Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from electrocardiograms (ECGs) using Fridericia’s correction; abnormal ECGs should be repeated
Symptomatic arrhythmia. If QTc greater than or equal to 470ms, confirmation of eligible QTc requires mean calculation from 2 additional electrocardiograms (ECGs) 2?5 minutes apart using Fridericia's Correction Formula (mean less than 470 ms).
Subject has a mean QT interval corrected for heart rate using Bazett's (QTcB) or Fridericia's (QTcF) correction ? 500 ms calculated from 3 consecutive 12-lead ECGs at Screening;
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
Has a mean QT interval corrected for heart rate (QTc) ? 470ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s Correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms using Fridericia’s correction.
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction.
QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms; (any clinically significant abnormalities detected require triplicate electrocardiogram [ECG] results and a mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms calculated from 3 ECGs)
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from electrocardiograms (ECGs) using Bazett’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms. Any clinically significant abnormalities detected, require triplicate electrocardiogram (ECG) results and a mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms calculated from 3 ECGs.
Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart)
Known mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction. (Note that ECG is not required for study entry and is not part of study procedures)
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from a baseline electrocardiogram using Fridericia’s correction
A single QT interval corrected for heart rate (QTc) >= 470 ms. If an electrocardiogram (ECG) is interpreted to be a prolonged QT interval, 2 additional ECGs will be obtained and the PI will then evaluate all three ECGs and determine whether the patient should be excluded. Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s correction
Mean QT interval corrected for heart rate (corrected QT interval [QTc]) >= 470 ms calculated from electrocardiogram (in triplicate, if applicable) using Fridericia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction.
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
Mean QT interval corrected for heart rate (QTcF) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia’s correction
Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from an electrocardiograms (ECGs) using Bazett’s Correction; if first ECG is abnormal, then the mean will be calculated from 3 consecutive ECGs (taken 2-5 minutes apart); please contact the PI for further clarification
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Bazett’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 2 electrocardiograms (ECGs) using Bazett’s correction; two electrocardiogram (EKGs) 5 minutes (+/- 2 min) apart is mandatory
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 consecutive electrocardiograms (EKGs) using Fridericia’s correction at baseline or before dosing
Prolonged QTc greater than or equal to 470 ms. If QTc greater than or equal to 470ms, confirmation of eligible QTc requires mean calculation from 2 additional electrocardiograms (ECGs) 2?5 minutes apart using Fridericia's Correction Formula (mean less than 470 ms).
Mean corrected QT interval (QTc) > 450 ms for males or > 470 msec for females calculated from 3 electrocardiograms (ECGs) using Fridericia's formula (within at least 15 minutes, at least 5 minutes apart)
Mean QT interval corrected for heart rate (QTc) >/= 470 ms calculated from 3 electrocardiogram (ECGs) using Fredericia’s Correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from electrocardiogram (ECG) using Fridericia’s correction by manual read.
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiography (ECG)s using Frediricia’s correction
Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Bazett’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Bazett's formula
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
Mean QT interval corrected for heart rate (corrected QT [QTc]) < 470 msec calculated from 3 electrocardiograms (ECGs) performed at least 2 minutes apart using Fridericia’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Frederica’s Correction
Mean QT interval corrected for heart rate (QTc) ?470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
Mean QT interval corrected for heart rate (QTc) ?470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from a single electrocardiogram or average from 3 electrocardiograms (ECGs) using Fridericia's correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs)
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Frederica’s correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s correction
QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 70 ms; any clinically significant abnormalities detected, require triplicate electrocardiography (ECG) results and a mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms calculated from 3 ECGs
Mean QT interval corrected for heart rate (QTc) < 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
Corrected QT (by Bazett's formula [QTcB]) interval < 450 msec
QT interval corrected through use of Fridericia's formula (QTcF) > 470 milliseconds
Fridericiaís corrected QT interval (QTcF) >/= 480
Baseline Fridericia's correction formula (QTcF) < grade 2
12-lead Electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ? 470 msec Fridericia Formula.
Prolongation of corrected QT [QTcF (Fridericia's corrected QT interval)] interval to greater than 480 msec when electrolytes balance is normal
QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 msec or <480 milliseconds (msec) for subjects with bundle branch block.
QT interval corrected using Fridericia formula (QTcF) > 500 msec on average of screening electrocardiograms (EKGs) performed within 28 days of first dose of cabozantinib; three EKGs must be performed at screening; if the average of these three consecutive results for QTcF is > 500 msec, the subject is ineligible
Patients with a QT interval > 480 msec (using the Bazett's formula) within 28 days prior to registration are not eligible
Have a heart-rate corrected QT interval using Fridericia's method (QTcF) >470 msec.
Has electrocardiogram with a QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 msec or ECG with second degree type 2 or third degree atrioventricular block.
On screening, any of the following cardiac parameters: interval between P and R (PR interval) >220 milliseconds (msec), interval between Q, R, and S (QRS) interval >109 msec, or QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec;
Cardiac Function: Fridericia's correction formula (QTcF) < 480 milliseconds (Fridericia correction), and ejection fraction (EF) >= 50%
Participant has a Fridericia-corrected QT interval (QTcF) > 450 msec (average of triplicate determinations) per central read.
Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic ECG machine and Fridericia's formula for QT interval correction.
Corrected QT interval (QTc) < 470 msec (as calculated by the Fridericia correction formula [QTcF]).
Mean resting corrected QT interval (QTcF) >470 msec obtained from 3 ECGs
Fridericia's corrected QT interval (QTcF) =< 450 msec
QTc interval calculated according to Fridericia's formula (QTcF = QT/RR0.33; RR = RR interval) of ? 450 msec on screening electrocardiogram (ECG).
Corrected QT (QTc) interval (using Fridericia’s correction formula, QTcF, if prolonged) > 470 msec
Patients must have a baseline electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) within the normal range within 28 days prior to registration
12-lead Electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ? 470 msec
Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec.
Mean resting corrected QT interval (QTc) calculated using Fridericia's formula (QTcF) of >450 msec for males and >470 msec for females obtained from 3 electrocardiograms (ECGs) taken over 5 minutes
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients with a mean Fridericia's correction formula (QTcF) interval of > 500 msec or receiving therapeutic agents known to prolong the QT interval
QT interval corrected for heart rate using Fridericia's formula (QTcF) =< 500 msec
A corrected QT interval calculated by the Fridericia formula (QTcF) > 500 milliseconds within 28 days before first dose of study treatment. Three electrocardiograms (ECGs) must be performed for eligibility determination. If the average of these three consecutive results for QTcF is =< 500 milliseconds, the subject will be eligible.
Fridericia's corrected QT (QTcF) interval > 500 msec\r\nNote: 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
Have a Fridericia's QT corrected interval (QTcF) interval of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG) utilizing Fridericia's correction.
Baseline prolongation of the QT interval corrected for heart reate (HR) using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula (QTcF); example, repeated demonstration of QTcF interval >480 millisecond (ms), history of congenital long QT syndrome, or torsades de pointes).
Corrected QT using Fridericia's formula (QTcF) prolongation.
Corrected QT using Fridericia's formula (QTcF) > 500 msec within 1 month before the first dose of study treatment:\r\n* Three electrocardiogram (ECG)s must be performed for eligibility determination; if the average of these three\r\nconsecutive results for QTcF is =< 500 msec, the subject meets eligibility in this regard
Any of the following cardiac criteria: Mean resting corrected QTc interval using the Fridericia formula (QTcF) greater than 450 msec/male and greater than 470 msec/female or congenital long QT syndrome
Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 500 milliseconds (msec). Participants who have a pacemaker may be included regardless of calculated QTc interval
Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening electrocardiogram (EKG) > 480 msec
Corrected QT interval calculated by the Bazett formula (QTcB) > 480 msec
QTcF interval at screening <450 msec (using Fridericia's correction)
A corrected QT interval (QTc) ? 480 msec using the Fridericia's formula (QTcF)
Fridericia's corrected QT interval (QTcF) > 470 msec using the Fredericia formula
Corrected QT Interval Fridericia (QTcF) > 450 msec (both genders)
Fridericia's correction formula (QTcF) > 480 msec (males and females)
QTcF (Fridericia formula for the QT interval correction for the heart rate) > 480 msec within 4 weeks of enrollment; if the initial QTcF is found to be > 480 msec, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 480 msec, the subject meets eligibility in this regard; subjects with history of congenital long QT syndrome, or torsades de pointes, are not allowed
Has a QT interval corrected by Fridericia's formula (QTcF) ?480 msec
Pre-treatment Fridericia's correction formula (QTcF) > 480 msecs
Baseline QTc >470 msec measured by Fridericia's formula (QTcF) and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
QT interval corrected using Fridericia’s method (QTcF) < 460 msec
Mean resting corrected QTc interval using the Fridericia formula (QTcF) > 450 msec/male and > 470 msec/female (as calculated per institutional standards) obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long QT syndrome
Corrected QT interval using Fridericia's formula (QTcF) interval of > 450 msec at study entry; congenital long QT syndrome
Corrected QT interval by Fridericia's 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
Baseline QT Fridericia's correction formula (QTcF) ? 470 msec
Corrected QT interval (QTc) prolongation > 480 msec, as calculated by either the Bazett or Fridericia formula, as per institutional standard
A QT interval corrected for heart rate using the Fridericia’s formula (QTcF) >= 470 msec on screening exam
Fridericia's correction formula (QTcF) > 470 msec on screening electrocardiography (ECG) or congenital long QT syndrome
Patient has a QT interval adjusted by the Fridericia formula (QTcF) > 480 msec on screening electrocardiogram (ECG).
QT interval corrected using Fridericia's formula (QTcF) >470 msec or history of prolonged QT syndrome or Torsades de pointes, or familial history of prolonged QT syndrome.
