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a b/clusters/3009knumclusters/clust_208.txt
1
Corrected QT (by Bazett's formula [QTcB]) interval < 450 msec
2
Patients must have QTcF (by Fridericia calculation) < 480/msec based on electrocardiogram (EKG) performed within 28 days prior to registration
3
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)
4
Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, or corrected QT interval (Fridericia’s correction; QTcF) > 470 msec
5
Patients must not have a screening corrected QT using Fridericia's formula (QTcF) interval > 500 milliseconds (by Fridericia calculation) based on the average of triplicate electrocardiogram (EKG) performed within 7 days prior to registration; note that triplicate EKG is required at other time points
6
QT interval corrected through use of Fridericia's formula (QTcF) > 470 milliseconds
7
Fridericiaís corrected QT interval (QTcF) >/= 480
8
Baseline Fridericia's correction formula (QTcF) < grade 2
9
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
10
Subjects showing an average QTc interval over 3 consecutive electrocardiograms (ECG) >450 msec in males and >470 msec in females at screening (? 480 msec for subjects with bundle branch block (BBB) are not eligible.
11
12-lead Electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ? 470 msec Fridericia Formula.
12
Patient with Frederica's (QTcF) formulas (QTcF) ?450 msec;
13
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)
14
Prolongation of corrected QT [QTcF (Fridericia's corrected QT interval)] interval to greater than 480 msec when electrolytes balance is normal
15
QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 msec or <480 milliseconds (msec) for subjects with bundle branch block.
16
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)
17
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
18
Patients with a QT interval > 480 msec (using the Bazett's formula) within 28 days prior to registration are not eligible
19
Males with mean QTcF values of > 450 msec and females with QTcF values of > 470 msec following 3 ECGs conducted 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes; or patients who are on medications known to cause prolonged QT intervals on ECG;
20
Corrected QT interval by Fredericia (QTcF) > 500 msec within 1 month before the first dose of study treatment:\r\n* Three electrocardiograms (ECGs) must be performed for eligibility determination. If the average of these three consecutive results for QTcF is =< 500 msec, the subject meets eligibility in this regard
21
Have a heart-rate corrected QT interval using Fridericia's method (QTcF) >470 msec.
22
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.
23
QTcF > 460 msec on Screening electrocardiogram (ECG)
24
Fredericia-corrected QT interval (QTcF) >470 msec (female) or >450 msec (male), or history of congenital long QT syndrome.
25
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;
26
Subjects with corrected QT using Fridericia's formula (QTcF) interval of >= 450 msec if male and >= 470 msec if female; other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, chronic hypokalemia, family history of long QT interval syndrome) at screening; subjects with bundle branch block should be reviewed by the principal investigator for potential inclusion
27
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)
28
Cardiac Function: Fridericia's correction formula (QTcF) < 480 milliseconds (Fridericia correction), and ejection fraction (EF) >= 50%
29
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
30
Consistent corrected QT (QTc) > 450 msec for men and > 470 msec for women by Fridericia formula, on 3 separate electrocardiograms (ECGs)
31
Participant has a Fridericia-corrected QT interval (QTcF) > 450 msec (average of triplicate determinations) per central read.
32
Participant has a QTcF interval > 450 msec (average of triplicate determinations) by central read.
33
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.
34
Corrected QT interval (QTc) < 470 msec (as calculated by the Fridericia correction formula [QTcF]).
35
Medical history of uncontrolled but clinically significant abnormal cardiac conduction abnormalities at electrocardiogram (ECG), any history or evidence of long QT syndrome or QTcF interval >450 msec for males and ?470 msec for females (according to Fridericia's correction) at screening
36
Fridericia’s corrected QT (QTcF) value of =< 470 msec on screening electrocardiogram (EKG) within 14 days prior to start of protocol therapy.
37
Mean resting corrected QT interval (QTcF) >470 msec obtained from 3 ECGs
38
Fridericia's corrected QT interval (QTcF) =< 450 msec
39
QTc interval calculated according to Fridericia's formula (QTcF = QT/RR0.33; RR = RR interval) of ? 450 msec on screening electrocardiogram (ECG).
40
Corrected QT (QTc) interval (using Fridericia’s correction formula, QTcF, if prolonged) > 470 msec
41
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
42
Resting electrocardiogram (ECG) with corrected QT interval by Fridericia (QTcF) > 470 msec or family history of long QT syndrome
43
12-lead Electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ? 470 msec
44
Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec.
45
QTcF <500 msec
46
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
47
Mean QT interval ? 470 msec
48
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.
49
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
50
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Patients with a mean QTcF interval of > 500 msec or receiving therapeutic agents known to prolong the QT interval
51
QT interval corrected for heart rate using Fridericia's formula (QTcF) =< 500 msec
52
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.
53
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
54
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
55
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.
