The following serious side effects have been associated with the use of rilpivirine: Depression or mood changes. Be sure to contact your health care provider immediately if you are feeling sad or hopeless, feeling anxious or restless, or have thoughts of hurting yourself (suicide) or have tried to…
NORVIR is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
.zip file contains: Case review on adverse events Safety training presentations on adverse events, expedited reporting and assessment, Expedited reporting via DAERS a safety training case study handout Training given in the Republic of South Africa in October 2016.
SELZENTRY is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg.
This form is to document that the signator of this document is authorized to use the DAIDS-ES system, and understands that their electronic signature (eSignature) is used to electronically sign database records.
Study statuses and milestones handout.
Tamoxifen Citrate Tablets USP, a nonsteroidal antiestrogen, are for oral administration.
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1) VIREAD is indicated…
The following side effects have been associated with the use of tenofovir:
DAIDS protocol registration translation confirmation document.
SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product. Each SEPTRA Tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.4 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium…
Presentation from webinar on using the Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0.
Zip file contains: Presentation slides from ACTG June 2014 network meeting Presentation to ACTG about expedited reporting on Adverse Events Presentation to ACTG about reporting via DAERS Case study on Adverse Events Case Study on chest pain