Overall Response Sample Clauses

Overall Response. The overall response (OR) according to irRECIST is derived from the responses in TMTB as well as the presence of any non-target lesions as follows: • Complete Response (irCR): Complete disappearance of all lesions (whether measurable or not); lymph nodes must decrease to < 10 mm in shortest dimension • Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline • Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD • Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir The immune-related best overall response (irBOR) is the best irRECIST OR over the study as a whole, recorded between the date of first dose until the last TA prior to subsequent anticancer therapy for individual subjects. An assessment of disease progression at or before week 12 (unconfirmed irPD at week 12) will not preclude an irBOR of irCR, irPR, or irSD. Conversely, an assessment of irPD at or after Week 12 (confirmed irPD at week 12), will preclude a subsequent irBOR of irCR, irPR, or irSD. However, any post-progression clinical activity in subjects with irBOR of irPD may be summarized for exploratory purposes. Remainder of page intentionally left blank. Table 9: Best Overall Response (irBOR) Target Lesions Baseline (Index) and New Measurable Lesions Non-Target Lesions* irRC Overall Response Total Measurable Tumor Burden (TMTB) Baseline Lesions Unequivocal New Lesions irCR irCR No irCR irCR irSD No irPR irPR irCR or irSD No irPR irSD irCR or irSD No irSD irPD Any Yes or No irPD Any Unequivocal Progression Yes or No irPD Any Any Yes irPD *Any increase in the size or number of non-measurable lesions does not necessarily imply an overall response of irPD. If new lesions become measureable (≥ 10 mm) at a subsequent TA, their measurement will at that point start to contribute to the TMTB. To achieve unequivocal progression of non-target lesions, there must be an overall level of substantial worsening in non-target disease that is of a magnitude that the treating physician would feel it is important to change therapy. Equivocal findings of progression of non-target lesions (e.g., small and uncertain new lesions; cystic changes or necrosis in existing locations) should be considered irSD and treatment may continue until the next schedule assessment. Remainder of page intentionally left blank.
Sample 1
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Related to Overall Response

  • Emergency Response Partners must develop, maintain, and carry out a response plan for public water system emergencies, including disease outbreaks, spills, operational failures, and water system contamination. Partners must notify DWS in a timely manner of emergencies that may affect drinking water supplies.

  • Agency Response a. OGS will consider all information relevant to the Formal Dispute, and may, in its discretion, suspend, modify, or cancel the disputed procurement/Contract action prior to issuance of a Formal Dispute decision.

  • Spill Responsibility PURCHASER will be held responsible for any and all releases of environmental pollution during performance of the contract which occur as a result of, or are contributed by, actions of its agent, personnel, or subcontractors. PURCHASER agrees to promptly dispose of such spills or leaks to satisfaction of the STATE and proper regulatory agencies in a manner that complies with applicable federal, state, and local laws and regulations. Cleanup shall be at no cost to the STATE. PURCHASER shall obtain the STATE's written consent prior to bringing onto the areas of operations any

  • Fiscal Responsibility It is understood and agreed that the total amount of the funds used under this Agreement shall be used only for the project as described in the application and award documentation. Therefore, should the project not be completed, the Subrecipient shall reimburse said funds directly to the AZDOHS immediately. If the project is completed at a lower cost than the original budget called for, the amount reimbursed to the Subrecipient shall be for only the amount of dollars actually spent by the Subrecipient in accordance with the approved application. For any funds received under this Agreement for which expenditure is disallowed by an audit exemption or otherwise by the AZDOHS, the State, or Federal government, the Subrecipient shall reimburse said funds directly to the AZDOHS immediately.

  • Additional Responsibilities You agree to: reasonably clean and maintain Covered Items; not harm/damage a Covered Item or Component; provide a safe working environment for Contractors; not damage property of a Contractor; and not threaten/harm us or a Contractor via phone, email, personal interaction, internet, social media or otherwise.

  • Firm Response The Department should make an award within sixty (60) days after the date of the opening, during which period responses shall remain firm and shall not be withdrawn. If award is not made within sixty (60) days, the response shall remain firm until either the Department awards the Contract or the Department receives from the bidder written notice that the response is withdrawn. Any response that expresses a shorter duration should, in the Department's sole discretion, be accepted or rejected.

  • Government’s Response Please refer to the Q&A from the first question.

  • General Responsibility The Consultant shall, at all times during the Agreement, remain responsible. The Consultant agrees, if requested by the Commissioner of NYSDOT or his or her designee, to present evidence of its continuing legal authority to do business in New York State, integrity, experience, ability, prior performance, and organizational and financial capacity.

  • Fiscal Responsibilities ‌ The School shall maintain accurate and comprehensive financial records, practice governmental accounting in accordance with Generally Accepted Accounting Principles, and use public funds in a fiscally responsible manner.

  • General Responsibilities Issuer hereby engages Distributor to act as exclusive distributor of the shares of each class of the Funds. The Funds subject to this Agreement as of the date hereof are identified on SCHEDULE A, which may be amended from time to time in accordance with Section 11 below. Sales of a Fund's shares shall be made only to investors residing in those states in which such Fund is registered. After effectiveness of each Fund’s registration statement, Distributor will hold itself available to receive, as agent for the Fund, and will receive by mail, telex, telephone, or such other method as may be agreed upon between Distributor and Issuer, orders for the purchase of Fund shares, and will accept or reject such orders on behalf of the Fund in accordance with the provisions of the applicable Fund’s prospectus. Distributor will be available to transmit orders, as promptly as possible after it accepts such orders, to the Fund’s transfer agent for processing at the shares’ net asset value next determined in accordance with the prospectuses.

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