Serious ADE definition

Serious ADE is defined as any Adverse Drug Experience occurring at any dose that results in any of the following outcomes: death, a Life-Threatening Adverse Drug Experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant Disability/incapacity, or a congenital anomaly/birth defect. Other important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a Serious Adverse Drug Experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Serious ADE has the meaning set forth in 21 CFR §314.80(A), as amended from time to time.
Serious ADE means an adverse event which gives rise to one or more of the following: death, threat to life, new or prolonged in-patient hospitalization, permanent or significant disability or incapacitation, overdose, cancer or congenital abnormality or serious laboratory abnormality which is thought by the reporting physician to be serious or associated with relevant clinical signs or symptoms. Genpharm shall, or shall cause the applicable Manufacturer to, notify Resources in the manner and within the time periods hereinbefore contemplated of any ADE or FDA complaint (or of the complaint of any governmental body, agency or official in the Territory) relating to such Product in respect of the Territory following their receipt by Genpharm or such Manufacturer.

Examples of Serious ADE in a sentence

  • Anticipated Serious Adverse Device Effect (ASADE) Serious ADE which by its nature, incidence, severity or outcome has been identified in the risk management file.

  • Examples of in situ approaches are fluorescence in situ hybridization (FISH) and mRNA in situ hybridization (ISH).

  • Serious ADE bordering on life-threatening Serious ADE Captopril 6.25 mg PO TID.

  • Major DAA combination selected: DSV+OTP/PTV/r±RBV: 60.3%, SOF/LDV±RBV: 24.1% Serious ADE (grade 3/4): DSV+OTP/PTV/r±RBV: 22 patients (7.3%): hyperbilirubinemia (9), fatigue (3), confusion (2), itching (2), anemia (2), vomiting, diarrhea, sleep disorders, dyspnea; SOF/LDV±RBV: 10 patients (8,3%): hyperbilirubinemia (3), fatigue (3), headache, diarrhea, muscle pain, dry skin; SOF+DCV±RBV: 6 patients (20,7%): hyperbilirubinemia (5), sleep disorders; SOF+SMV±RBV: 5 patients (13.9%): hyperbilirubinemia (5).

  • If an AE or SAE is determined to have been the result of a PEX-CIS assay abnormality (e.g., false positive, false negative, measurement error), it will be deemed an ADE or a Serious ADE (SADE) for the purpose of device reporting and statistical analysis.

Related to Serious ADE

  • Serious harm means harm, whether physical or nonphysical, including psychological, economic, or reputational, to an individual which would compel a reasonable individual of the same background and in the same circumstances to perform or continue to perform labor or services or sexual activity to avoid incurring the harm.

  • Serious assault means an act that constitutes a felony violation of chapter XI of the Michigan penal code, 1931 PA 328, MCL 750.81 to 750.90h, or that constitutes an assault and infliction of serious or aggravated injury under section 81a of the Michigan penal code, 1931 PA 328, MCL 750.81a.

  • Serious Adverse Event means any adverse event that led to any of the following:

  • Serious health condition means an illness, injury, impairment, or physical or mental condition that involves:

  • Serious crime means conduct constituting an offence punishable by a maximum deprivation of liberty of at least four years or a more serious penalty;

  • Serious violation means a violation of this act, an order issued pursuant to this act, or a rule or standard promulgated under this act or adopted by reference pursuant to this act for which a substantial probability exists that death or serious physical harm could result from the violation or from a practice, means, method, operation, or process that is in use, unless the employer did not and could not, with the exercise of reasonable diligence, know of the presence of the violation.

  • serious criminal offence means an offence which corresponds or is equivalent to one of the offences referred to in Article 2(2) of Framework Decision 2002/584/JHA, if it is punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years;

  • Serious illness means an accident, injury, illness, disease, or physical or mental condition that: poses imminent danger of death; requires inpatient care in a hospital, hospice, or residential medical facility; or requires continuing in-home care under the direction of a physician or health care provider. Related current definitions are summarized in (f) below.

  • Serious Breach means any breach defined as a Serious Breach in the Contract or any breach or breaches which adversely, materially or substantially affect the performance or delivery of the Services or compliance with the terms and conditions of the Contract or the provision of a safe, healthy and supportive learning environment or a breach of security that adverselt affects the Personal Data or privacy of an individual. Failure to comply with Law, or actions or omissions by the Contractor that endanger the Health or Safety of Learners, Contractor Personnel, and all other persons including members of the public would constitute a Serious Breach;

  • serious offence means: (a) a crime or offence involving the death of a person; (b) a sex-related offence or a crime, including sexual assault (whether against an adult or child); child pornography, or an indecent act involving a child; (c) fraud, money laundering, insider dealing or any other financial offence or crime, including those under legislation relating to companies, banking, insurance or other financial services; or (d) an attempt to commit a crime or offence described in (a) to (c);

  • Serious offense means any of the following felonies or a felony attempt to commit any of the following felonies, as now existing or hereafter amended:

  • Serious traffic violation means a conviction when operating a commercial motor vehicle of:

  • serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • Serious damage means any specific defect described in this section, or any equally objectionable variation of any one of these defects, or any other de- fects, or any combination of defects, which seriously detracts from the ap- pearance or the edible or marketing quality of the individual portion of the kernel or of the lot as a whole. The fol- lowing defects shall be considered as serious damage.

  • Likelihood of serious harm means either: (a) A substantial

  • Serious means violations that result in one or more negative outcomes and significant actual harm to residents that does not con­ stitute imminent danger; and/or, there is reasonable predictability of recurring actions, practices, situations or incidents with potential for causing significant harm to a resident.

  • Serious Mental Illness . means the following mental disorders as classi­

  • Serious Misconduct means any misconduct identified as a ground for termination in the Motorola Code of Business Conduct, or the human resources policies, or other written policies or procedures.

  • Mysterious Disappearance means any disappearance of Property which, after a reasonable investigation has been conducted, cannot be explained.

  • Infectious Disease means an illness that is capable of being spread from one person to another.

  • Noxious weed means any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment. Noxious weeds will generally possess one or more of the characteristics of being aggressive and difficult to manage, parasitic, a carrier or host of deleterious insects or disease, and being non-native, new to, or not common to the United States or parts thereof.

  • Serious Medical Condition means a condition which, in Our opinion, constitutes a serious medical emergency requiring urgent remedial treatment to avoid death or serious impairment to Your immediate or long-term health prospects. The seriousness of the medical condition will be judged within the context of Your geographical location, the nature of the medical emergency and the local availability of appropriate medical care or facility.

  • Imminent health hazard means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on:

  • Infectious agent means that term as defined in R 325.9031 of the Michigan administrative code.

  • Behavioral violation means a student’s behavior that violates the district’s discipline policies.

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.