56
Baseline electrocardiogram (EKG) shows corrected QT interval by Fredericia (QTcF) > 470 msec.
57
Corrected QT using Fridericia's formula (QTcF) prolongation.
58
Fridericia's correction formula (QTcF) > 500 msec within 1 month before the first dose of study treatment:\r\n* Three electrocardiography (ECG)s must be performed for eligibility determination; if the average of these three consecutive results for QTcF is =< 500 msec, the subject meets eligibility in this regard
59
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
60
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
61
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
62
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
63
Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening electrocardiogram (EKG) > 480 msec
64
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)
65
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)
66
Corrected QT interval calculated by the Bazett formula (QTcB) > 480 msec
67
QTcF interval at screening <450 msec (using Fridericia's correction)
68
A corrected QT interval (QTc) ? 480 msec using the Fridericia's formula (QTcF)
69
Fridericia's corrected QT interval (QTcF) > 470 msec using the Fredericia formula
70
Corrected QT Interval Fridericia (QTcF) > 450 msec (both genders)
71
Fridericia's correction formula (QTcF) > 480 msec (males and females)
72
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
73
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
74
Has a QT interval corrected by Fridericia's formula (QTcF) ?480 msec
75
Pre-treatment Fridericia's correction formula (QTcF) > 480 msecs
76
Evidence of currently uncontrolled cardiovascular conditions as listed in the protocol; acute myocardial infarction with 6 months before starting study drug; baseline QT interval (QTcF) greater than (>) 450 milliseconds (msec) (males) or > 475 msec (females); or abnormalities on baseline 12-lead electrocardiogram (ECG) that are considered clinically significant per investigator.
77
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
78
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.
79
QT interval corrected using Fridericia’s method (QTcF) < 460 msec
80
Patients with mean QTcF values of > 470 msec (in females) or > 450 msec (in males) following 3 ECGs conducted 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes; or patients who are on medications known to cause prolonged QT intervals on ECG.
81
Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds
82
QTcF >450 milliseconds (msec) or QTcF >480 msec for subjects with bundle branch block
83
Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) > 500 millisecond (msec)
84
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
85
Corrected QT interval using Fridericia's formula (QTcF) interval of > 450 msec at study entry; congenital long QT syndrome
86
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.
87
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
88
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)
89
Baseline QT Fridericia's correction formula (QTcF) ? 470 msec
90
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
91
A QT interval corrected for heart rate using the Fridericia’s formula (QTcF) >= 470 msec on screening exam
92
Fridericia's correction formula (QTcF) > 470 msec on screening electrocardiography (ECG) or congenital long QT syndrome
93
Patient has a QT interval adjusted by the Fridericia formula (QTcF) > 480 msec on screening electrocardiogram (ECG).
94
QT interval adjusted according to Fredericia (QTcF) > 480 msec on screening electrocardiogram (ECG)
95
QTcF interval ?450 msec using the mean of triplicate electrocardiograms (ECGs).
96
Known congestive heart failure and/ or a known decreased cardiac ejection fraction of < 45%. A baseline QT interval as corrected by Fridericia's formula (QTcF) > 480 msec, a complete left bundle branch block (defined as a QRS interval ? 120 msec in left bundle branch block form) or an incomplete left bundle branch block.
97
Corrected QC interval calculated using Fridericia's formula (QTcF) =< 500 msec; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
98
Has a QT interval corrected by Fridericia's formula (QTcF) =< 450 msec
99
Patients with a mean QT interval corrected by Bazett's formula (QTcB) > 450 msec in males and > 470 msec in females
100
At screening QT interval corrected by Fridericia's formula (QTcF) >= 450 msec
101
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's\n             method (QTCF) greater than 450 msec
102
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
103
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)
104
Corrected QT using the Fridericia formula (QTcF) < 470 msec
105
Subject has a corrected QT by the Fridericia formula (QTcF) > 480 msec on the screening electrocardiogram (ECG) (using the QTcF formula)
106
QT interval adjusted according to Fridericia (QTcF) > 480 msec on screening electrocardiography (ECG)
107
QT interval corrected by Fridericia's formula (QTcF) > 450 msec on screening electrocardiogram (ECG)
108
QT interval corrected for Fridericia formula (QTcF) at screening > 470 msec
109
Significant abnormalities on ECG at screening. QTcF >450 msec for males or >470 msec for females at screening
110
Has a QT interval corrected by Fridericia's formula (QTcF) ?450 msec
111
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.
112
Subjects with a QTcF interval of >470 msec; if the Screening ECG QTcF interval is >470 msec, it may be repeated, and if repeat <470 msec, the subject may be enrolled.
113
QTcF interval < 450 msec and mean resting heart rate 50-90 bpm
114
Screening 12-lead ECG with measurable QTc interval (according to either Fridericia's or Bazett's correction) of >=470 msec).
