Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2: Difference between revisions
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| | |has_document=Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 | ||
| | |module=5 | ||
| | |unit=5.2.4 | ||
| | |scope=G | ||
| | |doc_part=5.3.2 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00252-Exp-hle | |||
|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00252-Exp-hle|Expedited reporting]] | |||
|comment=Recurrent adverse events: definition and handling | |||
|content=5.3.2 Recurrent AEs | |||
| | |||
| | |||
= | |||
5.3.2 Recurrent AEs | |||
A recurrent AE is one that occurs and resolves during a cycle/course of therapy and then reoccurs in a later cycle/course. | A recurrent AE is one that occurs and resolves during a cycle/course of therapy and then reoccurs in a later cycle/course. | ||
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2) Hospitalization or prolongation of hospitalization (≥24 hours) at any time is associated with the recurring SAE, even if the grade does not increase. | 2) Hospitalization or prolongation of hospitalization (≥24 hours) at any time is associated with the recurring SAE, even if the grade does not increase. | ||
[...] | [...] | ||
}} | |||
Revision as of 12:56, 16 July 2026
| Document information | |
|---|---|
| Reference | USA NCI GUIDELINES FOR INVESTIGATORS:
ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| Validity area | USA |
| Scope(s) | G |
| Document name | NCI GUIDELINES FOR INVESTIGATORS:
ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs |
| Version / Revision | 30-Aug-2024 |
| Status | Current |
| Document type | Other |
| Language(s) | EN |
| Description | National Cancer Institute
GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.2.4 |
| Scope | G |
| Document part | 5.3.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Adverse event, Definition, Expedited reporting |
Content
5.3.2 Recurrent AEs
A recurrent AE is one that occurs and resolves during a cycle/course of therapy and then reoccurs in a later cycle/course. Instructions for ROUTINE reporting: An AE that resolves and then recurs during a subsequent cycle/course must be reported in each cycle on which it occurs. Instructions for EXPEDITED reporting: An AE that resolves and then recurs during a subsequent cycle/course does not require CTEP-AERS reporting unless: 1) The grade increases OR 2) Hospitalization or prolongation of hospitalization (≥24 hours) at any time is associated with the recurring SAE, even if the grade does not increase. [...]
