Sage-Tips

What does resolved with sequelae mean?

SAEs will be followed until resolution (until the subject’s health has returned to his/her baseline status or all variables have returned to normal). For “Recovered/Resolved with sequelae,” indicate the sequelae (for example, if the event is “stroke” the sequelae may be “numbness in left arm”).

When is a serious adverse event considered resolved?

Select the final status of the patient when the adverse event is considered “resolved”. 1- Recovered – the event (CTCAE term + grade) has resolved to normal or changed to a lower or higher grade. The recovery may be due to the suspension of study treatment or due to concomitant treatments that have ended.

What is reconciliation in pharmacovigilance?

SAE data reconciliation It is an iterative process that occurs several times during the study. The objective is to reconcile all discrepancies before final clinical database lock in order to submit validated data to regulatory authorities.

What is indication narrative in case of PV?

Narrative writing is an important part of Pharmacovigilance and in patient safety as well. A narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial/treatment.

What does sequelae mean in medical terms?

1 : an aftereffect of a disease, condition, or injury. 2 : a secondary result.

Is sequelae singular or plural?

From Wikipedia, the free encyclopedia. A sequela (UK: /sɪˈkwiːlə/, US: /sɪˈkwɛlə/; usually used in the plural, sequelae /-iː/) is a pathological condition resulting from a disease, injury, therapy, or other trauma.

What should happen after an adverse event?

After an adverse event, Five A’s: Acknowledgment, Apology, All the Facts, Assurance and Appropriate Compensation, serve to meet the essential needs of patients and their families.

When is a patient’s narrative completed?

Patient narrative is a summary of AEs occurring in a clinical trial patient/subject. It is generally written for the following criteria: Death, serious AE (SAE), event(s) of special interest, AE leading to study drug/trial discontinuation, and adjudication event(s).

What are aggregate reports?

Aggregate Reports refers to those reports that focus not so much on individual cases, but rather on overview, assessment of the safety profile and benefit-risk-evaluation. They comprise e.g. or safety related parts of Clinical Study Reports.

What does it mean for an event to resolve with sequelae?

So an event resolving with sequelae means that the events resolve, but its resolution leaves a symptom or a condition behind. Classic example is, memory loss or dementia or disorientation following head injury

What is a sequela in psychology?

A sequela ( UK: / sɪˈkwiːlə /, US: / sɪˈkwɛlə /; usually used in the plural, sequelae) is a pathological condition resulting from a disease, injury, therapy, or other trauma. Typically, a sequela is a chronic condition that is a complication which follows a more acute condition.

What is causality in pharmacovigilance?

In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event. Is there a convincing relationship between the drug and the event? Did the drug actually cause the event?

What does resolved mean in medical terms?

Resolved: the event is fully resolved or stabilized; return to baseline condition for chronic disorders. Resolved with sequelae: the event is resolved, but patient has some permanent condition as a consequence of the event (e.g. mild paraesthesia following transient ischaemic attack).