[c09aa8]: / clusters / 9knumclustersv2 / clust_768.txt

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Patients must have corrected QT (QTc) =< msec by electrocardiogram (ECG) (corrected using the Bazetts formula) within days prior to registration
Corrected QT interval (QTc) < milliseconds (msec) on a -lead electrocardiogram (ECG) =< days before registration
Screening electrocardiogram (ECG) with a corrected QT interval (QTc) > msec
Rate-corrected QT interval of electrocardiograph (QTc) > msec on a -lead electrocardiography (ECG) during screening
Adequate cardiac conductivity with corrected QT interval (QTC) of < ms on screening electrocardiogram (ECG)
Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).
Mean resting corrected QT (QTc) interval using the Fridericia formula (QTcF) > ms (i.e., grade or higher) for males and > ms for females on electrocardiogram (ECG) prior to initiation of study treatment obtained from electrocardiograms (ECGs) obtained - minutes apart at study entry, or history of congential long QT syndrome\r\n* If baseline QTc on screening ECG is > ms for males or > 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) < bpm or > 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 - bpm, manual measurement of QTc interval is NOT required
Have a mean QT interval corrected for heart rate (QTc) of ? milliseconds on screening electrocardiogram (ECG) as calculated using the Bazett's formula at several consecutive days of assessment.
Electrocardiogram (EKG) documenting corrected QT (QTc) interval < mili (m)second and no clinically significant arrhythmia
Corrected QT Interval (QTc) > milliseconds (msec) on a -lead ECG obtained during the screening period\r\n* Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
QT interval corrected for rate (QTc) > msec on the electrocardiogram (ECG) obtained at Screening
Electrocardiogram (ECG) corrected QT (QTC) < msec
Have QT corrected interval of > milliseconds (msec) on screening electrocardiogram (ECG)
Corrected QT (QTc) interval ? msec on screening electrocardiogram (ECG)
Significant cardiac disease as determined by the investigator including:\r\n* Known or suspected cardiac amyloidosis\r\n* Congestive heart failure of class III or IV of the New York Heart Association (NYHA) classification\r\n* Uncontrolled angina, hypertension or arrhythmia\r\n* Myocardial infarction in the past months\r\n* Any uncontrolled or severe cardiovascular disease\r\n* Corrected QT Interval (QTc) > milliseconds (msec) on a -lead electrocardiogram (ECG) obtained during the screening period. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
Have normal QT interval on electrocardiogram (ECG) evaluation QT corrected of =< ms in males or =< ms in females obtained from electrocardiograms (ECGs), using the screening clinic ECG machine-derived corrected QT (QTc) value
Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of < msec
Cardiac electrophysiologic stability as defined by an electrocardiogram (ECG) with a corrected QT (QTc) interval < msec at screening
Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal electrocardiogram (ECG).
Corrected QT (QTc) > milliseconds (msec) on a -lead ECG obtained during the screening period; Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
QT interval corrected for heart (QTc) >= ms calculated from electrocardiogram (ECG) using Fridericia's correction
Electrocardiogram (ECG) - corrected QT (QTc) < msec, within weeks of registration (except where specified otherwise)
Screening rate-corrected QT interval (QTc) must be <msec and a resting heart rate of at least - bpm via a standard -lead ECG within days prior to registration.
Corrected QT interval (QTc) > msec on screening electrocardiogram; if QTc prolongation is felt to be related to electrolyte imbalance, an electrocardiogram (EKG) can be repeated after correction of electrolytes
Rate-corrected QT interval of electrocardiograph (QTc) > msec on a -lead ECG during screening
Screening -lead electrocardiogram (ECG) with a measurable QTc interval according to Fridericias correction > ms
Normal electrocardiogram with corrected QT (QTc) =<
Resting electrocardiogram (ECG) with corrected QT interval (QTc) > msec (Fridericias scale)
Patients with clinically relevant abnormal electrocardiography (ECG) findings, including abnormal corrected QT interval (QTc) > ms on screening ECG (note: if a patient has a QTc interval > ms on screening ECG, the screening ECG may be repeated twice [at least hours apart] for a total of ECGs)
QT interval corrected for rate (QTc) ? msec on the electrocardiogram (ECG) obtained at Screening
Corrected QT (QTc) interval > ms (>= grade ) on a -lead electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG is >= grade :\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 < beats per minute (bpm) or > 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 - bpm, manual read of the QT interval and correction to QTcF is not required
Mean resting corrected QT interval (QTc) > msec, obtained from ECGs, using the screening clinic ECG machine-derived QTc value.
