Adverse Events
User ID of reviewing physician populated by system.
text
Verbatim AE
text
Term sent for MedDRA coding
text
AE - MedDRA Code
text
Serious AE
text
SAE
integer
AE - Start Date
date
AE - Start time
time
AE - Continuing
boolean
AE - Stop Date
date
AE - Stop time
time
AE - Number of episodes
integer
AE - Intensity
text
AE - Action
text
AE - Therapy
text
AE - Outcome
integer
AE - Experience Course
text
AE - Intensity (maximum)
text
AE - Action with respect to Investigational Drug
text
AE - Total Number episodes
integer
AE - Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
boolean
AE - Corrective Therapy
text
Was patient withdrawn due to this AE?
text
Serious Adverse Events
SAE - Collected
text
Enter all that apply
integer
2. Did the SAE abate
boolean
3. If study medication was interrupted, stopped, or dose reduced: Was study medication reintroduced
boolean
3. If study medication was reintroduced, did SAE recur?
boolean
4. If Relationship to Investigational drug was NOT RELATED or UNLIKELY choose an assessment. The SAE is probably associated with
integer
5. Please provide details supporting the selection made in item 4
text
Please provide a brief narrative description of the SAE
text
Was the randomization code broken at the investigational site
text
Randomization/study medication
text
Form activated if SAE_Reason = Fatal
date
Form activated if SAE_Reason = Fatal
text
Form activated if SAE_Reason = Fatal
boolean
Dorm activated if SAE_Reason = Fatal
text
SAE Report signed by:
text
Demography
Demography - Date
date
Demography - Time
time
Demography - Day
text
Demography - Hour
integer
Demography - Min
integer
Date of Birth
date
Sex
text
Race
integer
Race Other
integer
Subject Type
text
Group of Patient when SUBTYPE = Patient (Normal entered where SUBTYPE = volunteer)
text
Height Weight
Height Weight - Physical Date
date
Height Weight - Time
time
Height Weight - Day
text
Height Weight - Hour
integer
Height Weight - Min
integer
Height
integer
Weight
float
ECG
ECG Date
date
ECG Time
time
ECG Day
text
ECG Hour
integer
ECG Min
integer
ECG Normal
text
Ventricular Rate
integer
PR Interval
integer
QRS Interval
integer
QT Interval
integer
QTc Interval
integer
ECG Interpretation
text
ECG Interpretation
text
ECG Holter
ECG Holter Day
text
ECG Holter Hour
integer
ECG Holter Min
integer
ECG Recording Start Date
date
ECG Holter Start time
time
ECG Recording Stop Date
date
ECG Holter Stop Time
time
ECG Holter - Type of Monitoring
integer
ECG Holter Normal
text
ECG Holter - Analysis Details
text