- NLM Digital Collections - Targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis : ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, August 3, 2018... 8 adverse events, serious adverse events, or Baseline characteristics adverse events leading for partial responders at to treatment wk ...
- NLM Digital Collections - Long term follow-up after administration of human gene therapy productsPublication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020... exposures to other agents with potential for delayed adverse events. Hence, characteristics of the patient population and the disease to ... appropriate to detect potential gene therapy-related delayed adverse events ... be due to the characteristics of the product, the nature of the exposure ( ...
- NLM Digital Collections - Medical devices : cancer risk led FDA to warn against certain uses of power morcellators and ....Publication: Washington, D.C. : U.S. Government Accountability Office, February 2017... receiving their predicates, while 6 had new technological characteristics. adverse event reports, and the actions FDA has taken in ... Comments 30 Appendix I Food and Drug Administration’s ... 36 Appendix III General Characteristics of the 25 510(k) Submissions for Laparoscopic ...
- ... Hosp Mark 1990;4(2): 13-31 Hospital characteristics associated with adverse events and substandard care. Brennan TA, et al. JAMA ... Med 1991 Apr;84(4):213-6 Hospital characteristics associated with adverse events HOSPITAL LITERATURE INDEX, VOLUME 47, 1991 271 HOSPITALS, ...
- NLM Digital Collections - Analysis of supply, distribution, demand, and access issues associated with immune globulin ...Publication: Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, 2007... products could standardize the products given and reduce adverse events. 3.6. CHARACTERISTICS OF RECENT DEMAND LEVELS AND DEMAND GROWTH 3. ...
- NLM Digital Collections - Poly ADP-ribose polymerase (PARP) inhibitors for ovarian cancer : effectiveness and value : ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, September 28, 2017... Adverse Event Frequency in Study 19 and SOLO2 Adverse Events Frequency Study 1924 SOLO225 Characteristic, n (%) Olaparib Placebo (n=129) Olaparib (n=195) Placebo (n=99) (n=136) Any Adverse Event 130 (95.6) 116 (90.6) 192 (98. ...
- NLM Digital Collections - REMS : FDA's application of statutory factors in determining when a REMS is necessaryPublication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2019... and reliability of available scientific evidence about the adverse events as well as the characteristics of the risks, including the reversibility, preventability, temporality, ...
- NLM Digital Collections - Human gene therapy for hemophiliaPublication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020... up for adverse events. We recommend: • Monitoring for adverse events should consider: 1) several product characteristics (e.g., integrating vector, nonintegrating vector, genome editing) ...
- NLM Digital Collections - M4E(R2) : the CTD--efficacyPublication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017... the intended dose • Mechanism of action for the adverse event, if known, including nonclinical information or class effects • Completeness of information on patient characteristics (e.g., smoking history, concomitant medication use) that ...
- NLM Digital Collections - Cognitive and mind-body therapies for chronic low back and neck pain : effectiveness and ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, November 6, 2017... Scale (score 0-8), and preferences and expectations. Adverse events were collected throughout the study. Overall baseline characteristics were balanced among the arms with a mean ...
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