Wednesday, June 23, 2010
What is a Serious Adverse Event?
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported when the patient outcome is:
Death
Report if the patient's death is suspected as being a direct outcome of the adverse event.
Life-Threatening
Report if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient's death.
Examples: Pacemaker failure; gastrointestinal hemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free flow resulting in excessive drug dosing.
Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of a hospital stay results because of the adverse event.
Examples: Anaphylaxis; pseudomembranous colitis; or bleeding causing or prolonging hospitalization.
Disability
Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity; peripheral neuropathy.
Congenital Anomaly
Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.
Examples: Vaginal cancer in female offspring from diethylstilbestrol during pregnancy; malformation in the offspring caused by thalidomide.
Requires Intervention to Prevent Permanent Impairment or Damage
Report if you suspect that the use of a medical product may result in a condition which required medical or surgical intervention to preclude permanent impairment or damage to a patient.
Examples: Acetaminophen overdose-induced hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage; burns from radiation equipment requiring drug therapy; breakage of a screw requiring replacement of hardware to prevent malunion of a fractured long bone.
FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals
FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals
New website will contain safety reports on recently approved drugs, biologics
Prime Oncology Clinical Spotlight: Chicago/Dr's Monk/Birrer - GOG128
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prIME Oncology invites you to view important Clinical SpotlightsSM on new ovarian cancer data just released from the 2010 Oncology Annual Meeting in Chicago.
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View an expert analysis with Gini Fleming, MD, and Bradley Monk, MD, and a supplemental perspective and discussion with Bradley Monk, MD, and Michael Birrer, MD, PhD,
regarding newly released data concerning targeting angiogenesis in the
treatment of ovarian cancer as reported in the GOG-0218 trial.
An eNewsflash and downloadable slide deck highlighting these new data accompany these interviews.
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Click here to view the interviews, eNewsflash, and downloadable slide deck
from this data release.Immunohistochemical profile of steroid cell tumor of the ovary: a study of 14 cases and a review of the literature (pathology)
"Immunohistochemistry helps in the distinction between SCTs of the ovary and other primary or metastatic ovarian neoplasms with eosinophilic and clear-cell histology. In addition, immunohistochemistry can confirm the presence of recurrent SCT, if no sufficient clinical history is provided. As some SCTs can be positive for epithelial markers and histologically similar epithelial tumors can be positive for sex cord stromal markers, the use of multiple immunohistochemical stains is recommended."
Fox Run makes debut at parade - Paul Benivegna (Carolyn) in the news
"...Did that create a chain reaction! Fox Run’s Paul Benivegna, a Korean War veteran who chairs the community’s hobby shop, got to work designing a veterans-themed float..." cont'd
Abstract/full free access: Adherence to cancer screening guidelines across Canadian provinces: an observational study
Note:
1) study period - "We calculated age-cancer-specific screening rates for ages 40-60 using the Canadian Community Health Survey (2003 and 2005), a cross-sectional, nationally representative survey of health status, health care utilization and health determinants in the Canadian population."
2) includes: breast, mammography, PSA
website: Canadian Community for Dialogue and Deliberation
Note: includes section on employment offerings
Genetic Variation in TYMS in the One-Carbon Transfer Pathway Is Associated with Ovarian Carcinoma Types in the Ovarian Cancer Association Consortium — Cancer Epidemiology, Biomarkers & Prevention
Note: abstract onlyOR = overall risk; 1.0+ denotes an increased risk;
in this study, mucinous cell type was the key finding
Methods:Associations were evaluated in the Ovarian Cancer Association Consortium, including 16 studies of 5,593 epithelial ovarian carcinoma cases and 9,962 controls of white non-Hispanic origin.
Results: The five polymorphisms were not associated with ovarian carcinoma overall ; however, associations for the minor allele at TYMS rs495139 were observed for carcinomas of mucinous type (OR, 1.19; 95% CI, 1.03-1.39; P = 0.02), clear cell type (OR, 0.86; 95% CI, 0.75-0.99; P = 0.04), and endometrioid type (OR, 0.90; 95% CI, 0.81-0.99; P = 0.04; Pheterogeneity = 0.001). Restriction to low-grade mucinous carcinomas further strengthened the association for the mucinous type (OR, 1.32; 95% CI, 1.07-1.62; P = 0.01). TYMS rs495139 was not associated with serous type (OR, 1.06; 95% CI, 1.00-1.13; P = 0.05).
Conclusions: TYMS rs495139 may be associated with a differential risk of ovarian carcinoma types, indicating the importance of accurate histopathologic classification.
Impact: Biomarkers that distinguish ovarian carcinoma types are few, and TYMS rs495139 may provide a novel clue to type etiology.
Cancer Epidemiol Biomarkers Prev; 19(7); 1822–30. ©2010 AACR.
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