Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial.
Margaret C Bell, Patricia R Robuck, Elizabeth C Wright, Marina S Mihova, Charlotte Hofmann, Jennifer L De Santo, Susan L Milstein, Pamela A Richtmyer, Janel L Shelton, Maureen Cormier and 5 more
Article in Clinical trials (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what money
Authors and funding
15 authors.
Margaret C BellNew England Research Institutes, Watertown, MA 02472, USA. mbell@neriscience.com
Patricia R Robuck
Elizabeth C Wright
Marina S Mihova
Charlotte Hofmann
Jennifer L De Santo
Susan L Milstein
Pamela A Richtmyer
Janel L Shelton
Maureen Cormier
Debra L King
Choon J Park
Wallis A Molchen
Yoon Park
Michelle Kelley
Funding
ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ZAIA, JOHN A · 1985 to 2010
$76.4M
ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CHANG, R JEFFREY · 1985 to 2010
$74.3M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KOSMISKI, LISA A. · 1985 to 2008
$52.6M
ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI RUBENFIRE, MELVYN · 1985 to 2007
$40.8M
ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI BROWN, EMERY N · 1985 to 2008
$37.4M
X-LINKED HYPOPHOSPHATEMIAM01RR000065 · NCRR · VIRGINIA COMMONWEALTH UNIVERSITY · PI SANYAL, ARUN J · 1985 to 2010
$24.8M
ZONISAMIDE VERSUS PLACEBOM01RR006192 · NCRR · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI DRAZINIC, CAROLYN M · 1994 to 2008
$22.1M
XU 40468 IN HYPERCHOLESTEROLEMIAM01RR000633 · NCRR · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 1985 to 2007
$21.0M
HEPATITIS C CLINICAL TRIAL-DATA COORDINATING CENTER-267092328N01DK092328 · NIDDK · NEW ENGLAND RESEARCH INSTITUTES, INC. · 1999 to 2004
$1.5M
Novel Approaches to Alcoholism Pharmacotherapy and RiskK24AA013736 · NIAAA · UNIVERSITY OF PENNSYLVANIA · PI KRANZLER, HENRY RICHARD · 2002 to 2012
$1.5M
HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERSN01DK092326 · NIDDK · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI BONKOVSKY, HERBERT L · 1999 to 2000
$872k
HEPATITIS C CLINICAL TRIAL- CLINICAL CENTERSN01DK092322 · NIDDK · VIRGINIA COMMONWEALTH UNIVERSITY · PI SHIFFMAN, MITCHELL L · 1999 to 2000
backgroundEven though adverse event (AE) collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines specifying how to summarize the event for reporting in a timely and expeditious manner. This article details the AE and serious adverse event (SAE) reporting summary developed for a large multi-center National Institutes of Health (NIH)-sponsored clinical trial. PURPOSE: To review and analyze the large volume of AE data reported by 10 sites (806 SAEs and 19,034 AEs from August 2000 to May 2007) the automated SAE summary was developed. It was designed to ensure timeliness and clarity in the complex process of AE review and reporting.
methodsThe AE and SAE case report forms (CRFs) as well as the automated SAE summary were developed within a database management system developed by the Data Coordinating Center (DCC) which allowed for web-based data entry at the DCC and 10 sites and offered immediate overall and site-specific reports accessible by the DCC, site, and NIH project staff.
resultsThe automated SAE summary pulled data from multiple CRFs to create a succinct and informative summary and allowed for prompt and easy reporting to the regulatory agencies. The summary was adaptable to the needs of reviewers because of the availability of multiple search options.
Indexed as
Adverse Drug Reaction Reporting SystemsAntiviral AgentsCarcinoma, HepatocellularDatabase Management SystemsDisease ProgressionElectronic Data ProcessingHepatitis C, ChronicHumansInterferon-alphaInterferon alpha-2Liver CirrhosisLiver FailureLiver NeoplasmsMulticenter Studies as TopicNational Institutes of Health (U.S.)Polyethylene GlycolsAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant Proteins
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.
Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial. · full record | OpenQuestion