Concomitant medications
Item
Concomitant medications
text
Adverse Events
Item
Adverse Events
text
Physical Examination
Item
Physical Examination
text
Date of Assessment
Item
Date of Assessment
date
Cardiovascular
Item
Cardiovascular
boolean
Abdomen (Liver and Spleen)
Item
Abdomen (Liver and Spleen)
boolean
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
CL Item
[A 1] Sinus bradycardia (1)
CL Item
[A21] Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
[A22] Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
[A23] Sinus bradycardia (heart rate < 30 beats/min) (4)
CL Item
[A 3] Sinus pause (5)
CL Item
[A 2] Sinus tachycardia (6)
CL Item
[A 4] Ectropic supraventricular beats (7)
CL Item
[A20] Ectropic supraventricular rythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate > 100 beats/min) (10)
CL Item
[A 6] Supraventricular tachycardia (Heart rate > 100 beats/min) (11)
CL Item
[A 7] Atrial flutter (12)
CL Item
[A 8] Atrial fibrillation (13)
CL Item
[A 5] Junctional rhythm (heart rate <100 beats/min) (14)
CL Item
[A25] Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 beats/min) (16)
CL Item
[A 9] Ectopic ventricular beats (17)
Item
P-Wave and QRS Morphology
integer
Code List
P-Wave and QRS Morphology
CL Item
[B 3] right ventricular hypertrophy (1)
CL Item
[B 5] Intraatrial conduction delay (2)
CL Item
[B 7] Poor R wave progression (3)
CL Item
[B 9] Left atrial abnormality (4)
CL Item
[B10] Right atrial abnormality (5)
CL Item
[A12] Ventricular couplets (6)
CL Item
[A13] Bigeminy (7)
CL Item
[A28] Trigeminy (8)
CL Item
[A14] Electrical alternans (9)
CL Item
[A29] R on T phenomenon (10)
CL Item
[A18] Ventricular vebrilation (11)
CL Item
[A19] Indioventricular rhythm (heart rate < 100 bpm) (12)
CL Item
[A10] Sustained ventricular tachycardia (13)
CL Item
[A11] Non-sustained ventricular tachycardia (14)
CL Item
[A33] Sinus arrhythmia (15)
CL Item
[A33] Sinus arrhythmia (15)
CL Item
[A27] Ventricular tachycardia (16)
CL Item
[A30] Monomorphic ventricular tachycardia (17)
CL Item
[A15] Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (18)
CL Item
[A31] Polymorphic (sustained and non-sustained) ventricular tachycardia (19)
CL Item
[A16] Artificial pacemaker (20)
CL Item
[A35] Atrial premature complex (21)
CL Item
[A99]Other abnormal rhythm (22)
CL Item
[B16] Late R wave transition (23)
CL Item
[D14] Increased voltage consistent with left ventricular hypertrophy (24)
CL Item
[B99] Other morphology (25)
CL Item
[C 1] First degree AV block (PR interval > 200 msec) (1)
CL Item
[C20] Short PR interval (2)
CL Item
[C 2] Second degree AV block (Mobitz type 1) (3)
CL Item
[C 3] Second degree AV block (Mobitz type 2) (4)
CL Item
[C16] 2:1 AV block (5)
CL Item
[C 4] Third degree AV block (6)
CL Item
[C 5] Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
[C 6] Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
[C 7] Incomplete right bundle branch block (9)
CL Item
[C13] Incomplete left bundle branch block (10)
CL Item
[C 8] Right bundle branch block (11)
CL Item
[C 14] Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
Item
Myocardial Infraction
integer
Code List
Myocardial Infraction
CL Item
[D 1] Myocardial infraction, old (1)
CL Item
[D 2] Myocardial infraction, anterior (2)
CL Item
[D 3] Myocardial infraction, lateral (3)
CL Item
[D 4] Myocardial infraction, posterior (4)
CL Item
[D 5] Myocardial infraction, inferior (5)
Item
Depolarisation/Repolarisation (QRS-T)
integer
Code List
Depolarisation/Repolarisation (QRS-T)
CL Item
[D 7] Non-specific ST-T changes (1)
CL Item
[D19] J point elevation (2)
CL Item
[D 8] ST elevation (3)
CL Item
[D21] ST elevation-pericarditis (4)
CL Item
[D 9] ST depression (5)
CL Item
[D96] ST segment abnormality, not specified (6)
CL Item
[D10] U waves abnormal (7)
CL Item
[D11] T wave inversion (8)
CL Item
[D12] T wave peaked (9)
Item
Other abnormalities
integer
Code List
Other abnormalities
CL Item
[E99] Other abnormalities (1)
CL Item
[C15] Left posterior hemiblock (synonymous to left posterior fascicular block) (2)
CL Item
[C 9] Left bundle branch block (3)
CL Item
[C17] Bifascicular block (4)
CL Item
[C10] Non-specific intraventricular conduction delay (QRS>120msec) (5)
CL Item
[C11] Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (6)
CL Item
[C18] AV dissociation (7)
CL Item
[C28] Prolonged QT 450-500 (8)
CL Item
[C29] Prolonged QT >500 (9)
CL Item
[C30] Prolonged QTc Interval 450-500 (10)
CL Item
[C31] Prolonged QTc Interval >500 (11)
CL Item
[C99] Other conduction (12)
CL Item
[D 6] Myocardial infraction, septal (13)
CL Item
[D20] Myocardial infraction, Non-Q wave (14)
CL Item
[D08] Other myocardial infraction (15)
CL Item
[D15] T waves flat (16)
CL Item
[D16] T waves biphasic (17)
CL Item
[D18] Notched T-waves (18)
CL Item
[D13] Low QRS voltage (19)
CL Item
[D17] T-wave flattening/inversion (20)
CL Item
[D22] Juvenile T wave pattern, early repolarization (21)
CL Item
[D97] T wave abnormality, not specified (22)
CL Item
[D99] Other depolarization/repolarization (23)
Consent for PGx Research
Item
Consent for PGx Research
text
Has consent been obtained for PGx Research?