Corrected QC interval calculated using Fridericia's formula (QTcF) =< 500 msec; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
Has a QT interval corrected by Fridericia's formula (QTcF) =< 450 msec
Patients with a mean QT interval corrected by Bazett's formula (QTcB) > 450 msec in males and > 470 msec in females
At screening QT interval corrected by Fridericia's formula (QTcF) >= 450 msec
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's\n             method (QTCF) greater than 450 msec
Corrected QT using the Fridericia formula (QTcF) < 470 msec
Subject has a corrected QT by the Fridericia formula (QTcF) > 480 msec on the screening electrocardiogram (ECG) (using the QTcF formula)
QT interval adjusted according to Fridericia (QTcF) > 480 msec on screening electrocardiography (ECG)
QT interval corrected by Fridericia's formula (QTcF) > 450 msec on screening electrocardiogram (ECG)
QT interval corrected for Fridericia formula (QTcF) at screening > 470 msec
Has a QT interval corrected by Fridericia's formula (QTcF) ?450 msec
Mean resting corrected QT interval (QTc using Fridericia’s formula [QTcF]) > 470 msec
Has a QT interval corrected by Fridericia's formula (QTcF) ?480 msec
Has a QT interval corrected by Fridericia's formula (QTcF) less than or equal to (<=) 480 milliseconds (msec)
Has a QT interval corrected by Fridericia's formula (QTcF) ?480 msec
Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ?450 milliseconds (msec) in males or ?470 msec in females.
Corrected QT interval > 480 msec (using the Fridericia formula)
QTcF interval at screening < 450 msec (using Fridericia's correction).
Corrected QT using Fridericia's correction formula (QTcF) =< 480 msec
The calculated Fridericia's corrected QT interval (QTcF) average of the triplicate electrocardiograms (ECGs) must be < 470 msec
The participant has a QT interval calculated using Bazett's formula (QTcB) interval of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG).
Mean resting corrected QT interval (Fridericia formula for QT interval correction [QTcF]) > 480 msec obtained from 3 electrocardiograms (ECGs)
QTcF interval at screening >450 msec (using Fridericia's correction)
Fridericia's formula (QTcF), or another method, machine or manual overread.
Patients with a corrected QT using Fridericia's formula (QTcF) or corrected QT using Bazett's formula (QTcB) > 480 ms in the baseline electrocardiogram (EKG)
Baseline Bazett's correction formula (QTcB) >= 470 msec
Screening electrocardiogram (ECG) with a corrected QT interval using Fridericia's formula (QTcFredericia)(QTcF) > 450 msec
Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of LOXO-195 or prolongation of the QT interval corrected (QTcF) > 480 msec within the past 6 months
A QT interval corrected for heart rate using Bazett's formula QTcB >= 480 msec
Subjects have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
Patients with a corrected QT interval using Fridericia's formula (QTcF) interval of > 450 msec on screening electrocardiogram (ECG); Note: if > 450 msec on the first ECG, 2 additional ECGs can be ordered same day and then the average may be used to determine eligibility
Mean resting corrected QT interval (QTc using Fridericia’s formula [QTcF]) > 470 msec
Have Fridericia-corrected QT interval (QTcF) >480 milliseconds on screening electrocardiogram (ECG).
Congenital long QT syndrome or QT interval corrected using Fridericia's formula (QTcF) >470 milliseconds (msec)
Corrected QT interval using Fridericia's formula (QTcF) interval equal to or less than 470 msec
Patients who have, at screening, corrected QT interval using Fridericia's formula (QTcF) >= 450 msec for males and QTcF >= 470 for females
A QT interval corrected for heart rate using the Bazett's formula (QTcB) >=480 millisecond (msec);
QT interval measurement corrected by Fridericia's formula (QTcF) interval of >450 msec (males) or >470 msec (females)
A corrected QT interval >=480 msec (e.g. Bazett's formula [QTcB])
Current long QT syndrome or baseline prolongation of QT/QTcF interval, i.e. demonstration of a QTcF interval > 450 msec
Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the Electrocardiogram (ECG) > 470 msec.
Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) <470 milli seconds (msec) or <480 msec with bundle branch block.
Normal ejection fraction (echocardiogram [ECHO] or cardiac MRI) >= 53% (or the institutional normal; if a range is given then the upper value of the range will be used); corrected QT (QTC) or Fridericia's correction formula (QTcF) =< 450 msec
Corrected QT (QTc) interval > 500 msec (Bazett formula or Fridericia formula based on institutional standard)
QT interval corrected for heart rate according to Fridericia's formula (QTcF) <450 milliseconds (msec) or QTcF <480 msec for subjects with bundle branch block.
Fridericia's Heart Rate Correction Formula (QTcF) interval >450 msec;
QT interval corrected using Fridericia's formula (QTcF) >450 milliseconds
Fridericia's correction formula (QTcF) =< 470 msec
Patients with a QT interval corrected by Fridericia's formula (QTcF) > 450 msec (QTcF > 480 msec for patients with bundle branch block)
Prolongation of the corrected QT interval by Fridericia's formula (QTcF) interval defined as > 450 msec for males and > 470 msec for females
Corrected QT (QTc) prolongation > 480 msec, as calculated by either the Bazett or Fridericia formula, as per institutional standard
QTc > 450 msec on the average of three serial baseline ECG (using the QTcF formula). If QTcF > 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-tested for QTc.This exclusion criterion is not applicable for patients with non-measurable QT interval who have evidence of measurable QT interval at the time of CML diagnosis (e.g. prior to first start of TKI treatment) and who have no documented clinical signs of cardiovascular disease and/or clinical signs of conduction abnormality.
Fridericia corrected QT interval (QTcF) >450 milliseconds (msec) (men) or >475 msec (women) on a 12-lead electrocardiogram (ECG) during the Screening period.