QT interval corrected for rate (QTc) ? msec on the electrocardiogram (ECG) obtained at Screening (average of readings)
Rate-corrected QT interval of electrocardiograph (QTc) > msec on a -lead electrocardiogram (ECG) during screening
Corrected QT(c) >= ms (>= grade ) on electrocardiogram (ECG) prior to initiation of treatment\r\n* If baseline QTc on screening ECG meets exclusion criteria:\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 HR - bpm, no manual read of QTc is required\r\n* For patients with baseline HR < or > bpm, manual read of QT by cardiologist is required, with Fridericia correction applied to determine QTc
Screening electrocardiogram (ECG) with a corrected QT interval (QTc) > msec confirmed by central laboratory prior to enrollment to the study
Corrected QT (QTc) > ms (grade or greater) on screening electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG meets exclusion criteria on screening assessment:\r\n** Check potassium and magnesium 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 a heart rate (HR) - bpm, no manual read of QT is required\r\n** For patients with baseline HR < or > bpm, manual read of QT by cardiologist is required using Fridericia correction
Corrected QT (QTc) > milliseconds (msec) on a -lead ECG obtained during the Screening period\r\n* Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
Mean resting corrected QT interval (QTc) > millisecond (msec), obtained from ECGs recordings, using the screening clinic ECG machine-derived QTc value.
Has a corrected QT interval (QTc) > ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant.
QT interval corrected for rate (QTc) > msec for on the ECG obtained at Screening using Fridericia method for QTc calculation
Electrocardiogram (ECG) corrected QT (QTc) =< msec
To be performed within days prior to day of protocol therapy: Corrected QT (QTc) interval =< ms ( lead-electrocardiography [ECG])
Corrected QT (QTc) interval > ms on screening -lead electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG meets exclusion criteria:\r\n** Check calcium, potassium, and magnesium serum levels\r\n** Correct any identified hypocalcemia, hypokalemia, and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to prolonged QTc interval\r\n* For patients with heart rate (HR) - beats per minute (bpm), manual read of QTc is not required\r\n* For patients with a baseline HR < bpm or > bpm, manual read of the QT interval by a cardiologist is required, with Fridericia correction applied to determine QTc (ie, QTcF)
Inability to measure QT interval on ECG
Patient must have an electrocardiogram (ECG) performed within days prior to registration; patient must not have mean corrected QT (QTc) > msec (with Bazetts correction) in screening electrocardiogram, or other significant ECG abnormality, New York Heart Association (NYHA) classification III or IV; patient must not require concurrent use of drugs or biologics with proarrhythmic potential
Patient must have a corrected QT interval (QTc) interval < msec on the lead electrocardiogram (ECG) within days prior to registration, patients with asymptomatic or incidental bundle branch blocks may have QTc measured by a cardiologist or standard formulas such as Bazetts or Fridericias to adjust for pre-existing blocks
Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: participants with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible). A clinically significant ECG abnormality, including a marked prolonged QT/QTc interval (eg, a repeated demonstration of a QTc interval of greater than ms).
Corrected QT interval (QTc) > milliseconds (msec) on a -lead electrocardiography (EKG) obtained during the screening period; if a machine reading is above this value, the EKG should be reviewed by a qualified reader and confirmed on a subsequent EKG
History of prolonged QT syndrome or electrocardiogram (ECG) at screening QT interval corrected for heart rate (QTc) of > ms with Bazetts or Fridericias formula
Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< . seconds by Bazetts calculation at screening
Mean resting corrected QT interval (QTc) > msec, obtained from ECGs, using the screening clinic ECG machine-derived QTcF value.
The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB)
For purposes of this data analysis, Bazett's formula will be used as the primary method of calculating the corrected QT interval. The QTc should be based on either a single Electrocardiogram (ECG) or an average of sequential ECGs obtained within hours of each other.
