Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from electrocardiograms (ECGs) using Fridericia’s correction; abnormal ECGs should be repeated
Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration
The subject has a baseline corrected QT interval =< 480 ms
Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.
Patients with a prolonged corrected QT interval (QTc) interval (>= 450 ms)
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).
Baseline corrected QT (QTc) < 480 ms
Baseline corrected QT (QTc) =< 500 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;
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
Baseline corrected Fridericia QT (QTcF) >= 450 ms (males) or >= 470 ms (females)
Congenital long QT syndrome or a corrected QTc interval ? 470 ms at screening
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.
Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiography (ECG), e.g. complete left bundle branch block, third-degree heart block, second-degree heart block, QT interval corrected by Fridericia’s formula (QTcF) of >= 450 ms in males or >= 470 ms in females
Prolonged Fridericia's corrected QT (QTcF) > 450 ms for men and > 470 ms for women at screening.
Prolongation of QT corrected (QTc) interval to >480 milliseconds (ms)
Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms Part 2 Only:
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
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
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
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
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)
Has a mean QT interval corrected for heart rate (QTc) ? 470ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s Correction
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).
Mean QT interval corrected for heart rate (QTc) >= 470 ms using Fridericia’s correction.
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
Subjects must have a 12-lead electrocardiogram (EKG) showing no active ischemia and Fridericia's corrected QT interval (QTcF) less than 480 ms.
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
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction.
Prolongation of corrected QT using Fridericia's formula (QTcF) interval to > 480 ms
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
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
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).
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)
Has a mean QTcF prolongation >470 ms for females and >450 ms for males in three successive Screening measurements.
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)
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
Screening 12-lead ECG with a measurable QTc interval according to Fridericia's correction >450 ms.
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)
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)
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
QT interval corrected for heart (QTc) >= 470 ms calculated from 1 electrocardiogram (ECG) using Fridericia's correction
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s correction
Have normal QT interval on electrocardiogram (ECG) evaluation QT corrected Fridericia (QTcF) of =< 450 ms in males or =< 470 ms in females
Mean QT interval corrected for heart rate (corrected QT interval [QTc]) >= 470 ms calculated from electrocardiogram (in triplicate, if applicable) 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)
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction.
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
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.
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction
Corrected QT interval ([QTc] Fridericia) > 480 ms
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
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)
Screening 12-lead electrocardiogram (ECG) with a measurable QTc interval according to Fridericia’s correction > 450 ms
Baseline corrected QT interval (corrected QT interval by Fridericia's formula [QTcF]) < 480 ms
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
Baseline Fridericia's corrected QT (QTcF) interval of > 470 ms, participants with baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia > 100 beats per minute
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
Patients with clinically relevant abnormal electrocardiography (ECG) findings, including abnormal corrected QT interval (QTc) > 500 ms on screening ECG (note: if a patient has a QTc interval > 500 ms on screening ECG, the screening ECG may be repeated twice [at least 24 hours apart] for a total of 3 ECGs)
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
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)
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
Patients with baseline corrected QT (QTc) > 470 ms or patients with symptomatic bradycardia
Congenital QT syndrome, corrected QT (QTc) > 500 ms
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.
Corrected QT (QTc) =< 480 ms
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).
Corrected QT interval (QTc) > 500 ms at baseline
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 (QTc) interval =< 480 ms by electrocardiogram (EKG)
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.
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).
QTcF interval >470 ms on screening ECG.
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
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)
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
Prolongation of QTc interval to >480 milliseconds (ms)
Corrected QT (QTc) interval prolongation greater than 500 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.
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
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
Patients who have a mean corrected QT (QTc) interval > 450 ms at base line will be excluded; concomitant use of agents that prolong the QT interval will be avoided
To be performed within 28 days prior to day 1 of protocol therapy: Corrected QT (QTc) interval =< 480 ms (12 lead-electrocardiography [ECG])
Corrected QT using Fridericia's formula (QTcF) =< 450 ms
Prolonged corrected QT interval (QTc) > 450 milliseconds (ms) at the screening visit
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms =< 7 days before the first dose of study treatment
Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of =< 470 milliseconds (ms)
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
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
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Bazett's formula
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)
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
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
A prolonged QTc of >= 480 ms interval on electrocardiogram
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
Corrected QT interval (QTc) greater than 460 ms at baseline
Subjects with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
Subjects with heart-rate corrected QT (QTc) interval ?450 ms or other factors that increase the risk of QT prolongation or arrhythmic events.
For participants receiving alectinib: baseline Fridericias corrected QT interval (QTcF) greater than (>) 470 milliseconds (ms) or symptomatic bradycardia.
Baseline corrected QT interval (QTc) < 480 ms
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
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).
QTcF values higher than 450 ms at screening
Congenital long QT syndrome or a corrected QTc interval ?450 ms at the Screening visit.
Subjects with mean QTcF interval > 500 ms.