115
Mean resting corrected QT interval (QTc using Fridericia’s formula [QTcF]) > 470 msec
116
QTcF prolongation defined as a QTcF interval >470 msec or other significant ECG abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate <50 beats/min).
117
Has a QT interval corrected by Fridericia's formula (QTcF) ?480 msec
118
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
119
A baseline ECG QTcF > 470 msec
120
Has a QT interval corrected by Fridericia's formula (QTcF) less than or equal to (<=) 480 milliseconds (msec)
121
Any of the following ECG findings: Baseline QTcF interval >=450 millisecond (msec); Any clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
122
Has a QT interval corrected by Fridericia's formula (QTcF) ?480 msec
123
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.
124
Electrocardiogram (ECG) showing clinically significant abnormality at Screening or showing an average QTc interval ?450 msec in males and ?470 msec in females (?480 msec for subjects with Bundle Branch Block (BBB) over 3 consecutive ECGs).
125
Corrected QT interval > 480 msec (using the Fridericia formula)
126
QTcF > 470 msec on the screening ECG
127
12 lead ECG with QtcF interval ? 470 msec
128
QTcF interval at screening < 450 msec (using Fridericia's correction).
129
QTcF > 460 msec on screening Electrocardiography (ECG) (mean of triplicate recordings).
130
history or family history of long QT syndrome; 12-Lead electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant or QTcF ? 450 milliseconds, regardless of clinical significance, at screening. Abnormal ECG may be confirmed with one repeat assessment. For subjects with QTcF ? 450 msec on initial ECG, the mean of the two QTcF assessments will determine eligibility;
131
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)
132
Screening QTcF >450 msec or current medication known to prolong QT
133
A baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec, a complete left bundle branch block (defined as a QRS interval ? 120 msec in left bundle branch block form) or an incomplete left bundle branch block.
134
QTcF prolongation (defined as a QTcF > 450 msec)
135
QTcF >450 msec (males) or >470 msec (females).
136
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
137
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).
138
Corrected QT using Fridericia's correction formula (QTcF) =< 480 msec
139
Any of the following electrocardiogram (ECG) findings: Baseline QTcF >=450 millisecond (msec). NOTE: Any clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
140
The calculated Fridericia's corrected QT interval (QTcF) average of the triplicate electrocardiograms (ECGs) must be < 470 msec
141
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).
142
Mean resting corrected QT interval (Fridericia formula for QT interval correction [QTcF]) > 480 msec obtained from 3 electrocardiograms (ECGs)
143
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
144
Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value.
145
QTcF interval at screening >450 msec (using Fridericia's correction)
146
Fridericia's formula (QTcF), or another method, machine or manual overread.
147
Patients who have a resting electrocardiogram (ECG) with a Fridericia corrected QT (QTcF) interval of >= 470 msec at 2 or more time points within a 24 hour period or a family history of long QT syndrome
148
Impaired cardiac function or clinically significant heart disease, including any one of the following: a) angina pectoris within 3 months; b) acute myocardial infarction within 3 months; c) QT interval corrected with the Fridericia formula (QTcF) greater than 450 msec for males and greater than 470 msec for females on the screening electrocardiogram (ECG); d) a past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome; e) other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
149
On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.
150
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.
151
At Screening QTcF ?450 msec for males and ?470 msec for females.
152
Corrected QT interval using Bazett's formula (QTcB) > 470 milliseconds (msec) on a 12-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
153
QTcF > 480 msec
154
Screening electrocardiogram (ECG) with a QTcF > 450 millisecond (msec)
155
Impaired cardiac function or clinically significant heart disease, including any one of the following:\r\n* Angina pectoris within 3 months\r\n* Acute myocardial infarction within 3 months\r\n* QT interval corrected using Fridericia’s formula (QTcF) > 450 msec for males and > 470 msec for females on the screening electrocardiogram (ECG)\r\n* A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome\r\n* Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
156
QTcB ? 480 msec
157
Baseline Bazett's correction formula (QTcB) >= 470 msec
158
Screening electrocardiogram (ECG) with a corrected QT interval using Fridericia's formula (QTcFredericia)(QTcF) > 450 msec
159
QTcF >500 msec (males or females)
160
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
161
Clinically significant abnormality on electrocardiogram (ECG). The corrected QT interval (QTc, Fridericia) must be < 470 milliseconds for men and < 490 milliseconds for women (Must be confirmed by at least 2 additional 12-lead ECGs at least 2 minutes apart such that average manually over-read QTcF based on 3 ECGs exceeds stated thresholds)
162
Mean QTcF ?450 msec (for males) or ?470 msec (for females) at Screening
163
QTcF greater than 460 msec on Screening ECG (mean of triplicate recordings)
164
Baseline mean QTcF ? 450 msec (for males) or ? 470 msec (for females) at Screening.
