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The following side effects have been associated with the use of abacavir:

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

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

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

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

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

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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 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.


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


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. 


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

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

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Technical guide to the DAERS system for Site Enrollment users.

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

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

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

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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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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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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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