№ files_lp_4_process_3_130193
File format: docx
Character count: 2010
File size: 22 KB
Reference table describing the frequency and types of common, occasional, and rare adverse reactions reported in patients receiving osimertinib within oncology treatment and clinical trial contexts.
Medication:
Osimertinib
Table Version Date:
December 5, 2025
Subject:
Adverse effects of cancer therapy
Document Type:
Side effect reference table
Field:
Oncology
Related Clinical Context:
Clinical trials involving standard cancer therapies
Organization Mentioned:
National Cancer Institute (NCI)
Program:
Cancer Therapy Evaluation Program (CTEP)
Review Body Mentioned:
NCI Central Institutional Review Board (CIRB)
Country:
United States
Intended Users:
Research staff
Associated Platform:
Clinical Trials Support Unit (CTSU) protocol pages
Purpose:
Reference information on potential adverse reactions during treatment
Content Structure:
Common, occasional, and rare side effects with approximate frequency ranges
Regulatory Note:
Not approved by NCI CIRB as a patient information sheet unless reviewed by the IRB of record
Price: 8 / 10 USD
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Year:
2024
Region / city:
Australia
Topic:
Oncology, Pharmaceutical Submission
Document Type:
Submission for Pharmaceutical Listing
Organ / institution:
Therapeutic Goods Administration (TGA)
Author:
Unknown
Target Audience:
Medical Practitioners, Regulatory Authorities
Period of Validity:
N/A
Approval Date:
November 28, 2024
Date of Last Revision:
N/A
Year:
2024
Region / City:
Australia
Topic:
Pharmaceutical Submission, Oncology
Document Type:
Submission for Pharmaceutical Benefits Scheme (PBS) Listing
Organ / Institution:
Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target Audience:
Healthcare Professionals, Medical Practitioners
Period of Effectiveness:
Ongoing (starting 30 October 2024)
Approval Date:
30 October 2024
Date of Changes:
2 December 2024
Clinical Criteria:
First-line treatment, Locally advanced or metastatic NSCLC, EGFR mutations
Indication:
Locally advanced (Stage IIIB/C) or metastatic (Stage IV) EGFRm non-small cell lung cancer
Drug Formulation:
Osimertinib combined with cisplatin or carboplatin and pemetrexed
Treatment Phase:
Initial treatment (first-line)
Comparator:
Osimertinib monotherapy
Outcome Measures:
PFS, OS, ORR, DoR, DCR
Background:
TGA approval for osimertinib combination therapy for EGFRm NSCLC
Preliminary PBAC Consideration:
Not previously considered for this indication
Requested Listing:
Authority Required Pharmaceutical Benefits Scheme listing
Context:
A pharmaceutical submission for the listing of osimertinib in combination with platinum-based chemotherapy and pemetrexed for first-line treatment of EGFR-mutated non-small cell lung cancer in Australia.
Year:
2021
Region / city:
Australia
Topic:
Oncology / Pharmaceutical
Document Type:
Submission
Agency:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
AstraZeneca Pty Ltd
Target Audience:
Medical professionals, regulatory authorities
Validity Period:
2021-2026
Approval Date:
20 April 2021
Modification Date:
Not specified
Year:
2023
Region / City:
Australia
Topic:
Oncology, Pharmaceutical Submission
Document Type:
Pharmaceutical Resubmission
Organization:
AstraZeneca Pty Ltd
Author:
Not specified
Target Audience:
Medical Practitioners
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A pharmaceutical resubmission document outlining the use of osimertinib as a first-line treatment for locally advanced or metastatic EGFRm non-small cell lung cancer (NSCLC) in Australia, including previous PBAC considerations and clinical trial data.
Year:
2026
Region / city:
UK
Subject:
Electric Vehicle Charge Points, Heat Pumps, and connection procedures
Document Type:
Application form
Organization / institution:
Distribution Network Operators (DNOs)
Author:
Not specified
Target audience:
Individuals or entities installing electric vehicle charge points (EVCP) or heat pumps (HP)
Effective Period:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
N/A
Region / City:
N/A
Theme:
Foster Care, Kinship Care, Child Welfare
Document Type:
Form
Agency / Institution:
N/A
Author:
N/A
Target Audience:
Agency Representatives, Foster Parents, Kinship Parents, Social Workers
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Contextual Description:
A form used for documenting and assessing the well-being and progress of children in various care placements, such as foster, therapeutic foster, or residential care.
Year:
2019
Region / city:
Geneva
Subject:
Madrid System for International Registration of Marks
Document type:
Working Group Report
Organization:
International Bureau
Author:
International Bureau
Target audience:
Member States and relevant stakeholders of the Madrid System
Period of validity:
Not specified
Date of approval:
May 21, 2019
Date of changes:
Not specified
Note:
Contextual description
Year:
2023
Region / City:
Forth Valley
Topic:
Incident Reporting, Controlled Drugs
Document Type:
Report Form
Organization / Institution:
NHS Forth Valley
Author:
Kirsty Peacock, Scott Mitchell
Target Audience:
NHS staff, Contractors
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not provided
Region / City:
Not provided
Theme:
Research methodology
Document type:
Academic paper
Organization:
AGH University of Science and Technology Press
Author:
Not specified
Target audience:
Researchers, academics, students
Period of validity:
Not specified
Approval date:
Not provided
Date of amendments:
Not provided
Year:
2024
Region / city:
USA
Topic:
Medical, Oncology
Document Type:
Educational Materials
Organization:
NCI CIRB
Author:
NCI
Target Audience:
Research staff, IRB members, clinical trial participants
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
United States
Topic:
Medicine, Side Effects, Clinical Trials
Document Type:
Educational Material
Organization:
NCI CIRB
Author:
N/A
Target Audience:
Research Staff, Clinical Trial Staff
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2024
Region / city:
USA
Topic:
Medical Information, Cancer Treatment
Document Type:
Educational Resource
Author:
National Cancer Institute (NCI)
Target Audience:
Research staff, Clinical trial participants, Healthcare professionals
Action Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2022
Region / City:
US
Topic:
Medical, Pharmacology
Document Type:
Research Resource
Organization / Institution:
National Cancer Institute (NCI)
Author:
Not specified
Target Audience:
Research staff, clinical trial personnel
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2024
Region / city:
USA
Theme:
Medical / Oncology
Document type:
Side Effect Table
Organization:
NCI CIRB
Target Audience:
Research staff, Clinical trial participants
Period of validity:
N/A
Approval date:
N/A
Modification date:
N/A
Year:
2023
Region / City:
United States
Topic:
Side effects of chemotherapy
Document type:
Educational Material
Organization / Institution:
National Cancer Institute (NCI)
Author:
Not specified
Target audience:
Research staff, clinical trial participants
Effective period:
Not specified
Approval date:
Not specified
Date of revisions:
Not specified
Year:
2025
Region / city:
United States
Topic:
Side effects of cancer therapy
Document type:
Patient Educational Material
Author:
National Cancer Institute
Target audience:
Research staff, clinical trial participants
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2025
Region / city:
US
Theme:
Cancer Treatment, Side Effects
Document Type:
Medical Resource
Organization:
National Cancer Institute (NCI)
Author:
Not specified
Target Audience:
Research Staff, Medical Professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
November 13, 2025
Year:
2023
Region / City:
United States
Topic:
Oncology, Pharmacology
Document Type:
Medical Information
Author:
NCI CIRB
Target Audience:
Clinical Research Staff
Period of Validity:
Indefinite
Approval Date:
Not Approved
Date of Changes:
March 22, 2023