Patients with a corrected QT interval (QTc) > 480 msecs are NOT eligible for participation
Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
Corrected QT (QTc) interval =< 450 msecs
Corrected QT (QTc) interval =/< 470 msecs, no familial history of QTc prolongation or ventricular arrhythmias
Corrected QT interval (QTc) > 480 msecs
Baseline cardiac QTc interval > 450 msecs
Corrected QT interval (QTc) > 480 msecs using Bazett‘s formula
Corrected QT interval (QTc) > 480 msecs using Bazett's formula
Corrected QT (QTC) by 12 lead electrocardiography (EKG) < 450 msecs
Corrected QT (using Bazett's formula [QTcB]) interval < 500 msecs
Corrected QT interval (QTc) > 480 miliseconds (msecs)
Cardiac function: baseline corrected QT (QTc) interval =< 450 msecs
Baseline cardiac QTc interval > 450 msecs
Corrected QT interval (QTc) > 480 msecs using Bazett's formula; electrocardiography (EKG) for screening must be =< 28 days before registration
Patients must not have a corrected QT (QTc) interval >= 480 msecs within 28 days prior to registration
QTc\t=< 480 msecs
Corrected QT interval (QTc) > 480 msecs\r\n* Note: correction method should be reported
Corrected QT (QTc) interval greater than or equal to 480 msecs (>= 500 msec for subjects with bundle branch block)
Corrected QT interval (QTc) < 480 msecs
Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
QTcF interval greater than 500 msecs at the time of transition to this study.
Prolongation of corrected QT interval (QTc) > 480 msecs
Subjects with a baseline corrected QT (QTc) of equal to or greater than 480 msecs or other significant electrocardiogram (ECG) abnormalities
Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
Prolongation of corrected QT interval (QTc) > 480 msecs
Prolongation of corrected QT interval (QTc) > 480 msecs
EXPANSION COHORT ONLY: Prolongation of corrected QT interval (QTc) > 480 msecs
Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
Corrected QT interval (QTc) > 480 msecs using Bazett's formula.
Corrected QT (QTc) interval using Bazett's Formula; (QTcB) >= 480 msecs
Corrected QT interval > 480 msecs using Bazett's formula.
QTc interval greater than or equal to 480msecs.
Corrected QT interval (QTc) > 480 msecs
Corrected QT interval (QTc) > 480 msecs (record QTc correction method)
Patient must not have corrected QT interval (QTc) > 480 msecs using Bazett’s formula
Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration
Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.
Baseline corrected Fridericia QT (QTcF) >= 450 ms (males) or >= 470 ms (females)
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) for males and > 470 ms for females based on triplicate ECG.
Prolonged Fridericia's corrected QT (QTcF) > 450 ms for men and > 470 ms for women at screening.
Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms Part 2 Only:
The participant has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (ECGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the participant meets eligibility in this regard
QTc Fridericia (QTcF) >450 ms
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from an electrocardiogram (ECG) using Fridericia’s Correction (QTcF)\r\n* At screening, a single ECG will be obtained on which QTcF must be < 470 ms; in case of clinically significant ECG abnormalities, including a QTcF value > 470 ms, 2 additional 12-lead ECGs should be obtained over a brief period (eg, 30 minutes) to confirm the finding
Subjects must have a 12-lead electrocardiogram (EKG) showing no active ischemia and Fridericia's corrected QT interval (QTcF) less than 480 ms.
Prolongation of corrected QT using Fridericia's formula (QTcF) interval to > 480 ms
Corrected QT interval (QTc) > 500 ms, uncorrectable by managing electrolytes and medications, using the Fridericia's correction (QTcF) formula
Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 7 days before starting study treatment\r\n* Note: if the QTcF is > 500 ms in first electrocardiography (ECG), a total of 3 ECGs should be performed; if the average of these 3 consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) >= 470 ms; abnormality must be confirmed on 3 electrocardiography (ECG)s
Has a mean QTcF prolongation >470 ms for females and >450 ms for males in three successive Screening measurements.
Has history or presence of an abnormal electrocardiogram (ECG) which, in the investigator's opinion, is clinically significant\r\n* Corrected QT Fredericia's formula (QTcF) >= 480 ms or presence of a left bundle branch block (LBBB); if the QRS duration > 120ms, the JTc can be used in place of the QTcF; the JTc must be < 340 ms
Have normal QT interval on electrocardiogram (ECG) evaluation QT corrected Fridericia (QTcF) of =< 450 ms in males or =< 470 ms in females
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (EKG)s separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Baseline corrected QT interval (corrected QT interval by Fridericia's formula [QTcF]) < 480 ms
Subjects with prolongation of corrected QT interval by Fridericia’s method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) for males and > 470 ms for females based on triplicate electrocardiogram (ECG)
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before treatment; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Have normal QT interval corrected (Frederica) (QTcF) interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of ? 450 ms in males or ? 470 ms in females.
Fridericia corrected QT (QTcF) correction unmeasurable or > 450 ms on screening ECG (Note: If a patient has a QTcF interval > 450 ms on screening ECG, the screening ECG may be repeated twice [at least 24 hours apart] for a total of 3 ECGs; the average QTcF from the three screening ECGs must be =< 450 ms in order for the patient to be eligible for the study)
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is >450 ms for males or >470 ms for females based on triplicate electrocardiograms (ECGs).
A corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before first dose of study treatment; three electrocardiograms (ECGs) must be performed; if the average of these three consecutive results for QTcF is =< 500 msec, the subject meets eligibility in this regard
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Corrected QT interval using Fridericia's formula (QTcF) interval less than or equal to 480 ms (Phase II only)
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Corrected QT for Fridericia (QTcF) interval greater than 500 ms that is not correctable to less than 500 ms such as with cessation of a causative medication, etc
Baseline Fridericia corrected QT (QTcF) > 480 ms; NOTE: this criterion does not apply to patients with a left bundle branch block
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening QTcF interval >480 ms is excluded. In the event that a single QTcF is >480 ms, the subject may enroll if the average QTcF for the 3 ECGs is < 480ms. For patients with an intraventricular conduction delay (QRS interval >120ms), the JTc interval may be used in place of the QTcF with Sponsor approval. The JTc must be <340 ms if JTc is used in place of the QTcF. Patients with an intraventricular delay due to a left bundle branch block are excluded; Note: QTcF prolongation due to pacemaker may enroll if the JTc is normal.
QTcF interval >470 ms on screening ECG.
Baseline QT interval corrected with Fridericia's method (QTcF) >480 ms NOTE: this criterion does not apply to subjects with a right or left bundle branch block (BBB)
For screening electrocardiographs (ECGs), exclude patients with a Fridericia's corrected QT interval (QTcF) > 480 ms, or JTc > 340 ms for those with an intraventricular conduction delay. If the screening ECG has a QTcF > 480 ms, eligibility can be confirmed if the average of 3 ECGs done 5 minutes apart have an average QTcF < 480 ms
Corrected QT using Fridericia's formula (QTcF) =< 450 ms
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms =< 7 days before the first dose of study treatment
Cardiac ejection fraction >= 50%, and Fridericia's formula corrected QT (QTcF) < 450 ms (male) or < 470 ms (female) on electrocardiogram (ECG) at baseline
DOSE ESCALATION COHORT: History or presence of an abnormal electrocardiogram (ECG) which, in the investigator's opinion, is clinically meaningful; screening corrected QT using Fridericia’s formula (QTcF) interval > 480ms is excluded; subjects with left bundle branch block are excluded
Patients with clinically significant cardiovascular disease; this includes:\r\n* Myocardial infarction or unstable angina within 6 months prior to registration\r\n* New York heart association (NYHA) class II or greater congestive heart failure\r\n* History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate\r\n* Any history of congenital long QT syndrome\r\n* The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiogram (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Subjects who have a corrected QT (Fridericia's correction formula [QTcF]) interval > 480 milliseconds (ms) (CTCAE grade > 1) determined by the electrocardiogram (ECG) recorder’s algorithm on the screening ECG
A corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the patient meets eligibility in this regard
Subjects with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
For participants receiving alectinib: baseline Fridericias corrected QT interval (QTcF) greater than (>) 470 milliseconds (ms) or symptomatic bradycardia.
Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before start of treatment; Note: at baseline (i.e. screening), three ECGs to be obtained within 30 minutes but approximately 2 to 3 minutes apart (i.e. triplicate); if the average of the three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
QTcF values higher than 450 ms at screening
Subjects with mean QTcF interval > 500 ms.
Evidence of QTcF prolongation defined as > 450 ms for males and > 470 ms for females at screening
Fridericia´s Corrected QT interval (QTcF) prolongation > 450 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome). The QTcF will be calculated as the mean of the 3 ECGs taken at screening.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before treatment initiation
Subject with mean Fridericia-corrected QT interval (QTcF) > 450 ms at screening based on central reading.
A screening Fridericia corrected QT interval (QTcF) >= 450 ms (men) or >= 470 ms (women)
Corrected QT interval using Fridericia's formula (QTcF) > 470 msec within 4 weeks of enrollment; if the initial QTcF is found to be > 470 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 470 ms, the subject meets eligibility in this regard
A screening Fridericia corrected QT interval (QTcF) ? 450 ms (men) or ? 470 ms (women).
Baseline corrected QT interval using Fridericia's formula (QTcF) > 480 ms; NOTE: this criterion does not apply to patients with a left bundle branch block
Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ?450 ms in males or ?470 ms in females.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 milliseconds (ms) within 28 days before initiation of cabozantinib; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
QT interval corrected for heart rate by Fridericia's formula (QTcF) ? 480ms
Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms (average of triplicate readings) Note: This criterion does not apply to subjects with a right or left bundle branch block (BBB)
Subject has Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
Patient has a corrected QT interval (QTcF) > 500 ms at screening
Corrected QT interval corrected for Fridericia's formula (QTcF) < 450 ms
Corrected QT interval according to Fridericia (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before initiation of protocol therapy; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization
The patient has a corrected QT interval (corrected QT using Fridericia formula [QTcF]) > 500 ms within 28 days before randomization; if QTcF is >= 500 ms by Bazett formula, this must be confirmed by the Fridericia formula
Normal QT Fridericia-corrected interval (QTcF) ?450 ms for males and ?470 ms for females
QT-interval corrected according to Fridericia's formula (QTcF) ? 450 ms on electrocardiogram (ECG) at Screening
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) > 450 ms
Subject has QTcF interval > 450 ms on 12-lead ECG at screening.
