Adverse event: Difference between revisions
From IDWiki
(Created page with "* Any untoward medical occurrence in a patient or research participant who is receiving a treatment * Does not necessarily have a causal relationship with the treatment Category:Research") |
No edit summary |
||
| (2 intermediate revisions by the same user not shown) | |||
| Line 1: | Line 1: | ||
== Background == |
|||
* Any untoward medical occurrence in a patient or research participant who is receiving a treatment |
* Any untoward medical occurrence in a patient or research participant who is receiving a treatment |
||
* Does not necessarily have a causal relationship with the treatment |
* Does not necessarily have a causal relationship with the treatment |
||
* Adverse events that have at least a possible relationship with the treatment are called [[Adverse drug reaction|adverse reactions]] |
|||
* A '''serious adverse event''' is also known as a [[Adverse drug reaction|serious adverse drug reaction]] |
|||
== Grading == |
|||
=== Common Terminology Criteria for Adverse Events (CTCAE) === |
|||
{| class="wikitable" |
|||
!Grade |
|||
!Description |
|||
|- |
|||
|Grade 1 |
|||
|Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated |
|||
|- |
|||
|Grade 2 |
|||
|Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living. |
|||
|- |
|||
|Grade 3 |
|||
|Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL |
|||
|- |
|||
|Grade 4 |
|||
|Life-threatening consequences; urgent intervention indicated |
|||
|- |
|||
|Grade 5 |
|||
|Death related to AE |
|||
|} |
|||
[[Category:Research]] |
[[Category:Research]] |
||
Latest revision as of 13:33, 23 July 2024
Background
- Any untoward medical occurrence in a patient or research participant who is receiving a treatment
- Does not necessarily have a causal relationship with the treatment
- Adverse events that have at least a possible relationship with the treatment are called adverse reactions
- A serious adverse event is also known as a serious adverse drug reaction
Grading
Common Terminology Criteria for Adverse Events (CTCAE)
| Grade | Description |
|---|---|
| Grade 1 | Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated |
| Grade 2 | Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living. |
| Grade 3 | Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL |
| Grade 4 | Life-threatening consequences; urgent intervention indicated |
| Grade 5 | Death related to AE |
