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Selgantolimod (GS-9688)

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Signature Requirement Guidance

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Sofosbuvir/Velapatasvir (Epclusa)

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Study Physician Attestation and Agreement for Electronic Signatures

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.

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Study Statuses

Study statuses and milestones handout.

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Sutezolid (PNU-100480)

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Tamoxifen Citrate Package Insert

Tamoxifen Citrate Tablets USP, a nonsteroidal antiestrogen, are for oral administration.

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TBI-223

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Tecovirimat (TPOXX)

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Tenofovir Disoproxil Fumarate (Viread) Package Insert

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…

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Tenofovir Disoproxil Fumarate (Viread) Risk List

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

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Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir

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Tenofovir Enema Formulation

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TMC207 (Bedaquiline)

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Translation Confirmation Document

DAIDS protocol registration translation confirmation document.

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Trimethoprim/Sulfamethoxazole (Septra) Package Insert

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…

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Uganda - DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

Presentation from webinar on using the Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0.

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Uganda - Expedited Reporting to DAIDS and DAERS Refresher June 2014

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

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Uganda - Expedited Reporting to DAIDS and DAERS Refresher November 2014

.zip file contains: Presentation slides from November 2014 webinar training on adverse events Study handout accompanying training Presentation about expedited reporting on Adverse Events Presentation about reporting via DAERS Case study on Adverse Events Case Study on chest pain

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V3G CH848 Pr-NP1, Adjuvanted and V3G CH848 mRNA-Tr2

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Vesatolimod (GS-9620)

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Vincristine Sulfate Injection Package Insert

Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin’s disease, non–Hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms’ tumor.

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VIR-1778

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Vorinostat (Zolinza)

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Vorinostat (Zolinza) Package Insert

ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies

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