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
Increased corrected QT (QTc) interval (QTc > 470 ms), patients with baseline resting bradycardia < 45 beats per minute (bpm), or baseline resting tachycardia > 100 bpm
Have QTc >450 ms or heart rate ?100 bpm or ?45 bpm at screening
Corrected QT interval (QTc) =< 500 milliseconds (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.
Prolongation of QTc interval to greater than 480 ms
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)
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 ?470 ms
Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Frederica’s Correction
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
A screening Fridericia corrected QT interval (QTcF) ? 450 ms (men) or ? 470 ms (women).
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
Corrected QT interval (QTc) =< 480 ms within 14 days before enrollment
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
Patients will be required to have a baseline electrocardiogram (EKG) prior to the start of treatment; patients with a corrected QT (QTc) > 480 millisecond (ms) are excluded from the study
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.
Baseline corrected QT interval (QTc) =< 480 ms
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
QRS interval ? 110ms
QT interval corrected for heart rate by Fridericia's formula (QTcF) ? 480ms
PR interval ? 200ms
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.
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
Patient has a corrected QT interval (QTcF) > 500 ms at screening
Electrocardiogram (ECG) corrected QT (QTC) interval < 470 ms
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.
Patients must have a corrected QT (QTc) interval < 450 ms on baseline electrocardiogram (EKG)
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
Patient must not have corrected QT (QTc) > 500 ms within 14 days before enrollment
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization
Patients with a baseline corrected QT interval (QTc) > 500 ms
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
Corrected QT (QTc) interval =< 470 ms on screening electrocardiogram (ECG)
Patients must not have a prolonged PR interval (defined as > 200 ms).
For patients on mefloquine arm, a baseline electrocardiogram (EKG) without evidence of prolonged corrected QT (QTc) interval > 450 ms or clinically significant arrhythmia must be obtained within 14 days prior to registration
For mefloquine arm, patients with evidence of QTc interval > 450 ms or clinically significant arrhythmia on baseline EKG obtained within 14 days of registration will be ineligible for protocol enrollment
Mean corrected QT (QTc) > 450 ms at time of screening
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)
Normal QT Fridericia-corrected interval (QTcF) ?450 ms for males and ?470 ms for females
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
QT-interval corrected according to Fridericia's formula (QTcF) ? 450 ms on electrocardiogram (ECG) at Screening
Baseline corrected QT interval (QTc) =< 480 ms
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
Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms)
ECG: QTc interval ? 450 ms
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) > 450 ms
Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction formula).
Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s correction
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
Subject has QTcF interval > 450 ms on 12-lead ECG at screening.
Corrected QT interval (QTc) greater than 450 ms
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
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
NON-PROGRESSED DIPG (STRATUM 2): Patient has a QTc interval < 450 ms
Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
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
The subject has a corrected QT interval (QTc) > 480 ms at screening or has a history of long QT syndrome
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
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
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).
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.
Electrocardiogram (12-lead ECG) QTc ? 480 ms
Baseline QTc > 470 ms or baseline symptomatic bradycardia < 45 beats per minute
QTcF corrected with Frederica's or Bazett's formula QTcB >450 ms for males and >470 ms for females on screening ECG.
QTc interval prolongation >450ms for males and >470 ms for females.
Patients with a mean QTc interval greater than 480ms are excluded. Avoid concomitant administration of agents that prolong the QT interval, except at the discretion of the investigator. If advised, patients should discontinue the use of these agents at least 2 weeks before the study begins. No uncontrolled arrhythmias.
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
Patient has a QT interval prolongation > 480 ms at screening. If a patient has a prolonged QT interval and the prolongation is deemed to be due to a pacemaker upon Investigator evaluation (ie, the patient otherwise has no cardiac abnormalities), then the patient may be eligible to participate in the study following discussion with the Medical Monitor.
A baseline ECG QTc > 470 ms
Baseline corrected QT interval (QTc) > 450 ms
QTcF >450 ms for males and >470 ms for females on screening ECG
Prolonged QTC interval >450ms
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)
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
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
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);
Mean QT interval corrected for heart rate (QTc) < 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
PATIENTS: History of prolonged corrected QT (QTc) interval (> 500 ms)
Patients with corrected QT (QTc) interval greater than 450 ms
Q-T interval of =< 450 ms as measured by electrocardiography (EKG)
Patients must not have baseline corrected QT (QTc) interval >= 500 ms
Baseline Fridericia corrected QT (QTcF) > 480 ms; NOTE: this criterion does not apply to patients with a left bundle branch block
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
Mean QT interval corrected for heart rate (corrected QT [QTc]) >= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction
Subject has a QTcF > 480 ms (corrected) in the screening or baseline ECG.
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)
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
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)
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
Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
Prolonged QTc interval defined as greater than 480 ms.
Subjects with QTc interval > 480ms.
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.
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).
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).