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ABT-267, ABT 333, ABT-450 and Ritonavir

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Accessing and Maintaining Site Personnel Information in the DAIDS-ES

Tutorial guide, with screenshots, for the DAIDS-ES system.

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ACTG - Expedited Reporting to DAIDS and DAERS Refresher

Presentation on expedited reporting to DAIDS plus a case study on expedited reporting via DAERS.

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Addendum 1, Female Genital Grading Table for Use in Microbicide Studies

Guidance table for grading the severity of adult and pediatric adverse events with female genital involvement during microbicide studies.

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Addendum 2 Male Genital Grading Table for Use in Microbicide Studies

Guidance table for grading the severity of adult and pediatric adverse events with male genital involvement during microbicide studies.

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Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012)

Guidance table for grading the severity of adult and pediatric adverse events with rectal involvement during microbicide studies.

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Bedaquiline (Sirturo) Package Insert

SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (18 years and older) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO by…

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Bleomycin for Injection, Package Insert

Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.

Bleomycin Sulfate Package Insert

Temporary importation of Bleomycin Sulfate Powder for Injection, 15,000 International Units (IU) to address drug shortage issue

Combivir (lamivudine and zidovudine) Tablets, Package Insert

COMBIVIR, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 

Completion Instructions for the DAIDS EAE Form

Line by line instructions for how to complete the Expedited Adverse Events reporting form.

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DAERS Access User Guide for EAE Reporter and Submitter Rights

Term definitions and access rights for Reporters and Submitters using DAERS.

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DAERS Reference Guide for Site Enrollment Users

Technical guide to the DAERS system for Site Enrollment users.

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DAERS Reference Guide for Site Reporters and Study Physicians

Detailed manual on the DAERS system for Site Reporters and Study Physicians.

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DAERS Site User Instructional Guide for EAE Reporting

Formatted specifically for printing. applicable, to special instructions to keep in mind while entering values.

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DAIDS Safety Information Types

Definitions of the types of safety information distributed by DAIDS and methods of distribution.

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DAIDS Safety Workshop Durban SA (Nov 2015)

Training workshop in Durban, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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DAIDS Safety Workshop Johannesburg SA (Nov 2015)

Training workshop in Johannesburg, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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Dapivirine (Microbicide Gel)

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Dapivirine (Vaginal Ring)

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Dapivirine-Levonorgestrel (Vaginal Ring)

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Darunavir (Prezista) Risk List

The following serious side effects have been associated with the use of darunavir given together with ritonavir (RTV). Contact your healthcare provider if you have any of the symptoms of liver problems that are listed and any skin changes with the symptoms listed below.

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Delamanid (OPC-67683)

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Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events - Changes Highlighted

Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. Changes are highlighted visually within the document.

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Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Changes Highlighted Corrected Version 2.1, July 2017

Instructions for using the Table for Grading the Severity of Adult and Pediatric Adverse Events. Changes highlighted, Corrected version 2.1, July 2017

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