Eligibility Criteria

Inclusion and exclusion criteria
Descripción

Inclusion and exclusion criteria

*Inclusion criteria for Cases:* Cases were defined as those subjects ≥18 years of age at the time of an incident of drug-induced LQTS and/or TdP who had one of the following:
Descripción

*Inclusion criteria for Cases:* Cases were defined as those subjects ≥18 years of age at the time of an incident of drug-induced LQTS and/or TdP who had one of the following:

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0001779
UMLS CUI [1,4]
C0023976
UMLS CUI [1,5]
C0040479
An uncorrected QT interval ≥600 msec while on drug that decreased to <480 msec following withdrawal of drug;
Descripción

An uncorrected QT interval ≥600 msec while on drug that decreased to <480 msec following withdrawal of drug;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0577807
UMLS CUI [1,4]
C0743284
A change in uncorrected QT interval of at least 100 msec (either from the pre-exposure to the during-exposure ECG or from the during-exposure to the post-exposure ECG) with an uncorrected QT interval >480 msec while on drug; or
Descripción

A change in uncorrected QT interval of at least 100 msec (either from the pre-exposure to the during-exposure ECG or from the during-exposure to the post-exposure ECG) with an uncorrected QT interval >480 msec while on drug; or

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0577807
UMLS CUI [1,4]
C0743284
An episode of ECG-documented TdP with a subsequent ECG with no evidence of TdP following withdrawal of drug.
Descripción

An episode of ECG-documented TdP with a subsequent ECG with no evidence of TdP following withdrawal of drug.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0743284
UMLS CUI [1,4]
C1623258
UMLS CUI [1,5]
C0040479
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C1706256
UMLS CUI [2,3]
C1395815
UMLS CUI [2,4]
C1623258
UMLS CUI [2,5]
C1298908
UMLS CUI [2,6]
C0040479
*Exclusion criteria for Cases:*
Descripción

*Exclusion criteria for Cases:*

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
Potassium level ≤3 mmol at onset of event (1 mEq = 1 mmol);
Descripción

Potassium level ≤3 mmol at onset of event (1 mEq = 1 mmol);

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0302353
Subarachnoid hemorrhage at onset of event;
Descripción

Subarachnoid hemorrhage at onset of event;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0038525
UMLS CUI [1,4]
C0574845
Cardiac bypass <24 hours before onset of event;
Descripción

Cardiac bypass <24 hours before onset of event;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0010055
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0574845
Hospital admission diagnosis of hypothermia at time of event;
Descripción

Hospital admission diagnosis of hypothermia at time of event;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0184666
UMLS CUI [1,4]
C0020672
UMLS CUI [1,5]
C4759356
Diagnosed with congenital LQTS prior to onset of event;
Descripción

Diagnosed with congenital LQTS prior to onset of event;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C1141890
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0332162
UMLS CUI [1,6]
C0441471
Currently leukopenic (WBC<1000 cells/mL);
Descripción

Currently leukopenic (WBC<1000 cells/mL);

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C0023530
Has had a non-autologous bone marrow transplant at anytime in the past
Descripción

Has had a non-autologous bone marrow transplant at anytime in the past

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706256
UMLS CUI [1,3]
C4039784
*Inclusion criteria for Control Group A:*
Descripción

*Inclusion criteria for Control Group A:*

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
18 years of age or older;
Descripción

18 years of age or older;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0001779
New start on QT-prolonging antiarrhythmic drug(s); and
Descripción

New start on QT-prolonging antiarrhythmic drug(s); and

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0151878
UMLS CUI [1,4]
C0003195
Hasn't received a blood transfusion in the past 4 months
Descripción

Hasn't received a blood transfusion in the past 4 months

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C1298908
UMLS CUI [1,4]
C0005841
*Inclusion criteria for Control Group B:*
Descripción

*Inclusion criteria for Control Group B:*

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
Healthy subjects between the ages of 18 and 40;
Descripción

Healthy subjects between the ages of 18 and 40;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0001779
Not on any regular medication;
Descripción

Not on any regular medication;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C1298908
UMLS CUI [1,4]
C0455633
Non-smoker; and
Descripción

Non-smoker; and

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0337672
Normal ECG
Descripción

