) abnormalities are excluded
QTc > 450 msec
QTc > 470 msec on electrocardiogram
Mean QTc >= 450 msec (for males) or QTc >= 470 msec (for females)
Appropriately corrected screening ECG QTc interval 470 msec for females, 450 msec for males.
Currently receiving medications known to cause QT prolongation AND corrected QTc of 450 msec for females, 430 msec for males.
QT/QTc interval > 450 msec, as determined by screening ECG performed no earlier than 1 week before C1D1
Screening ECG with a QTc > 450 msec.
Baseline QTc >470 msec and/or previous history of QT prolongation while taking other medications.
Baseline ATc>470 msec and/or previous history of QT prolongation.
Mean QTc interval >= 480 msec at screening
Baseline QTc exceeding 450 msec (470 msec for females) using the Bazetts formula and/or patients receiving class 1A or class III antiarrythmic agents.
QTc interval <= 300 msec
Screening ECG QTc interval ? 470 msec for females, ? 450 msec for males.
Baseline QTc > 470 msec or previous history of QT prolongation while taking other medications
Grade > 1 QTc prolongation at baseline (> 450 msec by Bazett formula) confirmed by a repeat electrocardiogram (ECG)
QTc greater than 470 msec.
Have a QTc interval greater than 470 msec
QTc with Fridericia’s correction that is not measurable, or >= 480 msec on screening electrocardiogram (ECG); (Note: if a patient has a QTc interval >= 480 msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]; the average QTc from the three screening ECGs must be < 480 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 >= 460 msec
Baseline QTc ?470 msec and no previous history of QT prolongation while taking other medications.
Subject has electrocardiogram (ECG) showing clinically significant abnormality at screening or an average QTc interval (Fridercia's or Bazett's formula) >450 msec in males and >470 msec in females (>480 msec for subjects with Bundle Branch Block (BBB)).
Has an 12-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 > 450 msec for males and > 470 msec for females)
Screening ECG with a QTc > 450 msec. If QTc > 450 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 ? 480 msec on screening ECG. The average QTc from the screening ECG (completed in triplicate) must be < 480 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 >450 msec (males) or >470 msec (females) OR b) Any QTc prolongation of >500 msec
QTc with Bazett’s correction that is unmeasurable or >= 450 msec on screening electrocardiogram (ECG); (Note: if a subject has a QTc interval >= 450 msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]; the average QTc from the three screening ECGs must be < 450 msec in order for the subject to be eligible for the study)
QTc interval <480 millisecond (msec).
QTc prolongation >480 msec.
Patients with QTc interval > 470 milliseconds
Patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Corrected QT (QTc) interval =< 480 milliseconds
Corrected QT (QTc) interval =< 480 milliseconds
Marked baseline prolongation of QT/corrected QT (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Corrected QT interval (QTc) of < 480 milliseconds
Prolongation of QT corrected (QTc) interval to >480 milliseconds (ms)
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 500 ms)
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/ corrected QT (QTc) ([QT interval/corrected QT interval], eg, a repeated demonstration of a QTc interval > 500 ms)
Baseline QTc prolongation (e.g., repeated demonstration of QTc interval > 480 milliseconds or history of congenital long QT syndrome or torsades de pointes)
History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful. Screening corrected QT (QTc) interval > 470 msec is excluded (corrected by Fridericia). If a single QTc is > 470 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 470 milliseconds. For subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the JTc interval may be used in place of the QTc with sponsor approval. The JTc must be < 340 milliseconds if JTc is used in place of the QTc. Subjects with left bundle branch block are excluded. Note: QTc prolongation due to pacemaker may enroll if the JTc is normal or with medical monitor approval.
