重篤有害事象、重大副作用

WordNet

used as an intensive especially to indicate something unexpected; "even an idiot knows that"; "declined even to consider the idea"; "I dont have even a dollar!"
become even or more even; "even out the surface" (同)even out
make even or more even (同)even out
equal in degree or extent or amount; or equally matched or balanced; "even amounts of butter and sugar"; "on even terms"; "it was a fifty-fifty (or even) split"; "had a fifty-fifty (or even) chance"; "an even fight" (同)fifty-fifty
occurring at fixed intervals; "a regular beat"; "the even rhythm of his breathing" (同)regular
symmetrically arranged; "even features"; "regular features"; "a regular polygon" (同)regular
to a greater degree or extent; used with comparisons; "looked sick and felt even worse"; "an even (or still) more interesting problem"; "still another problem must be solved"; "a yet sadder tale" (同)yet, still
being level or straight or regular and without variation as e.g. in shape or texture; or being in the same plane or at the same height as something else (i.e. even with); "an even application of varnish"; "an even floor"; "the road was not very even"; "the picture is even with the window"
divisible by two
in spite of; notwithstanding; "even when he is sick, he works"; "even with his head start she caught up with him"
to the full extent; "loyal even unto death"
requiring effort or concentration; complex and not easy to answer or solve; "raised serious objections to the proposal"; "the plan has a serious flaw"
concerned with work or important matters rather than play or trivialities; "a serious student of history"; "a serious attempt to learn to ski"; "gave me a serious look"; "a serious young man"; "are you serious or joking?"; "Dont be so serious!"
of great consequence; "marriage is a serious matter"
a special set of circumstances; "in that event, the first possibility is excluded"; "it may rain in which case the picnic will be canceled" (同)case
a phenomenon located at a single point in space-time; the fundamental observational entity in relativity theory
something that happens at a given place and time
contrary to your interests or welfare; "adverse circumstances"; "made a place for themselves under the most untoward conditions" (同)inauspicious, untoward
in an opposing direction; "adverse currents"; "a contrary wind" (同)contrary
the latter part of the day (the period of decreasing daylight from late afternoon until nightfall); "he enjoyed the evening light across the lake" (同)eve, even, eventide
a later concluding time period; "it was the evening of the Roman Empire"
the early part of night (from dinner until bedtime) spent in a special way; "an evening at the opera"

PrepTutorEJDIC

『平らな』,平たんな / 『同じ高さの』,同一平面の,平行の / (運動・動作・品質などが)『均一の』,規則的な,一様の,むらのない / (数・量などが)『同じの』,等しい,釣り合のとれた互角の / 『偶数の』 / 公平な,公正な(fair) / 平静な,穏やかな,落ち着いた(calm) / 貸借にない,清算済みの / 端数のない,ちょうどの,きっかりの / 《意味を強めて,不審や意外の念を含み》…『でさえも』,までも / 《比較級の前に用いて》『なおいっそう』,さらに(still,yet) / 《形容詞の前または後の用いて》(…と)すら言える;《古》《時を表す副詞の前に用いて》ちょうど / …‘を'平らにする,ならす / …‘を'釣り合わせる,平均させる《+『up』+『名』,+『名』+『up』》 / …‘の'変動をなくする,‘を'安定させる《+『out』+『名』,+『名』+『out』》
夕べ,晩
『まじめな』,厳粛な / 『本気の』,冗談でない,真剣の / (物事が)『重大な』,容易ならない / (人・作品などが)重要な,偉い
(特に重要な)『でき事』,事件;行事 / (スポーツの)『種目』;勝負,試合 / 《文》成り行き,結果
反対の,逆の / 逆方向の
『夕方』,夕刻,晩(日没から就寝時までの間) / 《文》末期,晩年 / 夜会,夕べ / 夕方の,夕暮れの

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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/05/13 13:06:37」(JST)

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[Wiki en表示]

A serious adverse event (SAE) in human drug trials are defined as any untoward medical occurrence that at any dose

results in death,
is life-threatening
requires inpatient hospitalization or causes prolongation of existing hospitalization
results in persistent or significant disability/incapacity,
is a congenital anomaly/birth defect, or
requires intervention to prevent permanent impairment or damage.^[1]

The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.^[2] Adverse events are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”^[2]

Research

Investigators in human clinical trials are obligated to report these events in clinical study reports.^[3] Research suggests that these events are often inadequately reported in publicly available reports.^[4] Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit.^[5] To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.^[6]

Related Terms

Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form). "Unexpected" means that for an authorised (approved) medicinal product that the event is not described in the product's labeling, or in the case of an investigational (unapproved) product that the event is not listed in the Investigator’s Brochure.