Normal ECG

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0522054

Similar models

Eligibility Criteria

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion and exclusion criteria
*Inclusion criteria for Cases:* Cases were defined as those subjects ≥18 years of age at the time of an incident of drug-induced LQTS and/or TdP who had one of the following:
Item
*Inclusion criteria for Cases:* Cases were defined as those subjects ≥18 years of age at the time of an incident of drug-induced LQTS and/or TdP who had one of the following:
boolean
C1512693 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0023976 (UMLS CUI [1,4])
C0040479 (UMLS CUI [1,5])
An uncorrected QT interval ≥600 msec while on drug that decreased to <480 msec following withdrawal of drug;
Item
An uncorrected QT interval ≥600 msec while on drug that decreased to <480 msec following withdrawal of drug;
boolean
C1512693 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0577807 (UMLS CUI [1,3])
C0743284 (UMLS CUI [1,4])
A change in uncorrected QT interval of at least 100 msec (either from the pre-exposure to the during-exposure ECG or from the during-exposure to the post-exposure ECG) with an uncorrected QT interval >480 msec while on drug; or
Item
A change in uncorrected QT interval of at least 100 msec (either from the pre-exposure to the during-exposure ECG or from the during-exposure to the post-exposure ECG) with an uncorrected QT interval >480 msec while on drug; or
boolean
C1512693 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0577807 (UMLS CUI [1,3])
C0743284 (UMLS CUI [1,4])
An episode of ECG-documented TdP with a subsequent ECG with no evidence of TdP following withdrawal of drug.
Item
An episode of ECG-documented TdP with a subsequent ECG with no evidence of TdP following withdrawal of drug.
boolean
C1512693 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0743284 (UMLS CUI [1,3])
C1623258 (UMLS CUI [1,4])
C0040479 (UMLS CUI [1,5])
C1512693 (UMLS CUI [2,1])
C1706256 (UMLS CUI [2,2])
C1395815 (UMLS CUI [2,3])
C1623258 (UMLS CUI [2,4])
C1298908 (UMLS CUI [2,5])
C0040479 (UMLS CUI [2,6])
*Exclusion criteria for Cases:*
Item
*Exclusion criteria for Cases:*
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
Potassium level ≤3 mmol at onset of event (1 mEq = 1 mmol);
Item
Potassium level ≤3 mmol at onset of event (1 mEq = 1 mmol);
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0302353 (UMLS CUI [1,3])
Subarachnoid hemorrhage at onset of event;
Item
Subarachnoid hemorrhage at onset of event;
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0038525 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])
Cardiac bypass <24 hours before onset of event;
Item
Cardiac bypass <24 hours before onset of event;
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0574845 (UMLS CUI [1,5])
Hospital admission diagnosis of hypothermia at time of event;
Item
Hospital admission diagnosis of hypothermia at time of event;
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
C0020672 (UMLS CUI [1,4])
C4759356 (UMLS CUI [1,5])
Diagnosed with congenital LQTS prior to onset of event;
Item
Diagnosed with congenital LQTS prior to onset of event;
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C1141890 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0332162 (UMLS CUI [1,5])
C0441471 (UMLS CUI [1,6])
Currently leukopenic (WBC<1000 cells/mL);
Item
Currently leukopenic (WBC<1000 cells/mL);
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C0023530 (UMLS CUI [1,3])
Has had a non-autologous bone marrow transplant at anytime in the past
Item
Has had a non-autologous bone marrow transplant at anytime in the past
boolean
C0680251 (UMLS CUI [1,1])
C1706256 (UMLS CUI [1,2])
C4039784 (UMLS CUI [1,3])
*Inclusion criteria for Control Group A:*
Item
*Inclusion criteria for Control Group A:*
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
18 years of age or older;
Item
18 years of age or older;
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
New start on QT-prolonging antiarrhythmic drug(s); and
Item
New start on QT-prolonging antiarrhythmic drug(s); and
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0003195 (UMLS CUI [1,4])
Hasn't received a blood transfusion in the past 4 months
Item
Hasn't received a blood transfusion in the past 4 months
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0005841 (UMLS CUI [1,4])
*Inclusion criteria for Control Group B:*
Item
*Inclusion criteria for Control Group B:*
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Healthy subjects between the ages of 18 and 40;
Item
Healthy subjects between the ages of 18 and 40;
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
Not on any regular medication;
Item
Not on any regular medication;
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0455633 (UMLS CUI [1,4])
Non-smoker; and
Item
Non-smoker; and
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0337672 (UMLS CUI [1,3])
Normal ECG
Item
Normal ECG
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0522054 (UMLS CUI [1,3])