Baseline corrected QT (QTc) interval >= 480 milliseconds
No previous history of corrected QT (QTc) prolongation as a result of medication that required discontinuation of that medication
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful; screening corrected QT (QTc) interval > 470 milliseconds is excluded; in the event that a single QTc is > 470 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 470 milliseconds; for subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the corrected JT (JTc) interval may be used in place of the QTc with sponsor approval; the JTc must be < 340 milliseconds if JTc is used in place of the QTc; subjects with left bundle branch block are excluded\r\n* Note: QTc prolongation due to pacemaker may enroll if the JTc is normal
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful; screening corrected QT (QTc) interval >= 480 milliseconds is excluded; in the event that a single QTc is >= 480 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 480 milliseconds; for subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the corrected JT (JTc) interval may be used in place of the QTc with the approval of the principal investigator; the JTc must be < 340 milliseconds if JTc is used in place of the QTc; subjects with left bundle branch block are excluded; note: QTc prolongation due to pacemaker may enroll if the JTc is normal
Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds or history of congenital long QT syndrome or Torsades de pointes
Concomitant use of a drug with a known risk of corrected QT interval (QTc) prolongation
Known QT interval prolongation
Prolongation of corrected QT (QTc) interval to >480 milliseconds (msec) when electrolyte balance is normal
Corrected QT (QTc) interval > 0.450 seconds (males) or > 0.470 seconds (females), or known history of QTc prolongation or Torsade de Pointes (TdP)
Marked baseline prolongation of QT/corrected QT interval (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval > 480 millisecond [ms], or history of congenital long QT syndrome, or torsades de pointes).
Marked baseline prolongation of QT/corrected QT (QTc) interval (QTc interval >= 500 msec) using the Fridericia method (QTc = QT/RR0.33) for QTc analysis
Corrected QT (QTc) interval > 480 ms (>= grade 2) on a 12-lead electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG is >= grade 2:\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to QTc\r\n* For patients with heart rate < 60 beats per minute (bpm) or > 100 bpm, manual read of the QT interval by a cardiologist is required, with Fridericia correction applied to determine Fridericia QTc (QTcF) which must be used to determine eligibility\r\n* Note: If heart rate is 60-100 bpm, manual read of the QT interval and correction to QTcF is not required
Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant (such as acute ischemia, left bundle branch block, ventricular arrhythmias) or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds)
Baseline prolongation of the rate-corrected QT interval (QTc) (e.g. repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsades de pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females); valvular, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure
Screening corrected QT interval (QTc) interval > 470 milliseconds
Marked baseline prolongation of QT/corrected QC (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Corrected QT interval (QTc) prolongation > 450 milliseconds (msec)
Prolongation of QTc interval to >480 milliseconds (ms)
Prolongation of QT interval (QT)/corrected QT interval (QTc) (QTc interval > 470 ms) using the Fridericia method of QTc analysis
Corrected QT (QTc) interval =< 480 milliseconds
Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of =< 470 milliseconds (ms)
Corrected QT (QTc) interval > 450 ms on screening 12-lead electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG meets exclusion criteria:\r\n** Check calcium, potassium, and magnesium serum levels\r\n** Correct any identified hypocalcemia, hypokalemia, and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to prolonged QTc interval\r\n* For patients with heart rate (HR) 60-100 beats per minute (bpm), manual read of QTc is not required\r\n* For patients with a baseline HR < 60 bpm or > 100 bpm, manual read of the QT interval by a cardiologist is required, with Fridericia correction applied to determine QTc (ie, QTcF)
Marked baseline prolongation of QT/QT corrected (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Corrected QT interval (QTc) > 480 milliseconds as corrected by the Fridericia formula
QTc interval >0.450 seconds (males) or >0.470 (females), or known history of QTc prolongation or Torsade de Pointes (TdP)
A clinically significant electrocardiogram (ECG) abnormality, including a marked Baseline prolonged QT/QTc interval (e.g., a repeated demonstration of a QTc interval >500 milliseconds (msec)).
History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds).
Corrected QT interval duration prolongation
No marked baseline prolongation of QT/QTc interval
Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval >480 millisecond [ms], or history of congenital, long-QT syndrome, or torsades de pointes).