An adverse effect is an adverse event which is believed to be caused by a health intervention.

Footnotes

^ http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm
^ ^a ^b Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (August 25, 2007). "Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting." (PDF). FDA Center for Drug Evaluation and Research.
^ Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. (August 25, 2007). "Guideline for Industry Structure and Content of Clinical Study Reports." (PDF). FDA Center for Drug Evaluation and Research.
^ Ioannidis JP, Lau J. (2001). "Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.". JAMA 285 (4): 437–43. doi:10.1001/jama.285.4.437. PMID 11242428.
^ Chou R, Helfand M. (2005). "Challenges in systematic reviews that assess treatment harms.". Ann Intern Med 142 (12 Pt 2): 1090–0. PMID 15968034.
^ Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D; CONSORT Group. (2004). "Better reporting of harms in randomized trials: an extension of the CONSORT statement.". Ann Intern Med 141 (10): 781–8. PMID 15545678.

External links

What Is A Serious Adverse Event? (MedWatch)
ClinicalTrials.gov from US National Library of Medicine
ICH Website

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English Journal

Safety and efficacy of recombinant activated factor VII in nonhemophilia children with severe or life-threatening bleeding: a report from the SeveNBleeP registry.

Blatný J1, Mathew P, Monagle P, Ovesna P, Fiamoli V.
Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.Blood Coagul Fibrinolysis.2014 Jun;25(4):326-32. doi: 10.1097/MBC.0000000000000036.
We evaluated efficacy and safety of recombinant activated factor VII (rFVIIa) in nonhemophilia children with life-threatening or severe bleeding. Using data from the SeveNBleeP registry, we analyzed demographic, clinical, laboratory, and treatment data for children who received rFVIIa to treat sever
PMID 24389586

Linagliptin treatment in subjects with type 2 diabetes with and without mild-to-moderate renal impairment.

Groop PH1, Del Prato S, Taskinen MR, Owens DR, Gong Y, Crowe S, Patel S, von Eynatten M, Woerle HJ.
Diabetes, obesity & metabolism.Diabetes Obes Metab.2014 Jun;16(6):560-8. doi: 10.1111/dom.12281. Epub 2014 Mar 24.
AIMS: Renal disease is a frequent comorbidity of type 2 diabetes mellitus (T2DM) and an important factor complicating the choice of glucose-lowering drugs. The aim of this analysis was to evaluate the efficacy and safety of the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin (5 mg/day) in mono,
PMID 24612167

A double-blind, randomized comparison study of efficacy and safety of intramuscular olanzapine and intramuscular haloperidol in patients with schizophrenia and acute agitated behavior.

Chan HY1, Ree SC, Su LW, Chen JJ, Chou SY, Chen CK, Chen YS.
Journal of clinical psychopharmacology.J Clin Psychopharmacol.2014 Jun;34(3):355-8. doi: 10.1097/JCP.0000000000000120.
Studies of intramuscular (IM) olanzapine in Asian and Taiwanese populations are limited. This study examined the efficacy and safety of IM olanzapine in Taiwanese patients with schizophrenia and acute agitated behavior.This was a multicenter, double-blind, randomized, parallel study comparing the ef
PMID 24743717

Japanese Journal

Safety and efficacy of fluticasone furoate nasal spray in Japanese children 2 to <15 years of age with perennial allergic rhinitis: A multicentre, open-label trial

, , ,
Allergology International 64(1), 60-65, 2015
… As a safety measure, adverse events and clinical laboratory data were evaluated.Results: An adverse event was reported by 67% of patients during the treatment and follow-up period, all of which were mild in intensity. … The most commonly reported adverse events were nasopharyngitis and acute sinusitis (acute rhinosinusitis). … There were no serious adverse events. …
NAID 130004873122

Onset of puberty and near adult height in short children born small for gestational age and treated with GH: Interim analysis of up to 10 years of treatment in Japan

, , , , , , ,
Clinical Pediatric Endocrinology 24(1), 15-25, 2015
… Treatment-related adverse events were generally mild to moderate in severity; … however, adenoidal hypertrophy was observed in two subjects as a serious adverse event. …
NAID 130004853604