165
Clinically relevant findings in the ECG such as a second-degree or third-degree atrioventricular (AV) block (subjects with AV block and pacemaker in place for >1 year and checked by a cardiologist within ?6 months before the first dose of study drug will not be excluded), prolongation of the QRS complex over 120 msec or of the QTc interval (Fridericia, QTcF) over 470 msec (subjects with a pacemaker and QRS interval over 120 msec or QTc inverval over 470 msec may be enrolled on a case-by-case basis, following a discussion between the investigator and the sponsor).
166
A QT interval corrected for heart rate using Bazett's formula QTcB >= 480 msec
167
Predose mean QTc? 450 msec or QTcF ? 450 msec.
168
Mean QTcF interval > 450 msec at screening.
169
Subjects have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
170
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
171
Mean resting corrected QT interval (QTc using Fridericia’s formula [QTcF]) > 470 msec
172
QTcF > 470 msec on Screening ECG (mean of triplicate recordings).
173
QTcF > 470 msec on the screening ECG
174
Have Fridericia-corrected QT interval (QTcF) >480 milliseconds on screening electrocardiogram (ECG).
175
Congenital long QT syndrome or QT interval corrected using Fridericia's formula (QTcF) >470 milliseconds (msec)
176
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)
177
A baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec, a complete left bundle branch block (defined as a QRS interval ? 120 msec in left bundle branch block form) or an incomplete left bundle branch block.
178
Subject with a QTcF of > 450 msec in male subjects and > 470 msec in female subjects on the screening 12 lead ECG.
179
Patients with baseline QTcF ? 480 msec
180
Corrected QT interval using Fridericia's formula (QTcF) interval equal to or less than 470 msec
181
QTcF ? 450 msec for males or 470 msec for females.
182
Screening and Baseline QTcF (Fridericia's) less than 470 msec
183
Patient has clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
184
Patients who have, at screening, corrected QT interval using Fridericia's formula (QTcF) >= 450 msec for males and QTcF >= 470 for females
185
A QT interval corrected for heart rate using the Bazett's formula (QTcB) >=480 millisecond (msec);
186
QTcF interval on electrocardiogram (ECG) at screening > 450 msec for males or > 460 for females;
187
Prolonged QTcF
188
The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes.
189
Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTcF-interval over 450 msec
190
QT interval measurement corrected by Fridericia's formula (QTcF) interval of >450 msec (males) or >470 msec (females)
191
Cardiovascular baseline corrected QT by Fridericia's (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study
192
A corrected QT interval >=480 msec (e.g. Bazett's formula [QTcB])
193
QTcF interval > 450 msec (males) or > 470 msec (females)
194
Serious cardiac condition such as myocardial infarction within the past 6 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 12-lead ECG with Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 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
195
Current long QT syndrome or baseline prolongation of QT/QTcF interval, i.e. demonstration of a QTcF interval > 450 msec
196
Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the Electrocardiogram (ECG) > 470 msec.
197
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.
198
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
199
Pretreatment QTcF interval >470 msec (females) or >450 msec (males)
200
A baseline ECG QTcF > 470 msec
201
At Screening, QTcF >450 msec for males; QTcF >470 msec for females
202
QTcF interval < 450 msec and mean resting heart rate 50-90 bpm
203
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
204
Subject has electrocardiogram (ECG) showing clinically significant abnormality at screening or an average QTc interval (Fridercia's or Bazett's formula) >450 msec in males and >470 msec in females (>480 msec for subjects with Bundle Branch Block (BBB)).
205
Friderichia corrected QT interval (QTcF) >450 milliseconds (msec) (men) or >475 msec (women) on a 12-lead electrocardiogram (ECG) during the Screening period.
206
Prolongation of QTcF interval to >480 milliseconds (msec)
207
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.
208
Fridericia's Heart Rate Correction Formula (QTcF) interval >450 msec;
209
QT interval corrected using Fridericia's formula (QTcF) >450 milliseconds
210
Fridericia's correction formula (QTcF) =< 470 msec
211
Patients with a QT interval corrected by Fridericia's formula (QTcF) > 450 msec (QTcF > 480 msec for patients with bundle branch block)
212
Prolongation of the corrected QT interval by Fridericia's formula (QTcF) interval defined as > 450 msec for males and > 470 msec for females
213
Impaired cardiac function including any one of the following: complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (< 50 beats per minute), QT interval corrected by Fridericia's formula (QTcF) > 450 msec on screening electrocardiogram (ECG), or right bundle branch block + left anterior hemiblock (bifascicular block)
214
Subject has QTcF interval > 450 msec (average of triplicate determinations based on central reading).
215
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.
216
Fridericia corrected QT interval (QTcF) >450 milliseconds (msec) (men) or >475 msec (women) on a 12-lead electrocardiogram (ECG) during the Screening period.