Have a corrected QT interval >470 milliseconds as calculated be the Fredericia equation.
A clinically significant electrocardiogram (ECG) abnormality (ie, corrected QT interval [QTc] interval greater than 480 msec when electrolyte balance is normal), or a history of risk factors for torsade de pointes, hypokalemia, long QT syndrome, or the use of concomitant medications resulting in a prolongation of QTc interval.
Known history or predisposition to QT interval prolongation
Prolongation of QT/QTc interval
Treatment with medications known to cause corrected QT (QTc) interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/corrected QT (QTc) ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 480 ms), a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes (TdP)
Concurrent use of digoxin due to cardiac disease; corrected QT (QTc) interval >= 450 milliseconds in men and >= 470 milliseconds in women within 2 weeks of registration or known history of QTc prolongation or Torsades de Pointes
Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds).
Corrected QT interval (QTc)/QT Fridericia equation (QTf) interval >= 480 milliseconds; unless secondary to pacemaker or bundle branch block
The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB)
Participant has a corrected QT (QTc) interval > 470 ms or known history of QTc prolongation or Torsade de Pointes
Corrected QT (QTc) prolongation, as defined by > 470 milliseconds on ECG
Prolongation of corrected QT interval (QTc) > 480 milliseconds using Bazett’s formula
Corrected QT interval (QTc) > 475 milliseconds
The subject has a baseline corrected QT interval < 500 within 28 days before randomization
Treatment with medications known to cause corrected QT (QTc) interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms)
Clinically significant abnormality on electrocardiogram (ECG). The corrected QT interval (QTc, Fridericia) must be < 470 milliseconds for men and < 490 milliseconds for women (Must be confirmed by at least 2 additional 12-lead ECGs at least 2 minutes apart such that average manually over-read QTcF based on 3 ECGs exceeds stated thresholds)
QTc interval >0.45 seconds
Patients must not have QTc prolongation defined as a QTc interval equal to or greater than 450 milliseconds (msecs)
Concurrent administration of crizotinib and agents that can cause corrected QT (QTc) prolongation is not permitted
Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
Corrected QT interval (QTc) > 470 msec on electrocardiogram (by Bazett’s; average of triplicate recordings at the discretion of the principal investigator [PI]) will exclude patients from entry on study; medications that are known to cause QTc interval prolongation are prohibited for patients entering on trial; patients for whom a given medication that may cause QTc interval prolongation cannot be discontinued, may be eligible at the discretion of the study PI, provided QTc interval criteria is met at enrollment
Has marked prolongation of QTc interval at screening or baseline using the Fridericia method of correction for heart rate
Clinically significant electrocardiogram (ECG) abnormality, including a marked Baseline prolonged QT interval/corrected QT interval ([QT/QTc], example, a repeated demonstration of a QTc interval >500 millisecond [ms]).
Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes
Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of MK-2206 treatment and medication not listed as causing torsades de pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec*; long QT syndrome; the required use of concomitant medication that may cause torsades de pointes or may cause a significant prolongation of the QTc\r\n*Note: Due to difficulties assessing QTc in patients with heart block, they may be eligible if deemed safe by a cardiologist
Must not have QT interval of >470 millisecond.
