Solicited Adverse Events
If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours. If "yes" is ticked, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.
text
Solicited Adverse Events Record - Local Symptoms
Applies to every single local symptom and should be filled out for each one. If a symptom is ticked, all items hereafter shold be filled out
boolean
Local Symptom
text
To be filled out for each day
integer
Intensity: 0 / 1 / 2 / 3, if pain is ticked if pain occurred INTENSITY FOR NON-SOLICITED SYMPTOMS 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy).
integer
Size in mm, if redness, swelling or ecchymosis occurred
integer
Ongoing Symptom
boolean
if ongoing after Day 6
date
Solicited Adverse Events - General Symptoms
Solicited Adverse Events Record - General Symptoms
Applies to every single local symptom and should be filled out for each one. If a symptom is ticked, all items hereafter shold be filled out
boolean
arthralgia = joint pain
text
To be filled out for each day
integer
Intensity: 0 / 1 / 2 / 3 INTENSITY FOR NON-SOLICITED SYMPTOMS 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy).
integer
Ongoing Symptom
boolean
Date of Last Day of Symptoms
date
Causality
boolean
Solicited Adverse Events - Fever
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
boolean
If fever occurred oral is preferred
text
To be filled out for each day
integer
Body Temperature
float
Temperature not Taken
boolean
Ongoing Symptom
boolean
Date of Last Day of Symptoms
date
Causality
boolean
Unsolicited Adverse Events