Abuse, Misuse, or Medication Error Sample Clauses

Abuse, Misuse, or Medication Error. Abuse is the persistent or sporadic, intentional excessive use of the study treatment which is accompanied by harmful physical or psychological effects. A medication error is any preventable incident that may cause or lead to inappropriate study treatment use or patient harm while the study treatment is in the control of the health care professionals or patients. Such incident may be due to health care professional practice, product labeling, packaging and preparation, procedures for administration, and systems, including the following: prescribing, order communication, nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use. All occurrences of abuse, misuse, or medication error with any study treatment are to be recorded on an SAE report form and sent to Karyopharm Pharmacovigilance, regardless of whether or not an AE or SAE has occurred due to the abuse, misuse, or medication error. If the abuse, misuse, or medication error is associated with an SAE, the SAE report form must be submitted to Karyopharm Pharmacovigilance within 24 hours of awareness. If there is no AE or SAE, the report must be submitted within 24 hours of awareness. ‌‌‌‌‌‌‌‌‌‌‌‌‌ any null hypothesis is not rejected in this sequence of tests, formal sequential testing will be stopped and the analyses of any endpoints thereafter will be nominal only. • Time to recovery defined as improvement from baseline score of 3 to ≥4 or from a baseline score of 4 to ≥5 • Proportion of patients with at least a 2 point improvement (increase) in the Ordinal Scale from baseline to Day 7. • Proportion of patients with at least a 1 point improvement (increase) in the Ordinal Scale from baseline to Day 7 • Proportion of patients with at least a 1 point improvement (increase) in the Ordinal Scale from baseline to Day 14. • Time to an improvement of 2 point using WHO Ordinal Scale Improvement (TTCI-2) • Time to clinical improvement (TTCI-1): defined as the time from randomization to an improvement of 1 point on the Ordinal Scale • Overall Death rate on Day 28 (DR) • Rate of mechanical ventilation (RMV) The difference in binary endpoints between treatment arms will be calculated with a 95% confidence interval (CI). Comparison of the these endpoints between the 2 treatment arms will be performed using the Xxxxxxx-Xxxxxx-Haenszel (CMH) test stratified by the randomization stratification factors. The CMH estimate of the odds ratio and its 95% CI and the p-value for testin...
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Related to Abuse, Misuse, or Medication Error

  • Unauthorized Use or Disclosure The Contractor shall notify COMMERCE within five (5) working days of any unauthorized use or disclosure of any confidential information, and shall take necessary steps to mitigate the harmful effects of such use or disclosure.

  • SEXUAL EXPLOITATION 22.1 The Contractor shall take all appropriate measures to prevent sexual exploitation or abuse of anyone by it or by any of its employees or any other persons who may be engaged by the Contractor to perform any services under the Contract. For these purposes, sexual activity with any person less than eighteen years of age, regardless of any laws relating to consent, shall constitute the sexual exploitation and abuse of such person. In addition, the Contractor shall refrain from, and shall take all appropriate measures to prohibit its employees or other persons engaged by it from, exchanging any money, goods, services, offers of employment or other things of value, for sexual favors or activities, or from engaging in any sexual activities that are exploitive or degrading to any person. The Contractor acknowledges and agrees that the provisions hereof constitute an essential term of the Contract and that any breach of this representation and warranty shall entitle UNDP to terminate the Contract immediately upon notice to the Contractor, without any liability for termination charges or any other liability of any kind.

  • Infringing Products or Services If the use of any Products or Services is enjoined (collectively, “Infringing Products”), Supplier shall at its expense procure the right for DXC to continue using or receiving the Infringing Products. If Supplier is unable to do so, Supplier shall at its expense (and at Indemnitees’ option): (i) replace the Infringing Products with non-infringing Products or Services of equivalent form, function and performance; or (ii) modify the Infringing Products to be non-infringing without detracting from form, function or performance; or

  • Abuse, Neglect, Exploitation Grantee will;

  • Medication 1. Xxxxxxx’s physician shall prescribe and monitor adequate dosage levels for each Client.

  • SUBSTANCE ABUSE POLICY 6.6.1. Labor and Management are committed to providing employees with a drug-free and alcohol-free workplace. It is the goal to protect the health and safety of employees and to promote a productive workplace, and protect the reputation of Labor and Management and the employees.

  • Anti-­‐Abuse Policy i. Registry Operator’s Anti-­‐Abuse Policy will be required under the Registry Registrar Agreement and posted on the Registry Operator’s web site.

  • Substance Abuse Program The SFMTA General Manager or designee will manage all aspects of the FTA-mandated Substance Abuse Program. He/she shall have appointing and removal authority over all personnel working for the Substance Abuse Program personnel, and shall be responsible for the supervision of the SAP.

  • COUNTERFEIT WORK (a) The following definitions apply to this clause:

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