Corrected QT (QTc) interval >= 500 milliseconds
Concomitant medication that may cause Torsade de Pointes, i.e. prolongation of the QT interval > 500 msec
History of familial long QT syndrome, or use of medications that may cause QTc interval prolongation
Corrected QT (QTc) prolongation with other medications; if the medication can be discontinued and an alternative medication started that does not cause QTc prolongation, the patient would be eligible; if no alternative medication is available and the medication cannot be discontinued for medical reasons, then the patient would not be eligible
Prolongation of corrected QT interval (QTc) > 480 milliseconds (msec)
Patients must not have a marked baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration of a QTc interval > 500 milliseconds (ms)
Corrected QT interval (QTc) > 470 milliseconds on baseline electrocardiogram (ECG) (using corrected QT interval using Fridericia [QTcF] or Bazett [QTcB]); if electrolytes are abnormal, they may be corrected and baseline ECG should be repeated
Patients may not currently be taking quinidine, ceritinib, highest risk corrected QT interval (QTc)-prolonging agents, mifepristone, or succinylcholine
Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 500 ms)
EXCLUSION CRITERIA FOR CROSSOVER THERAPY: Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval], e.g., a repeated demonstration of a QTc interval > 500 ms)
Current evidence of cardiac arrhythmias defined as corrected QD interval (QTc) >= 480 mm/sec
Patients with a known pathologic prolongation of the corrected QT (QTc)
Corrected QT (QTc) interval within normal range for age
Marked baseline prolongation of QT/corrected QT (QTc) interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
Previous history of Corrected QT Interval (QTc ) prolongation resulting from medication that required discontinuation of that medication
Patients with corrected QT (QTc) interval > 0.47 seconds
Patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) are ineligible
Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of romidepsin treatment and medication not listed as causing Torsades de Pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec*; long QT syndrome; the required use of concomitant medication that may cause Torsades de Pointes or may cause a significant prolongation of the QTc\r\n* Note: due to difficulties assessing QTc in patients with heart block, they may be eligible if deemed safe by a cardiologist; if a patient must take ondansetron as their antiemetic, their QTc may NOT be over 450 (no exception for patients with heart block)
Corrected QT (QTc) prolongation with other medications that required discontinuation of that medication
Prolongation of corrected QT interval (QTc) to >480 ms as demonstrated by a repeated electrocardiogram (ECG) or a clinically significant ECG abnormality, including a marked prolonged QT/QTc interval (eg, a repeated demonstration of a QTc interval >500 ms).
Patient with Frederica's (QTcF) formulas (QTcF) ?450 msec;
Males with mean QTcF values of > 450 msec and females with QTcF values of > 470 msec following 3 ECGs conducted 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes; or patients who are on medications known to cause prolonged QT intervals on ECG;
Corrected QT interval by Fredericia (QTcF) > 500 msec within 1 month before the first dose of study treatment:\r\n* Three electrocardiograms (ECGs) must be performed for eligibility determination. If the average of these three consecutive results for QTcF is =< 500 msec, the subject meets eligibility in this regard
QTcF > 460 msec on Screening electrocardiogram (ECG)
Participant has a QTcF interval > 450 msec (average of triplicate determinations) by central read.
Medical history of uncontrolled but clinically significant abnormal cardiac conduction abnormalities at electrocardiogram (ECG), any history or evidence of long QT syndrome or QTcF interval >450 msec for males and ?470 msec for females (according to Fridericia's correction) at screening
QTcF <500 msec
Fridericia's correction formula (QTcF) > 500 msec within 1 month before the first dose of study treatment:\r\n* Three electrocardiography (ECG)s must be performed for eligibility determination; if the average of these three consecutive results for QTcF is =< 500 msec, the subject meets eligibility in this regard
Evidence of currently uncontrolled cardiovascular conditions as listed in the protocol; acute myocardial infarction with 6 months before starting study drug; baseline QT interval (QTcF) greater than (>) 450 milliseconds (msec) (males) or > 475 msec (females); or abnormalities on baseline 12-lead electrocardiogram (ECG) that are considered clinically significant per investigator.
Patients with mean QTcF values of > 470 msec (in females) or > 450 msec (in males) following 3 ECGs conducted 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes; or patients who are on medications known to cause prolonged QT intervals on ECG.
QTcF >450 milliseconds (msec) or QTcF >480 msec for subjects with bundle branch block
Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) > 500 millisecond (msec)
QT interval adjusted according to Fredericia (QTcF) > 480 msec on screening electrocardiogram (ECG)
Significant abnormalities on ECG at screening. QTcF >450 msec for males or >470 msec for females at screening
Subjects with a QTcF interval of >470 msec; if the Screening ECG QTcF interval is >470 msec, it may be repeated, and if repeat <470 msec, the subject may be enrolled.
