Non-Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event Specification
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
text
C1518404 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Start Date
Item
Start Date Record the start date of the first occurence of the AE. (Day Month Year) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
date
C0808070 (UMLS CUI [1])
Item
Outcome All AEs must be followed until the events are resolved, the conditin stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Recovered/Resolved" or "Recovered/Resolved with sequelae". If AE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not recovered/Not resolved" or "Recovering/Resolving". Also enter "Not recovered/Not resolved" if the AE was ongoing at the time of death, but was not the cause of death. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
integer
C1705586 (UMLS CUI [1])
Code List
Outcome All AEs must be followed until the events are resolved, the conditin stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Recovered/Resolved" or "Recovered/Resolved with sequelae". If AE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not recovered/Not resolved" or "Recovering/Resolving". Also enter "Not recovered/Not resolved" if the AE was ongoing at the time of death, but was not the cause of death. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date Record the end date. This is the date the AE Recoverd/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject's medical condition resolved or stabilised. Leave blank if the AE is "Not recovered/Not resolved" or "Recovering/Resolving". Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity Record the maximum intensity that occured over the duration of the event. Amend the intensity if it increases. Mild= An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everday activities. Moderate= An event that is sufficiently discomforting to interfere with normal everday activities. Severe= An event that prevents normal everyday activities. Not applicable= those event(s) where intensity is meaningless or impossible to determine (i.e. blindness and coma) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum Intensity Record the maximum intensity that occured over the duration of the event. Amend the intensity if it increases. Mild= An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everday activities. Moderate= An event that is sufficiently discomforting to interfere with normal everday activities. Severe= An event that prevents normal everyday activities. Not applicable= those event(s) where intensity is meaningless or impossible to determine (i.e. blindness and coma) Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occured. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or post-dosing). Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
integer
C1704758 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occured. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or post-dosing). Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
CL Item
Investigational product(s) (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Withdrawal
Item
Withdrawal Indicate "Yes" if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate "No". Did the subject withdraw from study as a result of this AE? Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
boolean
C2349954 (UMLS CUI [1])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) it is a regulatory requirement for investigators to assess relationship to investigatinal product(s) based on information available. The asessment should be reviewed on receipt of any new information and amended if necessary. "A reasonable possibility" is meant to convey that there are facts/evidence of arguments to suggest a causal relationship. Facts/evidence or arguments that may support "a reasonable possibility" include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant, a concurrent illness, or relevant medical history, should also be considered. Is there a reasonable possibility that the AE may have been caused by the investigational product? Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
