Type of Report
Randomisation
Serious adverse event Entry
Hidden
text
SAE Diagnosis or Sign/Symptom
text
Hidden
text
Hidden
text
Hidden
text
Hidden
boolean
Adverse Event Start Date/Time
partialDatetime
if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death
integer
if applicable
partialDatetime
Serious Adverse Event Frequency
integer
[hidden]
text
SAE Maximum Grade
integer
[hidden]
text
Action regarding Investigational Product
text
Subject withdrawal because of AE
text
AE possibly caused by investigational product
text
[hidden]
time
[hidden]
time
SAE caused by activities related to study participation
text
[hidden]
text
Seriousness
Adverse Event Results in death
boolean
Adverse event is life-threatening
boolean
adverse event requires hospitalisation or prolongation of hospitalisation
boolean
Serious adverse event results in disability/incapacity
boolean
Serious adverse event: Congenital anomaly/birth defect
boolean
specify within general narrative comment
boolean
Liver injury and impaired liver function by ALT, Total bilirubin, INR
boolean
Relevant concomitant/treatment medications Entry
[hidden]
text
(Trade Name preferred)
text
Concomitant medication dose
float
Concomitant medication unit
text
Concomitant medication frequency
text
Concomitant medication route
text
Concomitant Medication Start Date
partialDate
if no, specify End Date
text
Concomitant medication end date
partialDate
Concomitant Medication Primary Indication
text
Drug Type
text
Relevant Medical Conditions/Risk Factors
[hidden]
text
Specific Condition
text
Date of onset
partialDate
If no, specify date of last occurrence
text
Date of last disease occurence
partialDate
Relevant Other Medical History / Risk Factors
text
Relevant Diagnostic Results
[hidden]
text
Lab Test Name
text
Test Date
partialDate
Laboratory Test Result
text
Laboratory Test Units
text
Normal Low Range
text
Normal High Range
text
Relevant other diagnostic laboratory results
text
Investigational Product
Event recurrence after investigational product administered again
text
General narrative comments
Non clinical
[hidden]
boolean
[hidden]
datetime
[hidden]
text
[hidden]
text
[hidden]
text
[hidden]
text
[hidden]
text
[hidden]
text
[hidden]
text