Patients with baseline corrected QT (QTc) prolongation greater than grade are excluded from this study; patients with grade QTc elevation are eligible but must be monitored with electrocardiogram (ECG) (EKG) exams, for the first cycles of treatment; eribulin time to maximum concentration (Cmax) after infusion is about minutes, and half life is minutes; ECG (EKG) should be performed between to minutes after eribulin administration (on day and day of treatment); continued ECG (EKG) monitoring beyond cycle can be done at the discretion of the treating physician
Patients must have a baseline electrocardiogram (ECG) showing corrected QT (QTc) interval =< msec within days prior to registration
Electrocardiogram (ECG) corrected QT (QTC) interval < ms
Corrected QT interval using Bazett's formula (QTcB) > milliseconds (msec) on a -lead electrocardiogram (ECG) obtained during the screening period; if a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of < msec
Inability to determine the QT interval on ECG
Corrected QT (QTc) interval =< ms on screening electrocardiogram (ECG)
Inability to monitor the QT interval on electrocardiogram (ECG)
Corrected QT (QTc) =< msec on baseline electrocardiogram (ECG)
Baseline corrected QT (QTc) > msec or other clinically significant baseline electrocardiogram (ECG) abnormality
Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult.
Inability to measure QT interval on ECG
Has a corrected QT interval (QTc) > ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
Grade >= QT interval corrected (QTc) prolongation on screening electrocardiogram (ECG) within days of enrollment, or history of ventricular arrhythmia
QT/QTc interval > msec, before CD treatment administration, as determined by screening electrocardiogram (ECG)
QT/QTc interval > msec, as determined by screening ECG performed no earlier than week before CD
Corrected QT (QTc) interval >= ms (ie, grade or higher) on electrocardiogram (ECG) prior to initiation of study treatment\r\n* If baseline QTc on screening ECG is >= ms (ie, grade or higher):\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm QTc interval\r\n* For patients with baseline heart rate (HR) < beats per minute (bpm) or > 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 - bpm, manual measurement of QTc interval and use of Fridericia calculation is NOT required
Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
Cardiac function: -lead electrocardiogram (ECG) with normal tracing, or non-clinically significant changes that do not require medical intervention; corrected QT (QTc) interval is to be < msec
Corrected QT interval (QTc) prolongation (defined as a QTc interval > msec) or other significant electrocardiogram (ECG) abnormalities
Patients with corrected QT (QTc) prolongation (defined as a QTc interval equal to or greater than msec) or other significant electrocardiogram (ECG) abnormalities are excluded
Have corrected QT (QTc) interval of > milliseconds on screening electrocardiogram (ECG).
Inability to measure QT interval on ECG
Corrected QT interval (QTc) > milliseconds in a -lead electrocardiogram (ECG) during screening.
Baseline corrected QT interval (QTc) > msec (average of triplicate electrocardiogram [ECG] recordings); a consistent method of QTc calculation must be used for each patient's QTc measurements; QTcF (Fridericia's formula) is preferred
Important abnormalities of the ECG that may interfere with the interpretation of QTc interval changes at screening
Electrocardiogram (-lead ECG) QTc ? ms
QT/QTc interval > msec, as determined by screening electrocardiogram (ECG)
Serious cardiac condition such as myocardial infarction within the past months, unstable angina, or Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA); have ECG abnormalities including baseline -lead ECG with Fridericia-corrected QT interval (QTcF) > msec (female) or > msec (male), a history of congenital long QT syndrome, or any ECG abnormality that, in the opinion of the Investigator, would preclude safe participation in the study
Any of the following cardiac abnormalities or history:\r\n* Clinically significant abnormal -lead electrocardiograph (ECG), QT interval corrected using Fridericia's method (QTcF) > 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 < beats/min
Corrected QT interval (QTc) > milliseconds on baseline electrocardiogram (ECG) (using corrected QT interval using Fridericia [QTcF] or Bazett [QTcB]); if electrolytes are abnormal, they may be corrected and baseline ECG should be repeated
Prolonged corrected interval between the Q wave and T wave (QTc) by Fridericia's correction factor (QTcF) interval on pre-entry ECG ? ms (average of ECG readings done in triplicate);
Patients must have electrocardiogram with corrected QT (QTc) with correction within days prior to registration
-lead ECG with QTc interval within defined limit
Have corrected QT interval of > millisecond (msec) on screening electrocardiogram (ECG).
Have corrected QT interval of > milliseconds on screening electrocardiogram (ECG).