Item
Has consent been obtained for PGx Research?
boolean
If YES, record the date informed consent obtained for PGx Research
Item
If YES, record the date informed consent obtained for PGx Research
date
Item
If NO, choose ONE reason:
text
Code List
If NO, choose ONE reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify_______________ (3)
Sample collection
Item
Sample collection
text
Has a Sample been collected for PGx Research?
Item
Has a Sample been collected for PGx Research?
boolean
If YES, record a date sample taken
Item
If YES, record a date sample taken
date
Withdrawal of consent
Item
Withdrawal of consent
boolean
If YES, record the date informed consentwithdrawn for PGx research
Item
If YES, record the date informed consentwithdrawn for PGx research
date
Sample destruction
Item
Sample destruction
boolean
Item
If YES, choose one reason:
text
Code List
If YES, choose one reason:
CL Item
[1] Subject requested (1)
CL Item
[z] Other, specify_____________ (2)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
if YES, record each medication on a separate line using Trade Names where possible
Item
if YES, record each medication on a separate line using Trade Names where possible
text
Drug name
Item
Drug name
integer
Unit dose
Item
Unit dose
integer
Frequency
Item
Frequency
integer
Reason for Medication
Item
Reason for Medication
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Taken prior to Study?
Item
Taken prior to Study?
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Ongoing Medication
Item
Ongoing Medication
boolean
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Outcome
Item
Outcome
integer
End Date
Item
End Date
date
End Time
Item
End Time
time
Frequency
Item
Frequency
integer
Maximum Intensity
Item
Maximum Intensity
integer
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
Item
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
Did the subject experience a SAE during the study?
Item
Did the subject experience a SAE during the study?
boolean
SECTION 1
Item
SECTION 1
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Outcome
Item
Outcome
integer
End Date
Item
End Date
date
End Time
Item
End Time
time
Maximum Intensity
Item
Maximum Intensity
integer
Action taken with Investigational Product(s) as a result of the SAE
Item
Action taken with Investigational Product(s) as a result of the SAE
integer
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
if FATAL, was a post-mortem/autopsy performed
Item
if FATAL, was a post-mortem/autopsy performed
boolean
SECTION 2
Item
SECTION 2
text
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify______________________________ (6)
CL Item
Liver injury and impaired liver function (7)
SECTION 3 Demography Data
Item
SECTION 3 Demography Data
text
Date of Birth
Item
Date of Birth
date
SECTION 4
Item
SECTION 4
text
Item
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
Code List
If investigational product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
SECTION 5 Possible causes of SAE other than Investigational Product(s)
text
Code List
SECTION 5 Possible causes of SAE other than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify______________________ (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify________________ (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify ________________________________ (7)
SECTION 6 RELEVANT Medical Conditions
Item
SECTION 6 RELEVANT Medical Conditions
text
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
Item
Specify any RELEVANT past or present medical disorders, allergies, surgeries that can help explain the SAE.
text
Date of onset
Item
Date of onset
date
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
If NO, Date of Last Occurrence
Item
If NO, Date of Last Occurrence
date
SECTION 7 Other relevant risk factors
Item
SECTION 7 Other relevant risk factors
text
SECTION 8 RELEVANT concomitant medications
Item
SECTION 8 RELEVANT concomitant medications
text
Drug Name
Item
Drug Name
text
Frequency
Item
Frequency
float
Taken prior to study?
Item
Taken prior to study?
boolean
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing Medication?
Item
Ongoing Medication?
boolean
Reason for Medication
Item
Reason for Medication
text
SECTION 9 Details of Investigational Product(s)
Item
SECTION 9 Details of Investigational Product(s)
text
SECTION 10 Details of RELEVANT assessments
Item
SECTION 10 Details of RELEVANT assessments
text
SECTION 11 Narrative Remarks
Item
SECTION 11 Narrative Remarks
text
Investigator's signature
Item
Investigator's signature
text
Investigator's name (print)
Item
Investigator's name (print)
text