Normal QT interval corrected (Fridericia) (QTcF) on screening electrocardiogram (ECG) evaluation, defined as QTcF of =< 450 ms in males or =< 470 ms in females
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before day 1 of cycle 1; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
Cardiovascular disorders including:\r\n* Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\r\n* The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard\r\n* Any history of congenital long QT syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Unstable angina pectoris\r\n** Clinically-significant cardiac arrhythmias\r\n** Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n** Myocardial infarction\r\n** Cardiomyopathy
Cardiac ejection fraction ?50%, and QTcF<450 ms (males) or <470 ms (females) on ECG at Baseline.
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) >450 ms
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 ms for males and > 470 ms for females based on triplicate electrocardiogram (ECG).
QTcF corrected with Frederica's or Bazett's formula QTcB >450 ms for males and >470 ms for females on screening ECG.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before enrollment; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 14 days before week 1 day 1
QTcF >450 ms for males and >470 ms for females on screening ECG
Fridericia's corrected QT (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome); the QTcF will be calculated as the mean of the 3 electrocardiograms (ECGs) taken at screening\r\n* NOTE: The formula used to calculate QTcF can be physician’s choice, but it must be used consistently throughout the study
Prolonged corrected interval between the Q wave and T wave (QTc) by Fridericia's correction factor (QTcF) interval on pre-entry ECG ?450 ms (average of 3 ECG readings done in triplicate);
Baseline Fridericia corrected QT (QTcF) > 480 ms; NOTE: this criterion does not apply to patients with a left bundle branch block
Subject has a QTcF > 480 ms (corrected) in the screening or baseline ECG.
A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation (Fridericia corrected QT interval [QTcF] > 500 ms), 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
A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation (QT interval by Fridericia's correction formula [QTcF] > 500 ms), 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
Has a mean corrected QT interval using Fridericia's Correction Formula (QTcF) prolongation to > 470 ms for females and > 450 ms for males in three successive Screening measurements
Has prolonged corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) based on triplicate electrocardiograms (ECGs)
Baseline Fridericia's correction formula (QTcF) or corrected QT (QTc) > 480 ms.; NOTE: This criterion does not apply to patients with a left bundle branch block
QTcF interval >450 ms for men and >470 ms for women, symptomatic bradycardia <45 beats per minute or other significant ECG abnormalities in the investigator's opinion.
On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); all as determined by screening ECG (mean of triplicate ECGs)
Standard 12-lead electrocardiography (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Fridericia's correction formula (QTcF) interval at screening < 450 msec (using Fridericia’ s correction)\r\n* Resting heart rate 50 to 100 beats per minute
Patients must have at screening a standard 12-lead electrocardiogram (ECG) with mean values that meet the following parameters:\r\n* Fridericia's correction QT (QtcF) interval at screening < 450 msec (using Fridericia’s correction)\r\n* Resting heart rate of 50-90 beats per minute (bpm)
On screening inability to determine the corrected QT using Fridericia's formula (QTcF) interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); all as determined by screening ECG (mean of triplicate ECGs)
Patient with standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Fridericia's correction formula (QTcF) interval at screening < 450 msec (using Fridericia’s correction)
QT interval with Fridericia's correction [QTcF] >470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
Screening electrocardiogram (ECG) (defined as the mean of the triplicate ECGs) with QTcF interval at screening =< 450 msec (using Fridericia’s correction) and resting heart rate >= 50 bpm
Meets the following standard 12-lead electrocardiography (ECG) parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Corrected QT using Fridericia's correction formula (QTcF) interval at screening < 450 msec for males and < 470 msec for females\r\n* Resting heart rate =< 100 beats per minute (bpm)
Patients with available standard 12-lead electrocardiography (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Fridericia's correction formula (QTcF) interval at screening < 450 msec\r\n* Resting heart rate 50-90 beats per minute (bpm)
Patient with available standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Corrected QT interval using Fridericia's formula (QTcF) at screening < 450 msec (using Fridericia’s correction)\r\n* Resting heart rate 50-90 bpm
Standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* QT corrected by Fridericia's formula (QTcF) interval at screening < 450msec (using Fridericia’s correction)
Fridericia's correction formula (QTcF) interval on standard 12-lead electrocardiography (ECG) parameters at screening (defined as the mean of the triplicate ECGs) of < 450 msec for males and < 470 msec for females
QTcF interval ?450 msec using the mean of triplicate electrocardiograms (ECGs).
On screening, inability to determine the Fridericia corrected QT interval (QTcF) interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); all as determined by screening ECG (mean of triplicate ECGs)
A QTc interval of >470 msec by the Fridericia formula (QTcF), at the Screening ECG. If the subject's QTcF is >470 msec on the initial ECG, a total of 3 ECGs should be obtained at least 3 minutes apart and all within 30 minutes. The average of the 3 QTcF's will be used to determine eligibility. Known or suspected causes of prolonged QTc can be treated (e.g., hypocalcemia, hypokalemia, hypomagnesimia) and the ECGs may be repeated. If the subject initiates treatment with a drug known to prolong the QTc during the Screening period after the initial Screening ECGs were obtained, the Screening ECGs must be repeated once the new drug has reached steady state to ensure the average QTcF remains ?470 msec. For subject's whose heart rate is <60 bpm, the Bazett correction formula (QTcB) may be used.
Inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); NOTE: all as determined by screening ECG
Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory.
QTcF > 460 msec on screening Electrocardiography (ECG) (mean of triplicate recordings).
Inability to determine the QTcF interval on the ECG (i.e. unreadable or not interpretable) or QTcF > 450 msec (using Fridericia's correction). All as determined by screening ECG (using the mean QTcF of triplicate ECGs)
On screening, inability to determine the Fridericia's corrected QT (QTcF) interval on the ECG (i.e.: unreadable or not interpretable) or QTcF> 450 msec (using Fridericia’s correction); all as determined by screening ECG
Patient with available standard 12-lead electrocardiography (ECG) with the following parameters at screening: a. Corrected QT interval by Fridericia's formula (QTcF) interval at screening < 450 msec (using Fridericia’s correction). b. Resting heart rate 50-100 beats per minute (bpm).
Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value.
QT (Interval from the beginning of the QRS complex to the end of the T wave on an electrocardiogram) interval with Fridericia's correction [QTcF] >450 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
QTcF greater than 460 msec on Screening ECG (mean of triplicate recordings)
QTcF > 470 msec on Screening ECG (mean of triplicate recordings).
Uncontrolled or severe cardiovascular disease, including myocardial infarction, unstable angina, or atrial fibrillation (AFib) within 6 months prior to study treatment, New York Heart Association (NYHA) class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, cardiac amyloidosis, or corrected QT (QTc) with Fridericia’s (QTcF) correction that is unmeasurable or >= 480 msec on screening electrocardiography (ECG); (Note: for QTcF >= 480 sec on the screening ECG, the ECG may be repeated twice at least 24 hours apart; the mean QTcF from the three screening ECGs must be < 480 msec in order to meet eligibility for trial participation)
History of congenital long QT syndrome or corrected QT interval (QTc) > 450 msec within 2 weeks of randomization
Participants may not have corrected QT (QTc) > 470 msec or family history of long QT syndrome
Congenital long QT syndrome or corrected QT interval (QTc) > 500 msec
Corrected QT interval (QTc) > 480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes
Must not have a family history of long corrected QT interval (QTc) syndrome
Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:\r\n* History of clinically significant (as determined by the treating physician) atrial arrhythmia; or any ventricular arrhythmia\r\n* History of congenital long QT syndrome\r\n* Abnormal QT corrected for heart rate using Bazett's formula (QTcB) (>= 450 msec in males and >= 470 msec in females)\r\n* Ejection fraction =< 50% as assessed by echocardiogram
Fridericia-corrected QT interval (QTcF) > 470 msec (female) or history of congenital long QT syndrome.
Fredericia-corrected QT interval (QTcF) >470 msec (female) or >450 msec (male), or history of congenital long QT syndrome.
Participant with mean resting corrected QT interval (specifically QTc calculated using the Fridericia formula [QTcF]) > 450 msec for males and > 470 msec for females, from 3 electrocardiograms (ECGs) performed within 2-5 minutes apart at study entry, or congenital long QT syndrome
History of congenital long QT syndrome or mean (average of triplicate measurements) corrected QT (QTc) measured using Fridericia's method >/=450 millisecond (ms) at baseline or uncorrectable abnormalities in serum electrolytes (sodium, potassium, calcium, magnesium, phosphorus) Vismodegib
Any known cardiac abnormalities such as:\r\n* Congenital long QT syndrome\r\n* Corrected QT(QTc) interval >= 500 milliseconds
Baseline Fridericia's corrected QT (QTcF) interval greater than 470 msec (female) or greater than 450 msec (male), history of congenital long QT syndrome, the presence in the screening electrocardiography (ECG) of a conduction abnormality that in the opinion of the investigator would preclude safe participation in this study
PHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: Prolongation of QT/corrected QT (QTc) interval (QTc interval > 500 msec) using the Fridericia method of QTc analysis or family history of long QT syndrome; if single reading is above these minimum ranges, then repeat test in triplicate and evaluate eligibility based on average value
mCRPC EXPANSION COHORT: Prolongation of QT/QTc interval (QTc interval > 500 msec) using the Fridericia method of QTc analysis or family history of long QT syndrome; if single reading is above these minimum ranges, then repeat test in triplicate and evaluate eligibility based on average value
Corrected QT interval (QTc) > 470 msec (as calculated per institutional standards) at study entry or congenital long QT syndrome
Corrected QT (QTc) interval > 480 msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes
Corrected QT (QTc) prolongation > 480 msec (Bazett's formula) or congenitally long QT syndrome
Corrected QT (QTc) interval (Fridericia formula) > 450 msec for men or > 470 msec for women at study entry; history of congenital long QT syndrome
Patients with resting corrected QT interval (specifically QTc calculated using the Fridericia formula [QTcF]) > 470 msec from a single electrocardiogram (ECG) performed at study entry or congenital long QT syndrome.
Corrected QT (QTc) interval > 480 msec (based on the mean value of the triplicate electrocardiography [ECG]s), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.
