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The following serious side effects have been associated with the use of nevirapine: Severe liver damage that can result in death may occur and is often associated with a rash. Being female or having a higher CD4 cell count, regardless of gender, increases the risk of developing liver damage.

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VIRAMUNE is an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older.

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Completed Non-IND studies that have met or exceeded the 3 year retention period (per 45 CFR 46.115); CRFs and pharmacy records will not be stored by DAIDS.

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Therapeutic Indications: Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with (cisplatin or carboplatin)In…


This DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected version 2.1, July 2017 supersedes version 2.1 of the table dated March 2017. Changes to note in this corrected version 2.1 of the Severity Grading Table are parameter specific and are highlighted below in…

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The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 contains a number of parameter level (i.e., adverse event) severity grading criteria changes detailed below when compared with the Division of AIDS Table for Grading the S everity of Adult…

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The Division of AIDS Table for grading the severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) is a collection of commonly encountered adverse events and their descriptive terminology utilized for severity grading. As part of its standard review processes, DAIDS reassessed the “…

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PegIntron is an antiviral indicated for treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease. (1.1)

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LIVALO is a HMG-CoA reductase inhibitor indicated for: Patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase…

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PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more anti-tuberculosis (anti-TB) drugs to which the isolate is susceptible. (1.1) *…

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Protocol Development Lifecycle flowchart

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Quick reference card for protocol registration at a glance.

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Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).

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Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).

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Use this to make sure you don't miss any required pieces of information when recording and reporting an adverse event.

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One-sheet references for writing a narrative case summary of an adverse event and for evaluation and follow-up.

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