QTcF interval < 450 msec and mean resting heart rate 50-90 bpm
A baseline ECG QTcF > 470 msec
QTcF > 470 msec on the screening ECG
12 lead ECG with QtcF interval ? 470 msec
Screening QTcF >450 msec or current medication known to prolong QT
QTcF prolongation (defined as a QTcF > 450 msec)
QTcF >450 msec (males) or >470 msec (females).
On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.
At Screening QTcF ?450 msec for males and ?470 msec for females.
QTcF > 480 msec
Screening electrocardiogram (ECG) with a QTcF > 450 millisecond (msec)
QTcB ? 480 msec
QTcF >500 msec (males or females)
Mean QTcF ?450 msec (for males) or ?470 msec (for females) at Screening
Baseline mean QTcF ? 450 msec (for males) or ? 470 msec (for females) at Screening.
Predose mean QTc? 450 msec or QTcF ? 450 msec.
Mean QTcF interval > 450 msec at screening.
QTcF > 470 msec on the screening ECG
Subject with a QTcF of > 450 msec in male subjects and > 470 msec in female subjects on the screening 12 lead ECG.
Patients with baseline QTcF ? 480 msec
QTcF ? 450 msec for males or 470 msec for females.
Screening and Baseline QTcF (Fridericia's) less than 470 msec
Patient has clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
QTcF interval on electrocardiogram (ECG) at screening > 450 msec for males or > 460 for females;
The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes.
Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTcF-interval over 450 msec
Cardiovascular baseline corrected QT by Fridericia's (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study
QTcF interval > 450 msec (males) or > 470 msec (females)
Pretreatment QTcF interval >470 msec (females) or >450 msec (males)
A baseline ECG QTcF > 470 msec
At Screening, QTcF >450 msec for males; QTcF >470 msec for females
QTcF interval < 450 msec and mean resting heart rate 50-90 bpm
Friderichia corrected QT interval (QTcF) >450 milliseconds (msec) (men) or >475 msec (women) on a 12-lead electrocardiogram (ECG) during the Screening period.
Prolongation of QTcF interval to >480 milliseconds (msec)
Subject has QTcF interval > 450 msec (average of triplicate determinations based on central reading).
Patients must have corrected QT (QTc) interval < 500/msec (by Bazett’s formula) on baseline ECG
Corrected QT interval (QTc) < 480 msec
Patients with a baseline QTc of > 450 msec are excluded; Bazett’s formula is to be used for measurement of the corrected QT interval: the QT interval (msec) divided by the square root of the RR interval (msec)
Corrected QT interval, QTc < 480 msec\r\n* Note: Repeat echocardiogram is not required if echocardiogram was obtained within 21 days of study enrollment
Baseline corrected QT interval (QTc) =< 450 msec\r\n* Note: QT interval calculation by the Fridericia formula is permitted
Corrected QT interval (QTc) < 480 msec
Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead electrocardiography (ECG) during screening
Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to >450 msec for males or >470 msec for females.
Corrected QT interval (QTc) interval greater than 450 msec (males) or greater than 470 msec (females).
