Serious adverse events
Type of report
integer
SAE occurrence
text
Diagnosis Only (if known) Otherwise Sign/Symptom
text
day month year
date
If you tick "Recovered/Resolved"or "Recovered/Resolved with sequelae", provide End Date and Time in the following items. If you tick "Fatal", record Date of Death in the following item.
integer
day month year
date
00:00-23:59
time
Maximum Intensity
text
Action Taken with Investigational Product(s) as a Result of the AE
text
Withdrawal as result of SAE
text
Relationship between SAE and investigational product
text
Relationship between SAE to study participation
text
Seriousness
Results in death
boolean
Life-threatening
boolean
Requires hospitalisation or prolongation of existing hospitalisation
boolean
Results in disability/incapacity
boolean
Congenital anomaly/birth defect
boolean
Other reason
boolean
Other reason, specification
text
Relevant Concomitant/treatment medications
(Trade Name preferred)
text
Dose of medication
float
Unit of dosage
text
Frequency of medication
text
Route of medication
text
day month year
date
If you tick No, please specify the End Date in the following item.
text
day month year
date
Primary Indication
text
Drug Type
text
Relevant medical conditions/Risk factors
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
text
day month year
date
If you tick No, please specify the date of last occurrence in the following item.
text
day month year
date
Relevant diagnostic results
Test Name
text
day month year
date
Test Result
text
Test Units
text
Normal Low Range
float
Normal High Range
float
Relevant diagnostic results not noted above
text
Investigational Products
Recurrence of event after investigational product administration
text
General Narrative Comments
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
text