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KALETRA is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older).

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This manual applies to all DAIDS-supported and/or -sponsored clinical trials, unless the DAIDS Office for Policy in Clinical Research Operations (OPCRO) Director or designee has delegated the responsibility for expedited adverse event (EAE) reporting to another entity (e.g., a pharmaceutical or…

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

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Depo-Provera CI is a progestin indicated only for the prevention of pregnancy.

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The rectal grading table was initiated by a group of researchers who developed and used it. They subsequently discovered items that needed revision through use in several protocols. The revisions have been approved by DAIDS. A summary of the changes include the following and have been incorporated…

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DAIDS has developed clarifications for the "DAIDS AE Grading Table" in order to address questions and comments received from site investigators, Operations Offices, Statistical and Data Management Centers, and Medical Officers within the Division. The subsequent clarifications have been outlined in…

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Contains training materials from MTN annual meeting including presenation slides and case study. Meeting was held in March 2016.

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MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white…

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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…

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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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