Patients must have a corrected QT (QTc) interval of less than 480 msec
Patients must not have a corrected QT interval (QTc) of > 480 msec using Bazett’s formula
Corrected QT (QTc) interval > 470 msec
Corrected QT (QTc) interval < 470 msec
Participants must have a corrected QT (QTc) of =< 470 msec on the screening electrocardiography (EKG)
Corrected QT (QTc) interval > 500 msec, unless a bundle branch block is also present
Corrected QT interval (QTc) =< 480 msec
Consistent corrected QT (QTc) > 450 msec for men and > 470 msec for women by Fridericia formula, on 3 separate electrocardiograms (ECGs)
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Corrected QT (QTc) interval =< 450 msec for men or =< 470 msec for women within 2 weeks of registration
Patients with corrected QT (QTc) interval of > 450 msec or those on medications known to prolong QTc interval
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE grade >= 2 or prolongation of the corrected QT interval (QTc) interval to > 500 msec
Participants with any history of corrected QT (QTc) prolongation (i.e. QTc interval of > 450 msec)
Mean QT interval ? 470 msec
COHORT 3: ENDOMETRIAL CANCER: Patients with a mean corrected QT (QTc) interval of > 500 msec or receiving therapeutic agents known to prolong the QT interval
Corrected QT (QTc) < 500 msec by Fridericia
Corrected QT interval (QTc) prolongation > 480 msec
Subjects with a corrected QT (QTc) > 480 ms (QTc > 510 msec for subjects with a bundle branch block at baseline
Screening rate-corrected QT interval (QTc) must be <450msec and a resting heart rate of at least 50-90 bpm via a standard 12-lead ECG within 28 days prior to registration.
Subjects with a corrected QT (QTc) > 480 ms (QTc > 510 msec for subjects with a bundle branch block at baseline)
Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening
Mean resting corrected QT interval (QTc) >470 msec
PART 2 GROUP 1 INCLUSION CRITERIA: Corrected QTc =< 480 msec
PART 2 GROUP 2A INCLUSION CRITERIA: Corrected QTc =< 480 msec
PART 2 GROUP 3 INCLUSION CRITERIA: Corrected QTc =< 480 msec
Corrected QT (QTc) =< 450 msec. for men or QTc =< 470 msec. for women
Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
Corrected QT interval (QTc) =< 480 msec
Screening electrocardiography (ECG) with corrected QT (QTc) interval > 480 milliseconds (corrected by Fridericia); in the event that a single QTc is > 480 msec, the subject may enroll if the average QTc for 3 ECGs is < 480 msec
Patients with prolonged corrected QT interval, defined as corrected QT (QTc) > 450 msec
Corrected QT (QTc) interval >= 480 msec (>= 500 msec for subjects with bundle branch block)
Nilotinib\r\n* Normal QTc interval on screening ECG evaluation, defined as < 450 msec for men and < 470 msec for women\r\n* Discontinuation of any medications known to contribute significantly to the risk of QT prolongation at least 48 hours prior to start of study drug; Levaquin and Zofran are an exception; of note, certain agents that prolong the corrected QT interval may be allowed but only after discussion with the chemotherapy pharmacist; should the investigator believe that therapy with a potentially QT prolonging medication is vital to an individual subject’s care, then additional ECGs should be done at the investigator’s discretion to ensure the subject’s safety
Syndrome of congenital corrected QT interval (QTc) prolongation or QTc > 500 msec
Mean resting corrected QT interval (QTc) >450 millisecond (msec), obtained from 3 ECGs recordings, using the screening clinic ECG machine-derived QTc value.
QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening
QT interval corrected for rate (QTc) > 480 msec for on the ECG obtained at Screening using Fridericia method for QTc calculation
Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, or prolongation of the corrected QT interval defined as > 450 msec for males and > 470 msec for female
Corrected QT (QTc) interval =< 450 msec
Patients with prolonged corrected QT(QTc) interval defined as male > 450 msec and female > 470 msec
Corrected QT (QTc) interval > 470 msec (females) or > 450 msec (males)
Corrected QT interval (QTc) =< 470 msec (based on average of screening triplicates)
Subjects must have normal corrected QT interval (QTc) =< 470 msec (based on average of screening triplicates)
Baseline corrected QT (QTc) interval > 500 msec
Corrected QT interval (QTc) =< 480 msec per Fridericia’s formula AND PR interval =< 200 msec (using 12-lead electrocardiography [EKG])
Corrected QT interval (QTc) =< 480 msec
Patients with corrected QT interval (QTc) prolongation greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 (> 480 msec); in addition, patients should not be receiving non-study medications known to prolong QTc
Corrected QT interval (QTc) =< 480 msec
Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening
Has QT interval corrected for heart rate (QTc) ?480 msec.
Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec in adults and 450 msec in pediatrics (< 18 years).
Mean resting corrected QT interval (QTc) ?450 msec for males and ?470 msec for females.
Patients must have corrected QT (QTc) =< 500 msec
Corrected QT interval (QTc) < 480 msec
Corrected QT (QTc) interval > 500 msec; if QTc interval is > 500 msec, then 2 additional electrocardiograms (ECGs) should be obtained over a brief period of time (e.g., within 15-20 minutes) to confirm the abnormality; the average QTc interval will be determined from the 3 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 subject’s participation in the trial
QT interval corrected (QTc) <450 millisecond (msec) or QTc <480 msec for patients with bundle branch block.
Mean resting correct QT interval (QTc) >470 msec obtained from triplicate electrocardiagrams
Grade 3 corrected QT interval (QTc) prolongation (QTc > 500 msec on two separate electrocardiograms (ECGs)
Subjects with a corrected QT interval (QTc) > 480 msec (QTc > 510 msec for subjects with bundle branch block) at baseline
Corrected QT interval (QTc) of > 480 msec using Bazett’s formula
No ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of corrected QT (QTc) interval to > 480 msec
Corrected QT (QTc) interval > 500 msec, unless a bundle branch block is also present
Patient with corrected QT (QTc) interval must be less than 500 msec
Patients must have corrected QT (QTc) < 500 msec
Corrected QTc > 470 msec; the corrected QTc may be corrected using either Bazett’s or Fridericia’s formula; in general Fridericia corrected QT interval (QTcf) is the preferred correction method
Corrected QT (QTc) interval > 470 msec
Corrected QT interval (QTc) (based on Bazett) > 450 msec on baseline ECG; if QTc > 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
Bazett-corrected QT (QTcB) interval ?501 msec at the time of transition to this study
Corrected QT (QTc) interval >/= 480 msec at the time of transition to this study
Corrected QT interval (QTc) must be < 500 msec
Subjects with a corrected QT interval (QTc) <450 milliseconds (msec) or <480msec for subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine or manual overread. For subject eligibility and withdrawal, QTcF will be used. For purposes of data analysis, QTcF will be used. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period
Participants with mean corrected QTc interval > 500 msec, as assessed within 4 weeks prior to enrollment, or participants who require medication known to prolong the QT interval
Corrected QT (QTc) (Frederica) prolongation > 470 msec
Corrected QT (QTc) interval =< 470 msec
Corrected QT interval (QTc) > 480 msec
Patients with a baseline QT/corrected QT (QTc) interval >= 501 msec
QTc (corrected QT) interval < 480 msec.
Corrected QT (QTc) interval > 450 msec (males) or > 470 msec (females)
Subjects with a QT interval corrected for heart rate according to Bazett's formula (QTcB) <450millisecond (msec) or <480msec 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.
Corrected QT interval (QTc) of greater than 500 msec
Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec.
Patient must have a QT/QTc interval ? 450 msec.
Corrected QT (QTc) interval > 500 msec
Corrected QT interval (QTc) ? 450 msec at least 7 days prior to registration for protocol therapy.
Patients with marked baseline prolongation of QT/corrected QT (QTc) interval (QTc interval > 450 msec for males or > 470 msec for females) using the Fridericia method for QTc analysis
Corrected QT interval (QTc) =< 480 msec
Patients with a known or screening-period-determined corrected QT (QTc) interval > 450 msec and patients who require a therapy with a drug known to prolong the QT/QTc interval, are ineligible
Corrected QT interval (QTc) =< 480 msec
Cardiovascular risk, including:\r\n* Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110\r\n* Congestive heart failure\r\n* Myocardial infarction within the past year\r\n* QT prolongation, defined as pretreatment corrected QT interval (QTc) > 440 msec in males or > 460 msec in females