Any of the following cardiac criteria:\r\n* Mean resting corrected QT interval (QTc using Fridericia’s formula [QTcF]) > 470 msec obtained from 3 electrocardiograms \r\n* Congenital or family history of long or short QT syndrome, Brugada syndrome, known history of QTc prolongation or torsades de pointes within 12 months of entering the study\r\n* Abnormal echocardiogram at baseline (left ventricular ejection fraction [LVEF] < 40% and shortening fraction [SF] < 15%)
Prolonged QT interval (corrected QT interval [QTc] > 480 milliseconds) on screening electrocardiogram (EKG) or congenital long QT syndrome
Patients must not have a screening corrected QT Fridericia’s formula (QTcF) interval > 480 msec based on the average of the triplicate electrocardiograms (EKGs) performed within 28 days prior to registration; NOTE: triplicate EKGs are required at other timepoints; patients must not have any family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes
Patients must not have a screening QTcF interval > 480 msec based on the average of the triplicate EKGs performed within 28 days prior to step 2 re-registration; NOTE: triplicate EKGs are required at other timepoints; patients must not have any family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes
Patients with congenital long QT syndrome, bradyarrhythmias, or QTc > 480 msec are not eligible
At screening, patients must have no known history of congenital long QT syndrome and must have a corrected mean QTc interval =< 450 msec at baseline
Mean resting corrected QT interval (QTc) calculated using Fridericia's formula (QTcF) >450 msec obtained from 3 electrocardiograms (ECGs); family or personal history of long or short QT syndrome; Brugada syndrome or known history of QTc prolongation or torsade de pointes within 12 months of the subject entering the study.
Congenital long QT syndrome or a corrected QT interval (QTc) ?450 ms at Screening (unless secondary to pacemaker or bundle branch block).
Patients who have a mean resting correct corrected QT (QTc) interval using the Fridericia formula (QTcF) > 470 msec (as calculated per institutional standards) obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long QT syndrome; AZD1775 should not be given to patients who have a history of Torsades de pointes unless all risk factors contributed to Torsades have been corrected; AZD1775 has not been studied in patients with ventricular arrhythmias or recent myocardial infarction
Corrected QT interval (QTc) > 470 msec; excluded are patients who may develop prolongation of QTc; these conditions include patients with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy
Mean resting corrected QT interval (QTc), calculated using Fridericia’s formula, > 470 msec obtained from 3 electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of the patient entering in the study
Have Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 (male), or history of congenital long QT syndrome.
Corrected QT (QTc) interval >= 450 msec at baseline or history of congenital long QT syndrome or uncorrectable electrolyte abnormalities
Corrected QT interval (QTc) > 480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes
History of congenital long QT syndrome or corrected QT interval (QTc) greater than (>) 450 milliseconds at screening
Subject has Long corrected QT interval (QTc) Syndrome at Screening.
History of congenital long QT syndrome or a corrected QTc interval >= 450 msec at baseline
Prolonged corrected QT (QTc) interval (>= 450 msec) as calculated by Bazett’s formula, or patients with a history of congenital long QT syndrome or uncorrectable electrolyte abnormalities
Mean QTc > 500 msec (with Bazett’s correction) in screening electrocardiogram or history of familial long QT syndrome
History of congenital long QT syndrome, or a baseline >470 msec QTcF abnormality (average of the triplicate reading).
Baseline prolongation of QT/corrected QT (QTc) interval, i.e., defined as an average QTc interval > 450 msec calculated using the Fridericia formula for QT correction; long QT syndrome; or the required use of concomitant medication that may cause torsade de pointes
Corrected QT interval (QTc) >470 msec (as calculated by Fridericia correction formula) at study entry or congenital long QT syndrome.
History of congenital long QT syndrome or mean corrected QTc interval > 450 msec at baseline
History of congenital long QT syndrome or QTc > 470 msec
Have Fridericia-corrected QT interval > 470 milliseconds (msec) (female) or > 450 msec (male), or history of congenital long QT syndrome
Corrected QT (QTc) interval ? 450 msec at baseline or history of congenital long QT syndrome or uncorrectable electrolyte abnormalities. (Patients with well controlled atrial fibrillation are exempt from this criteria.)
Patients must have corrected QT (QTC) interval =< 480 msec on electrocardiogram (EKG) at baseline; patient with congenital long QT syndrome are not eligible
Subjects with a high probability of Long QT Syndrome or QTc interval prolongation of more than or equal to 501 msec on at least two separate ECGs, following correction of any electrolyte imbalance.
Any of the following cardiac abnormalities or history:\r\n* Clinically significant abnormal 12-lead electrocardiograph (ECG), QT interval corrected using Fridericia's method (QTcF) > 450 msec\r\n* Inability to measure QT interval on ECG\r\n* Personal or family history of long QT syndrome\r\n* Implantable pacemaker or implantable cardioverter defibrillator\r\n* Resting bradycardia < 55 beats/min
Mean resting corrected QT interval (QTc), calculated using Fridericia’s formula, > 470 msec obtained from 3 electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or torsade de pointes within 12 months of the patient entering in the study
Corrected QT interval (QTc) > 470 msec (as calculated by Fridericia correction formula) at study entry or congenital long QT syndrome
Patients with history of long QT syndrome, uncorrectable electrolyte abnormalities, or corrected QT (QTc) > 500 msec