[c09aa8]: / clusters / 9knumclustersv2 / clust_689.txt

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Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< ms within days before registration
Prolonged Fridericia's corrected QT interval (QTcF) > ms for men and > ms for women at Screening.
Baseline corrected Fridericia QT (QTcF) >= ms (males) or >= ms (females)
Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > milliseconds (ms) for males and > ms for females based on triplicate ECG.
Prolonged Fridericia's corrected QT (QTcF) > ms for men and > ms for women at screening.
Baseline QT interval corrected with Fridericia's method (QTcF) > ms Part Only:
QTc Fridericia (QTcF) > ms
Mean QT interval corrected for heart rate (QTc) >= ms calculated from an electrocardiogram (ECG) using Fridericias Correction (QTcF)\r\n* At screening, a single ECG will be obtained on which QTcF must be < ms; in case of clinically significant ECG abnormalities, including a QTcF value > ms, additional -lead ECGs should be obtained over a brief period (eg, minutes) to confirm the finding
Subjects must have a -lead electrocardiogram (EKG) showing no active ischemia and Fridericia's corrected QT interval (QTcF) less than ms.
Prolongation of corrected QT using Fridericia's formula (QTcF) interval to > ms
Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment Has a corrected QT by Fridericia's formula (QTcF), of > ms based on a triplicate -lead ECG
Mean QT interval corrected for heart rate using Fridericias formula (QTcF) >= ms; abnormality must be confirmed on electrocardiography (ECG)s
QT interval corrected for heart rate using Fridericias formula (QTcF) >= ms; (any clinically significant abnormalities detected require triplicate electrocardiogram [ECG] results and a mean QT interval corrected for heart rate using Fridericias formula (QTcF) >= ms calculated from ECGs)
QT interval corrected for heart rate using Fridericias formula (QTcF) >= ms. Any clinically significant abnormalities detected, require triplicate electrocardiogram (ECG) results and a mean QT interval corrected for heart rate using Fridericias formula (QTcF) >= ms calculated from ECGs.
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) >= ms or presence of a left bundle branch block (LBBB); if the QRS duration > ms, the JTc can be used in place of the QTcF; the JTc must be < ms
Have normal QT interval on electrocardiogram (ECG) evaluation QT corrected Fridericia (QTcF) of =< ms in males or =< ms in females
?lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula > ms in males or > ms in females at screening or history of long QT interval corrected syndrome.
Baseline corrected QT interval (corrected QT interval by Fridericia's formula [QTcF]) < ms
Subjects with prolongation of corrected QT interval by Fridericias method (QTcF) at rest, where the mean QTcF interval is > milliseconds (ms) for males and > ms for females based on triplicate electrocardiogram (ECG)
Have normal QT interval corrected (Frederica) (QTcF) interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of ? ms in males or ? ms in females.
Fridericia corrected QT (QTcF) correction unmeasurable or > ms on screening ECG (Note: If a patient has a QTcF interval > ms on screening ECG, the screening ECG may be repeated twice [at least hours apart] for a total of ECGs; the average QTcF from the three screening ECGs must be =< 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 > ms for males or > ms for females based on triplicate electrocardiograms (ECGs).
Corrected QT interval using Fridericia's formula (QTcF) interval less than or equal to ms (Phase II only)
Corrected QT for Fridericia (QTcF) interval greater than ms that is not correctable to less than ms such as with cessation of a causative medication, etc
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening QTcF interval > ms is excluded. In the event that a single QTcF is > ms, the subject may enroll if the average QTcF for the ECGs is < ms. For patients with an intraventricular conduction delay (QRS interval >ms), the JTc interval may be used in place of the QTcF with Sponsor approval. The JTc must be < 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 > ms on screening ECG.
For screening electrocardiographs (ECGs), exclude patients with a Fridericia's corrected QT interval (QTcF) > ms, or JTc > ms for those with an intraventricular conduction delay. If the screening ECG has a QTcF > ms, eligibility can be confirmed if the average of ECGs done minutes apart have an average QTcF < ms
Corrected QT using Fridericia's formula (QTcF) =< ms
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > ms =< days before the first dose of study treatment
Cardiac ejection fraction >= %, and Fridericia's formula corrected QT (QTcF) < ms (male) or < 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 Fridericias formula (QTcF) interval > ms is excluded; subjects with left bundle branch block are excluded
Subjects who have a corrected QT (Fridericia's correction formula [QTcF]) interval > milliseconds (ms) (CTCAE grade > ) determined by the electrocardiogram (ECG) recorders algorithm on the screening ECG
Subjects with mean of triplicate Fridericia-corrected QT interval (QTcF) > ms at Screening based on central reading.
For participants receiving alectinib: baseline Fridericias corrected QT interval (QTcF) greater than (>) milliseconds (ms) or symptomatic bradycardia.
QTcF values higher than ms at screening
Subjects with mean QTcF interval > ms.
Fridericias Corrected QT interval (QTcF) prolongation > 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 ECGs taken at screening.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > ms within days before treatment initiation
Subject with mean Fridericia-corrected QT interval (QTcF) > ms at screening based on central reading.
A screening Fridericia corrected QT interval (QTcF) >= ms (men) or >= ms (women)
A screening Fridericia corrected QT interval (QTcF) ? ms (men) or ? ms (women).
Baseline corrected QT interval using Fridericia's formula (QTcF) > 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 ? ms in males or ? ms in females.
QT interval corrected for heart rate by Fridericia's formula (QTcF) ? ms
Subject has Fridericia-corrected QT interval (QTcF) > ms at Screening based on central reading.
Patient has a corrected QT interval (QTcF) > ms at screening
Corrected QT interval corrected for Fridericia's formula (QTcF) < ms
Corrected QT interval according to Fridericia (QTcF) prolongation > 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 Electrocardiogram (ECGs) taken at screening.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > ms within days before randomization
The patient has a corrected QT interval (corrected QT using Fridericia formula [QTcF]) > ms within days before randomization; if QTcF is >= ms by Bazett formula, this must be confirmed by the Fridericia formula
Normal QT Fridericia-corrected interval (QTcF) ? ms for males and ? ms for females
QT-interval corrected according to Fridericia's formula (QTcF) ? ms on electrocardiogram (ECG) at Screening
Clinically significant abnormal -lead ECG, QT interval corrected using Fridericia's method (QTCF) > ms
Subject has QTcF interval > ms on -lead ECG at screening.
Normal QT interval corrected (Fridericia) (QTcF) on screening electrocardiogram (ECG) evaluation, defined as QTcF of =< ms in males or =< ms in females
Clinically significant abnormal -lead ECG, QT interval corrected using Fridericia's method (QTcF) > ms
Corrected QT interval (QTc) of > milliseconds (ms) in males and > 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 > ms for males and > ms for females based on triplicate electrocardiogram (ECG).
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > ms within days before week day
QT interval corrected for heart rate using Fridericias formula (QTcF) >= ms; any clinically significant abnormalities detected, require triplicate electrocardiography (ECG) results and a mean QT interval corrected for heart rate using Fridericias formula (QTcF) >= ms calculated from ECGs
Fridericia's corrected QT (QTcF) prolongation > 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 electrocardiograms (ECGs) taken at screening\r\n* NOTE: The formula used to calculate QTcF can be physicians choice, but it must be used consistently throughout the study
Subject has a QTcF > ms (corrected) in the screening or baseline ECG.
A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation (Fridericia corrected QT interval [QTcF] > ms), a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 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 > ms for females and > 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 > milliseconds (ms) based on triplicate electrocardiograms (ECGs)