Adverse event: Difference between revisions
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== Background == |
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* 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 |
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* Does not necessarily have a causal relationship with the treatment |
* Does not necessarily have a causal relationship with the treatment |
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* A '''serious adverse event''' is also known as a [[Adverse drug reaction|serious adverse drug reaction]] |
* A '''serious adverse event''' is also known as a [[Adverse drug reaction|serious adverse drug reaction]] |
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== Grading == |
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=== Common Terminology Criteria for Adverse Events (CTCAE) === |
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!Grade |
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!Description |
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|Grade 1 |
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|Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated |
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|Grade 2 |
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|Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living. |
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|Grade 3 |
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|Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL |
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|Grade 4 |
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|Life-threatening consequences; urgent intervention indicated |
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|Grade 5 |
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|Death related to AE |
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[[Category:Research]] |
[[Category:Research]] |
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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 |
